As part of its two-day series of meetings, an FDA advisory committee unanimously concluded that a second Johnson & Johnson COVID-19 vaccine dose should be administered and suggested that the vaccine performs better as a two-dose series.
In Moderna news, the FDA is holding off on its decision on whether to expand use of the shot to 12-17-year-olds while it looks into risk of a rare heart condition.
The worldwide case count stood at more than 239.9 million Friday afternoon, with more than 4.89 million reported deaths, according to Johns Hopkins University's COVID-19 dashboard.
Please read below for the latest updates. Daily COVID-19 tracker entries from Nov. 2 to April 28 can be found here. Entries from Aug. 11 to Oct. 30 are here. Entries from April 21 through Aug. 11, 2020, are here. Entries from Jan. 30 through April 20, 2020, are here.
UPDATED: Friday, October 15 at 4:30 p.m.
A second dose of the Johnson & Johnson COVID-19 vaccine was recommended Friday by an FDA advisory committee. While the recommendation covered all adults, there was much discussion as to whether the second dose should be called a booster or not. Story
The FDA is delaying its decision on authorizing the Moderna vaccine for adolescents ages 12-17 over rare myocarditis side effect concerns, The Wall Street Journal reports.
UPDATED: Friday, October 15 at 10 a.m.
The U.S. will open its borders to vaccinated foreign travelers on Nov. 8. The measures are the biggest changes to U.S. travel policy since the beginning of the pandemic, Bloomberg reports. The Nov. 8 date applies to air travel as well as land-borders as announced earlier this week. Under the new system, vaccinated people who have had a negative COVID-19 test in the prior 72 hours and share contact tracing information will be able to board a flight to the U.S. Meanwhile, unvaccinated travelers will generally be barred from entry. Unvaccinated Americans will need a negative test.
Following the Moderna recommendation, the advisory panel will vote today on the authorization of an additional shot of the Johnson & Johnson vaccine, Reuters reports.
President Biden announced the donation of 17 million doses of the Johnson & Johnson vaccine to the African Union during a meeting with Kenyan President Uhuru Kenyatta, The New York Times reports. The donation comes a month after Kenyatta publicly pleaded for more equitable global vaccine distribution.
UPDATED: Thursday, October 14 at 4:15 p.m.
Advisers to the FDA recommended additional doses of the Moderna vaccine Thursday afternoon for people over 65 and those at high risk, The Wall Street Journal reports.
As the advisory committee meets to discuss Moderna and Johnson & Johnson boosters, InCrowd data showed U.S. doctors estimate 54% of Pfizer-vaccinated patients got or plan to receive a booster. Meanwhile, 86% support an additional Pfizer shot for key groups.
During a speech Thursday, President Biden urged states and private business to "step up" and support vaccine mandates to help avoid a surge in cases, The New York Times reports.
UPDATED: Thursday, October 14 at 10 a.m.
An advisory panel to the FDA is expected to vote Thursday on whether to recommend emergency use authorization of an additional shot for Moderna vaccine recipients, The New York Times reports. The panel will meet over the next two days to discuss Moderna and Johnson & Johnson boosters.
The FDA is currently not taking a stand on an additional third Moderna dose and an additional second Johnson & Johnson dose, saying the vaccines are already working as authorized. Story
A National Institutes of Health study showed people who received the Johnson & Johnson vaccine had a stronger immune response when boosted four to six months after they received their first J&J dose with the Pfizer or Moderna vaccines as compared J&J's, Reuters reports.
South Korea will donate almost 1.6 million doses of the AstraZeneca vaccine to Vietnam and Thailand this week, The New York Times reports.
UPDATED: Wednesday, October 13 at 4 p.m.
An FDA staff assessment said Johnson & Johnson's booster of its vaccine showed signs of significantly bolstering immune defenses, The Wall Street Journal reports. However, federal health regulators cautioned on Wednesday the data was limited and that they relied on J&J's own analysis.
Biogen announced that data for its portfolio of multiple sclerosis therapies showed the treatments mount an effective antibody response to COVID-19 vaccines among people with MS.
The Biden administration will ease COVID-19 travel restrictions at Canada and Mexico land-border crossings for those fully vaccinated, The Wall Street Journal reports. Beginning in November, travelers, including for nonessential reasons, will be required to show proof of vaccination.
UPDATED: Wednesday, October 13 at 10:30 a.m.
The AstraZeneca COVID-19 vaccine will no longer be manufactured in Australia because of high demand for Pfizer and Moderna and criticism over the AstraZeneca vaccine, 9 News reports.
Moderna data showed an additional half-dose of its vaccine at least six months after the second dose increased antibody levels. The company argues the FDA should authorize a half-dose as a booster, The New York Times reports. An advisory panel is expected to meet to discuss data on both Moderna and Johnson & Johnson booster doses and emergency authorization later this week. Story
Moderna also said it has no plans to share the recipe for its COVID-19 vaccine, AP reports. Executives said scaling up Moderna's own production is the best way to increase global supply.
UPDATED: Tuesday, October 12 at 4:30 p.m.
The World Health Organization recommended additional doses for severely or moderately immunocompromised people of the seven COVID-19 vaccines it previously authorized, The New York Times reports.
Biopharma CSL will mandate COVID-19 vaccines for its entire workforce and said the AstraZeneca vaccine had been subject to “disproportionate criticism."
Texas Gov. Greg Abbott issued a broad executive order on Monday that bars COVID-19 vaccine mandates, The New Times reports. The latest executive order includes private employers, which had been previously exempt from edicts against the mandates.
UPDATED: Tuesday, October 12 at 10 a.m.
Merck aims to double manufacturing capacity for its oral antiviral next year, the Financial Times reports. The news follows Merck's move yesterday to file a request for emergency use authorization for the pill. The company has scored deals with Singapore, New Zealand, Australia and South Korea to supply doses and is in talks with more governments. While concerns grow over access to the drug for poorer nations, Merck also entered into licensing deals with generic manufacturers to make cheaper versions of the drug. The generic drugmaker Everest Organics in India started production of the drug and began manufacturing active pharmaceutical ingredients for it. Story
German biotech CureVac is ditching its first mRNA COVID-19 vaccine after low efficacy results. CureVac will instead switch focus to a second mRNA asset with GlaxoSmithKline. Story
More than two weeks after the World Health Organization recommended Roche's COVID-19 treatment, the company has applied to market the anti-COVID-19 cocktail in the EU, Medical Press reports. The Swiss pharma giant co-developed the treatment with U.S. biotech firm Regeneron.
When the U.S.'s travel regulations take action next month, Canadians vaccinated with the AstraZeneca vaccine can visit the U.S., CP24 reports. However, there are concerns over whether those with mixed doses will be included. The CDC said the U.S. will welcome travelers if they've received shots of vaccines approved or recognized for emergency use by the FDA or WHO.
UPDATED: Monday, October 11 at 4 p.m.
Merck requested emergency use authorization from the FDA for its COVID-19 antiviral treatment molnupiravir. Recently reported data showed the pill cut hospitalizations and deaths by about half in early trials and could be an important tool globally. Story
Advisers to the FDA are expected to meet on Thursday and Friday to discuss booster doses of the Johnson & Johnson and Moderna vaccines, The New York Times reports.
A study of AstraZeneca's antibody cocktail showed it saved lives and prevented severe COVID-19 when given as a treatment within a week of first symptoms, Reuters reports. The treatment was also proven to work as a preventative shot in those not infected.
UPDATED: Monday, October 11 at 10 a.m.
The FDA said distribution of GlaxoSmithKline and Vir Biotechnology's COVID-19 antibody treatment would be controlled by the government, Reuters reports.
In the U.K., the government bought 100,000 doses of the GSK antibody treatment, City A.M. reports. Regulators have approved the treatment in the U.S., EU and Japan but it has yet to be approved in the U.K.
Russian spies stole the blueprint for the AstraZeneca vaccine, and the country used that info to create the Sputnik V vaccine, security officials reportedly briefed ministers.
UPDATED: Friday, October 8 at 4:30 p.m.
CDC advisers will review its recommendations on booster doses of Moderna and Johnson & Johnson vaccines, Reuters reports.
President Joe Biden said vaccine mandates for workers are not only effective in improving vaccine rates but also important to the U.S. workforce and economy. Story
In response to California’s recent mandate for students to be vaccinated, Illinois Rep. Tom Weber, R-Fox Lake, filed a bill to block any potential mandate for Illinois students to get the vaccine ahead of an FDA vote later this month, Patch reports.
UPDATED: Friday, October 8 at 9:50 a.m.
As part of the effort to require 80 million U.S. workers to get vaccinated, President Biden on Thursday urged companies to mandate COVID-19 vaccinations for employees, The New York Times reports.
Two Indian drugmakers have requested to end late-stage trials on Merck's oral antiviral molnupiravir in moderate COVID-19 patients after the companies submitted interim clinical trial data around the effectiveness of the drug, Reuters reports. However, the drugmakers plan to continue late-stage trials of the drug in mild COVID-19 patients.
Similarly, an India regulatory source with the Drug Controller General of India said molnupiravir has not shown significant efficacy against moderate COVID-19, Reuters reports.
Finland joined Sweden and Denmark in limiting the use of Moderna's vaccine. The country paused the use of the vaccine for younger males, citing reports of a rare cardiovascular side effect, Reuters reports.
Baltimore-based biotech Elixirgen Therapeutics announced the company entered into a licensing agreement with an undisclosed pharma company for rights to commercialize its RNA COVID-19 vaccine candidate around the world.
UPDATED: Thursday, October 7 at 3:45 p.m.
Although Moderna has committed to making 500 million doses for low- and middle-income countries, the White House is pushing for more to be donated, causing tension on both sides. Story
The CDC said both the flu and COVID-19 vaccines can be administered during the same visit.
Similarly, a Sanofi study found its Fluzone high-dose quadrivalent vaccine and a Moderna COVID-19 booster given in the same doctor’s visit showed that both provide similar immunogenicity responses to when they are provided individually. Story
Following Sweden's pause on the Moderna vaccine for young people, Scandinavian authorities also suspended or discouraged the Moderna vaccine in young people because of an increased risk of heart inflammation, AP reports. Denmark said those under 18 won’t be offered the vaccine while Norway encouraged those under 30 to get the Pfizer/BioNTech vaccine instead.
UPDATED: Thursday, October 7 at 9:53 a.m.
Pfizer and BioNTech asked the FDA to authorize their vaccine for emergency use in children ages 5 to 11. If the FDA moves quickly on the application, vaccinations could begin by Halloween, The Wall Street Journal reports.
As Merck's molnupiravir data generate a global buzz, analysts are sizing up the potential market. Even after COVID-19 moves into an endemic phase, oral antivirals could still bring in blockbuster sales, one analyst wrote. Merck stands to capture a sizable portion of that market. Story
Amid the ongoing debate over boosters, real-world data indicate that immunity from Pfizer's COVID-19 shot starts wearing off after about two months, CNN reports. The vaccine is still highly effective against severe disease, hospitalization and death, according to the research. The data release comes after U.S. officials signed off on Pfizer boosters for some people.
UPDATED: Wednesday, October 6 at 4 p.m.
Los Angeles will require people to provide proof of vaccination to enter a range of indoor businesses, including restaurants, gyms, museums, movie theaters and salons, The New York Times reports. The new law will grant exceptions for people with medical conditions that do not allow them to be vaccinated or people who have a religious objection. These individuals will instead be required to show proof of a negative coronavirus test taken within the prior 72 hours.
The White House plans to expand access to rapid, at-home COVID-19 tests by investing $1 billion to purchase them, The Washington Post reports.
Canada's Prime Minister Justin Trudeau said the country will require vaccinations for federal workers on Oct. 29 in addition to air and rail passengers as of next Tuesday, The New York Times reports.
Three countries have now unveiled deals with Merck to secure its oral antiviral. Story
UPDATED: Wednesday, October 6 at 10 a.m.
Sweden paused the use of the Moderna vaccine for people born in 1991 or later following reports of rare side effects like myocarditis, Reuters reports.
Merck entered an agreement with Singapore to provide the country with access to its COVID-19 oral antiviral, Reuters reports. This follows Australia's move to buy the pill as well. Thailand, South Korea, Taiwan and Malaysia are in talks to buy the drug.
Nearly 5 million AstraZeneca vaccines that were headed to Great Britain were taken by France last spring, The Daily Mail reports.
Pfizer will vaccinate a Brazilian town's whole population over the age of 12 to study the effectiveness of the vaccine, Reuters reports.
UPDATED: Tuesday, October 5 at 3:30 p.m.
Following its endorsement of Pfizer/BioNTech booster shots, the European Medicines Agency authorized a third dose of the Moderna vaccine to be given at least 28 days after the second dose to severely immunocompromised individuals aged 12 and older.
The CDC removed the holiday guidelines the agency issued previously and is working on updated recommendations, NBC reports.
A study found the Pfizer/BioNTech vaccine to be 90% effective at preventing hospitalization for up to six months, with no signs of waning, The New York Times reports. The vaccine also shows protection against the delta variant.
New Zealand Prime Minister Jacinda Ardern said the country will abandon its zero-COVID strategy and gradually lift its restrictions in Auckland, The New York Times reports. An outbreak in August, sparked by the delta variant, sent Auckland into a lockdown.
UPDATED: Tuesday, October 5 at 9 a.m.
Johnson & Johnson submitted an anticipated request for emergency use authorization from the FDA for a second dose to be added to its authorized single dose as a booster. The move follows company data that reported the two-dose regimen increased protection to 94% against moderate to severe COVID-19 cases.
AstraZeneca filed a request for emergency use authorization for its COVID-19 antibody cocktail. Story
In an effort to increase access to rapid testing, the FDA approved emergency use authorization for over-the-counter home COVID-19 antigen tests.
Despite decreased effectiveness over time, the Pfizer/BioNTech vaccine still protects people from hospitalization. A study found the vaccine falls from 88% a month after the second dose to 47% six months later, CNBC reports.
Merck's COVID-19 antiviral pill was originally developed at Emory University with $35 million of taxpayer grants, Axios reports. This means the federal government owns rights to some of molnupiravir's patents and could affect future purchasing agreements.
UPDATED: Monday, October 4 at 4 p.m.
An expert committee for the European Medicines Agency issued a wide endorsement for COVID-19 booster shots from Pfizer/BioNTech.
As vaccine mandates roll out across the country, a COVID-19 vaccination requirement for teachers and other staff has taken effect for New York City's public school system, AP reports.
The CDC issued guidelines ahead of the approaching holiday season, recommending outdoor gatherings and use of fans when indoors, NPR reports.
UPDATED: Monday, October 4 at 9:30 a.m.
Johnson & Johnson is planning to ask U.S. regulators this week to authorize its booster shot for its COVID-19 vaccine, The New York Times reports.
The FDA will hold advisory committee meetings to discuss new data and emergency use authorizations for booster doses and vaccines for younger children. On Oct. 14 and 15, the advisory committee will discuss the use of booster doses of the Moderna and Johnson & Johnson's Janssen vaccine. In anticipation of Pfizer's request for its emergency use authorization for its vaccine in children ages 5 to 11, the committee scheduled a meeting for Oct. 26.
A pre-print study that claimed there was a one in 1,000 risk of myocarditis following vaccination with an mRNA shot was found to contain errors and was retracted. Researchers said the reported incidence of inflammation was inflated due to underestimating the total number of vaccines administered over a two-month period.
The goal to vaccinate the rest of the global population, including poor countries, is still on, and vaccine makers say there are enough doses for everyone. However, health experts say many doses risk going unused in high-income countries, The Wall Street Journal reports.
Dr. Kayvon Modjarrad, an emerging-infectious-diseases researcher with the U.S. Army, is working to develop one vaccine to protect against a range of coronavirus variants, The Wall Street Journal reports.
UPDATED: Friday, October 1 at 4 p.m.
In California, Gov. Gavin Newsom said the state will require all eligible students to be vaccinated once the FDA grants full approval for the vaccine for people 12 and older. It's the first mandate of its kind in the U.S., The Wall Street Journal reports.
New York's mandate to require healthcare workers to be vaccinated was blocked just days after it went into effect, NBC reports. A judge issued a temporary and partial injunction, granting religious related exemption, Thursday, against Gov. Kathy Hochul's mandate. A panel set a hearing for Oct. 14.
Dr. Anthony Fauci said Merck's antiviral pill has shown "impressive" results following news of its positive clinical trials results, Politico reports.
UPDATED: Friday, October 1 at 9:30 a.m.
Merck stopped its study and is racing to get emergency use authorization for its oral antiviral after its phase 3 trial showed that the pill halved the risk of hospitalization and death. The antiviral, molnupiravir, aims to stop people from developing severe COVID-19. Story
"Human error" is to be blamed for the contamination found in three Moderna vaccine lots in Japan, Moderna and its Japanese distributor Takeda said. Metallic particles were present in vials, causing Japan to suspend the use of the three lots five weeks ago. Story
UPDATED: Thursday, September 30 at 4 p.m.
In an effort to increase vaccinations worldwide, the U.S. sent 1.6 million doses of Pfizer/BioNTech's Comirnaty to Egypt as part of the COVAX initiative, Reuters reports.
Biotech Laurent Pharmaceuticals' phase 2 clinical trial for its oral COVID-19 treatment was unsuccessful in meeting its goal to improve the proportion of hospitalized patients alive and free of respiratory failure on day 29. Story
UPDATED: Thursday, September 30 at 9:30 a.m.
AstraZeneca's vaccine demonstrated 74% efficacy at preventing symptomatic COVID-19 in a large U.S. clinical trial, Reuters reports. For people 65 and older, efficacy increased to 83.5%. The company anticipates submitting an application for emergency use authorization, AstraZeneca's vice president said. Story
Recent data from Regeneron showed positive results for its antibody cocktail, REGEN-COV. The drug reduced the risk of death by 36% over placebo at day 29 in the overall population. The FDA is currently reviewing a request to add hospital settings to REGEN-COV's emergency use authorization. Story
UPDATED: Wednesday, September 29 at 4:15 p.m.
Dr. Anthony Fauci said the FDA's decision on whether to approve the Pfizer/BioNTech vaccine for children ages 5 to 11 could come in November, Reuters reports.
Hospitals and health systems across the U.S. are losing employees to vaccine mandates as deadlines for required vaccinations near. New York saw its deadline for healthcare workers across the state to be vaccinated pass on Monday. Story
Outside the U.S., Poland sent over 100,00 doses of the AstraZeneca vaccine to Egypt, Reuters reports.
UPDATED: Wednesday, September 29 at 9:30 a.m.
The FDA is considering authorizing the Moderna booster at a half dose, Bloomberg reports. Half-dose boosters would greatly expanded Moderna's expected capacity.
Merck's oral antiviral molnupiravir showed promise against COVID-19 variants in preclinical trials, Chemical & Engineering News reports. The therapeutic is now in two phase 3 clinical trials.
Slovenia temporarily suspended use of Johnson & Johnson's vaccine after the death of a woman, Reuters reports.
UPDATED: Tuesday, September 28 at 4 p.m.
The White House said more than 400,000 Americans received booster shots of the Pfizer/BioNTech vaccine over the weekend at pharmacies alone, Reuters reports.
A BD study showed its glass prefilled syringes are suitable for storing mRNA shots that need to be kept at ultralow temperatures. Story
Data from NIH trials that mixed boosters and initial doses from Pfizer, Moderna and Johnson & Johnson could be available within the next two weeks, Dr. Anthony Fauci told CNBC.
UPDATED: Tuesday, September 28 at 9:30 a.m.
Pfizer and BioNTech submitted initial data to the FDA from a phase 2/3 trial of their vaccine in children 5 to 11 that showed "favorable" safety outcomes. A formal submission to request emergency use authorization is expected to follow in the coming weeks.
Following the successes of giants Pfizer/BioNTech and Moderna, Sanofi is dropping development of its own mRNA-based COVID-19 vaccine. Sanofi will instead pursue efforts with GSK on a separate vaccine candidate. Story
Dr. Peter Marks, one of the FDA's top officials, took over the agency's vaccines office Monday after two leaders previously announced their departures and raised concerns over boosters.
UPDATED: Monday, September 27 at 4 p.m.
Pfizer board member and former FDA commissioner Dr. Scott Gottlieb said the delta variant could be the last major wave of infection, Pharmaceutical Processing World reports. Gottlieb, who served as FDA commissioner from 2017 to 2019, said the surge could be done by Thanksgiving.
President Joe Biden received a third dose of the Pfizer/BioNTech vaccine. The White House publicly broadcasted the vaccination Monday, hoping to encourage others to receive their boosters too, NPR reports.
UPDATED: Monday, September 27 at 9:30 a.m.
Pfizer CEO Albert Bourla told ABC News the company will soon be ready to submit vaccine data from children ages 5 to 11 to the FDA for a potential approval.
Meanwhile, Pfizer is also jumping into a phase 2/3 clinical trial for an oral antiviral candidate for adults exposed to COVID-19. The therapeutic aims to prevent infection. Story
Sanofi and GSK scored an approval to start a phase 3 trial for their COVID-19 vaccine candidate in Nepal. The International Vaccine Institute (IVI) will lead the trial.
UPDATED: Friday, September 24 at 10 a.m.
CDC director Rochelle Walensky rejected a CDC advisory panel's recommendation that boosters should not be administered to workers who could get an infection through their jobs. The panel previously only recommended Pfizer/BioNTech third doses for those older than 65 and those at a high-risk of severe infection.
The World Health Organization endorsed Regeneron and Roche's COVID-19 drug with the request that companies offer the treatment at a discount and distribute it equitably. Story
Following its $60.5 million fundraise this week, SAB Biotherapeutics said its trial for SAB-185 will advance to phase 3. The therapeutic candidate aims to treat non-hospitalized patients with mild-to-moderate COVID-19 cases.
Novavax's phase 3 trial for its NanoFlu influenza vaccine showed significantly enhanced cell-mediated immune responses and achieved all primary endpoints. The news comes as the biotech aims to advance a combination COVID-influenza vaccine.
Florida purchased 3,000 doses of GlaxoSmithKline's monoclonal antibody treatment. Gov. Ron DeSantis said the shipment could be used to offset the declining federal distributions of Regeneron's COVID-19-fighting drug.
UPDATED: Thursday, September 23 at 4 p.m.
Biotech Novavax and its partner Serum Institute of India submitted an application to the World Health Organization for emergency use listing for their COVID-19 vaccine.
In a study of 36 newborns whose mothers received either Pfizer or Moderna mRNA COVID-19 vaccines, 100% of the babies were found to have protective antibodies, Bloomberg reports. Researchers are looking at results in a larger sample size.
After the U.S.'s greenlight for Pfizer/BioNTech booster shots, the European Medicines Agency (EMA) is aiming to decide in early October whether to endorse a third dose of the Pfizer/BioNTech vaccine, Reuters reports.
UPDATED: Thursday, September 23 at 10 a.m.
The FDA granted emergency authorization on Wednesday to administer third doses of the Pfizer/BioNTech vaccine to Americans older than 65 or to those who are at high risk. The CDC will meet again today to discuss administration plans.
Meanwhile, a federal health official said the Pfizer/BioNTech vaccine should not be administered to those who previously got a different COVID-19 vaccine, The Wall Street Journal reports. There aren't enough data to support mixing vaccines, the official said.
A trial studying the Moderna shot showed the vaccine has a 98% efficacy against severe cases after more than five months following the second shot, Endpoints News reports.
Specialty vaccine company Valneva said it will continue to expand its clinical trials of its inactivated COVID-19 vaccine candidate in the U.K. The company is recruiting adolescents for its phase 3 clinical trial and expects results early in the fourth quarter of 2021.
Gilead reported an 87% decrease in the risk of hospitalization for those treated with Veklury via IV for three days.
UPDATED: Wednesday, September 22 at 4 p.m.
Amid efforts to vaccinate poor countries, Amnesty International said in a report that COVID-19 vaccine makers AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer have refused to waive intellectual property rights on their shots. The group is calling for 2 billion doses to be delivered to low- and lower-middle income countries by the end of the year. Story
HealthVerity is teaming up with Johnson & Johnson's pharma unit Janssen to provide real-world data to use for clinical trials and R&D work. Story
The U.S. Department of Defense awarded biopharma SAB Biotherapeutics an additional $60.5 million for its DiversitAb Rapid Response Antibody Program. The funds will also help the company advance its therapeutic candidate for treating COVID-19 to the clinical stage.
UPDATED: Wednesday, September 22 at 9:30 a.m.
A CDC committee will meet today and Thursday to again discuss the science and possible administration plan for Pfizer/BioNTech's COVID-19 booster shots.
To expand efforts to vaccinate developing countries, Pfizer and BioNTech announced plans to expand their agreement with the U.S. by providing 500 million additional vaccine doses at a not-for-profit price to be donated. This brings the total of doses supplied for donation to other countries to 1 billion.
Slow enrollment has delayed Pfizer/BioNTech's study of their vaccine in pregnant women, The Wall Street Journal reports. Changing guidelines and concerns over receiving placebo have held up enrollment.
Biotech Codagenix announced its intranasal COVID-19 vaccine Phase 1 trial has shown safety and immunogenicity results. The company said it intends to continue on to Phase 2 and 3.
UPDATED: Tuesday, September 21 at 4:00 p.m.
The U.S.'s pledge to help vaccinate developing countries faces struggles including lack of infrastructure and resources. The Biden administration plans to call for more global aid at the U.N. General Assembly on Wednesday. About 137 million doses have been shipped so far, mostly doses from Moderna and Johnson & Johnson. By the end of June 2022, the administration expects to send 500 million Pfizer/BioNTech doses.
The FDA has alerted clinical laboratory staff and healthcare providers of a risk of false positive Abbott Laboratories COVID-19 test results. Amid a surge in demand for more tests, Abbott's Gurnee, Illinois, factory will reopen after closing operations four months ago.
Pharma company Eli Lilly announced its plan to supply up to 220,000 COVID-19 antibody combination doses to European countries. The company has entered an agreement with the European Commission to do so.
UPDATED: Tuesday, September 21 at 9:30 a.m.
The United States' death toll from the COVID-19 pandemic has now topped the 1918 flu pandemic.
Dr. Anthony Fauci said the AstraZeneca vaccine will be accepted by the U.S. for tourists despite the country not having authorized it. The U.S. announced it will accept international tourists come November.
Johnson & Johnson data show that a follow-up shot is 94% effective against mild-to-severe COVID-19 cases when given at two months after first dose.
India government officials told Reuters the government won't buy COVID-19 vaccines from Pfizer/BioNTech and Moderna as domestic output of more affordable vaccines has increased.
UPDATED: Monday, September 20 at 4:00 p.m.
The CDC led a nationwide study on the effectiveness of the Pfizer, Moderna and Johnson & Johnson vaccines in preventing hospitalizations from March 11 to Aug. 15. While all three provide substantial protection, the difference may come down to the amount of mRNA content in each vaccine and timing between doses, the CDC said. Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization was higher for the Moderna vaccine (93%) than for the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%).
Clinical-stage biotech company Gritstone announced its first volunteer has been dosed with its mRNA second generation COVID-19 vaccine in the company's Phase 1 trial. Data from the study are expected in the first quarter of 2022.
Biopharma Appili Therapeutics entered an agreement with Fujifilm Toyama Chemical, securing $1 million for its Phase 3 Preventing Secure COVID-19 (Preseco) clinical trial. The trial will evaluate the company's Avigan/Reeqonus tablets for the potential treatment and prevention of COVID-19.
UPDATED: Monday, September 20 at 9:00 a.m.
Pfizer said a smaller dose of its BioNTech-partnered vaccine was safe and effective in children between 5 to 11 years old. The company plans to submit the phase 2/3 trial data to regulatory authorities “as soon as possible.” The companies anticipate results in children under 5 as soon as later this year.
Following the FDA’s advisory committee meeting late last week, U.S. regulators are expected to OK Pfizer booster jabs for people 65 and older, as well as some high-risk Americans, early this week, Reuters reports. The decision will likely come before a CDC meeting on Wednesday, where the agency will craft precise recommendations over how to administer the shots.
Additional booster data from Moderna and Johnson & Johnson should be coming in just a matter of weeks, White House chief medical adviser Dr. Anthony Fauci said in an interview with CNN. U.S. health officials are advising that people wait for their booster until the FDA signs off.
CVS Health is gearing up for a busy fall and winter season with plans to hire 25,000 additional employees to help meet the high demand for flu and COVID-19 vaccines, as well as testing. Not only will the additional staff assist with flu jabs, but they’ll likely assist the company with administering booster jabs, pending regulatory approval, CVS said.
Knowing that bats can ward off many coronaviruses better than humans can, researchers at Monash University reviewed studies of the animal's immune responses to SARS-CoV-2, the virus behind COVID-19. Their findings could lead to new strategies for fighting the disease, such as reducing inflammasome signaling, they suggested. Story
UPDATED: Friday, September 17 at 4:15 p.m.
A key FDA advisory panel has voted against the full approval of a third dose of the Pfizer-BioNTech vaccine, Comirnaty, for those 16 years and over at least six months after the initial two-dose regimen. The decision that could serve as a blow to the Biden administration’s plans to start rolling out booster shots next week. The committee's overwhelming down vote will now be followed by a potential modification that could result in boosters for at-risk groups under an emergency use authorization.
The Biden administration is planning to purchase hundreds of millions more Pfizer doses that it plans to donate to the rest of the globe, the Washington Post reports. The White House’s announcement is set to coincide with a U.N. General Assembly meeting.
UPDATED: Friday, September 17 at 9:30 a.m.
A key FDA committee will meet today to discuss Pfizer’s application for a booster shot, a highly anticipated discussion that comes just ahead of the Biden administration’s expectations to start rolling out booster doses next week. The group will debate whether now is the time for U.S. residents to get an extra jab, a topic that could have ramifications for boosters beyond Pfizer alone.
Novavax will join a UK-based study that is testing how well a mix-and-match vaccine schedules protect adolescents against COVID-19, according to PharmaTimes. The Oxford University-led study, dubbed Com-COV3, will test a first shot of Pfizer’s vaccine mixed with a second dose of either another Pfizer jab at full or half dose, or a vaccine from Moderna or Novavax.
The European Union’s drug regulator couldn’t confirm from available data whether AstraZeneca’s two-dose vaccine caused higher rates of a rare blood clotting disorder, known as thrombosis with thrombocytopenia syndrome, or TTS, among women and adolescents.
The Indian government plans to roll out 10 million doses of Zydus Cadila’s vaccine, known as ZyCoV-D, by the end of October, according to a report from News18. India authorized Zydus’ DNA-based vaccine for emergency use a month ago.
UPDATED: Thursday, September 16 at 4:00 p.m.
Moderna has received its first full approval for its COVID-19 vaccine, dubbed Spikevax, in Canada for people aged 12 and older. Health Canada’s full approval was based on a final analysis of Moderna’s late-stage clinical trials, which enrolled more than 30,000 people, that found the shot was 93% effective and durable for six months after a second dose.
Eli Lilly has scored an expanded FDA nod for its antibody combo, a mix of its bamlanivimab and etesevimab, as a post-exposure prophylaxis treatment for those who have been recently exposed to the virus. The cocktail can now be used in people as young as 12 who are considered high risk and haven't been vaccinated or are not expected to mount an adequate immune response.
Very few United Airlines employees have resigned following the company’s decision to mandate vaccines by Sept. 27, and about 90% have now provided proof of vaccination, CEO Scott Kirby told CNN. The news comes as top health officials reportedly weigh making vaccination a requirement for air travel. While Kirby defended the administration’s order on employees, the United chief argued that it would likely cause more friction if required for travelling.
American rap artist Nicki Minaj has sparked backlash following a false claim made on Twitter that said a friend of her cousin in Trinidad became impotent after receiving the vaccine. Trinidad and Tobago Health Minister Terrence Deyalsingh criticized Minaj’s comments, saying officials “wasted so much time” ensuring the claims were false.
The FDA authorized two more batches of Johnson & Johnson’s COVID-19 vaccine produced at the Emergent BioSolutions Bayview facility, where the company halted production in April due to contamination issues, The Baltimore Sun reports. The Emergent facility has scored the green light to ship out eight batches. Story
UPDATED: Thursday, September 16 at 9:45 a.m.
The Access Consortium, which is made up of drug regulators from the U.K., Australia, Canada, Singapore and Switzerland, says that immunobridging studies can be used to support COVID-19 vaccine authorization as opposed to traditional placebo-controlled trials that use protection as an endpoint. Such traditional trials have had trouble attracting participants in some countries. Immunobridging studies use immune response biomarkers to compare vaccine efficacy in various populations.
The FDA has approved the release of two more Johnson & Johnson COVID-19 vaccine batches from the troubled Emergent plant in Baltimore. This brings the total number of J&J vaccine batches released from the plant after its closure and reopening to eight. Regulators closed the plant down and put vaccine batches on hold earlier this year after millions of doses were discarded because of possible contamination. The FDA also has approved the release of three AstraZeneca vaccine batches.
Pfizer will apply in November for emergency use authorization of its COVID-19 vaccine in children younger than 5. The company previously said it will apply for use of the shot in those aged 5-11 in October.
In an effort to boost tourism, Panama will offer AstraZeneca's COVID-19 vaccine, Vaxzevria, to visitors. The move comes as many countries in Central and South America are struggling to secure and administer shots.
Six unvaccinated members of a family in the Palm Beach, Florida, area have died of complications from COVID-19 in a span of three weeks. Tyrone Moreland, 48, was the first to perish in late August. Two days after the family gathered for his funeral, 89-year-old Lillie Mae Dukes. Three more cousins of Tyrone Moreland, including Shatara Dukes, 48, and Lisa Wiggins, 53, died early this month. Then last Sunday, Trentarian Moreland, 44, also died.
More than half of Americans believe the worst of the COVID-19 pandemic has yet to come, according to Pew Research. In a survey of 10,348 U.S. adults, conducted in the last week of August, 54% believe the virus remains a major threat. Of those surveyed, 73% said they had received at least one vaccine dose.
UPDATED: Wednesday, September 15 at 3:55 p.m.
Moderna has been forced to deal with contamination reports shrouding its vaccine vials in Japan, and now it’s Pfizer’s turn. Five unused vials of the company’s mRNA jab from the same lot were found to have white floating matter in them, although the company maintains the substance was likely ingredients that hadn’t fully dissolved. Story
FDA documents released ahead of the agency’s meeting on Friday to discuss Pfizer’s booster shot application indicate the agency’s staffers believe that the shots are working just fine, although they acknowledged “some observational studies” suggest immunity wanes over time. The FDA's Vaccines and Related Biological Products Advisory Committee plans to review the data and make recommendations to the agency. Story
As scientists and officials debate the need for boosters, Moderna said the latest breakthrough infection data support the case for follow-up doses. Moderna's vaccine remains "highly effective" even amid the delta surge, the company said, but data show that people who were vaccinated more recently were less likely to experience a breakthrough case.
The White House is working out how it plans to allow international travelers to enter the U.S. after months of barring foreign visitors, although it likely won’t happen anytime soon, coronavirus response coordinator Jeff Zients told the U.S. Travel and Tourism Advisory Board. The “new system for international travel” will include contact tracing and may include vaccine requirements, Reuters reports.
Diagnostics maker Cepheid has scored an emergency nod from the FDA for a new version of its rapid COVID-19, flu and RSV molecular test, the company announced. Cepheid’s latest version of the test includes a third gene target to detect SARS-CoV-2, the virus that causes COVID-19, which is designed to “meet the challenge of future viral mutations.”
UPDATED: Wednesday, September 15 at 9:30 a.m.
As the fast-spreading delta variant continues to wreak havoc, the U.S. is stocking up on monoclonal antibody treatments from Eli Lilly and Regeneron to weather the storm. The U.S. will buy 388,000 doses of Lilly’s etesevimab to pair with already purchased stock of bamlanivimab in a deal worth roughly $330 million. Meanwhile, the nation will snap up 1.4 million doses of Regeneron’s cocktail, REGN-COV, in a deal worth nearly $3 billion.
The FDA has released a draft agenda ahead of its meeting on Friday to discuss Pfizer and BioNTech’s application for a vaccine booster. On the agenda, one of the agency’s top vaccine experts, Marion Gruber, Ph.D., is slated to speak following the release of a co-authored paper that refuted the need for boosters. Israeli officials will also join the discussion to present real-world data from the country’s booster program.
President Joe Biden plans to meet with the CEOs of some of America’s largest corporations in an effort to push the administration’s recent nationwide vaccine mandate. The president will appear alongside the chiefs of Microsoft, Disney and Walgreens, among others.
Cuba is asking the World Health Organization to approve its three locally made vaccines—Abdala, Soberana-2 and Soberana Plus—despite criticism that the shots’ trial data has yet to be peer reviewed, Reuters reports, citing an official with the state-run company in charge of producing them.
Most of the U.S.’s largest colleges and universities are not requiring returning students to get vaccinated, although that hasn’t stopped them from offering lucrative prizes for those who do get inoculated, The Associated Press reports. An analysis found that 26 of the country’s 50 largest public campuses are not requiring vaccines, many of those in states that have outright banned the rules.
Following Britain’s decision to nix its supply contract with French pharma Valneva worth roughly 100 million doses, the UK’s top health secretary said it was clear the shot wouldn’t be granted authorization. However, a French government official told Reuters that discussions between the company and the UK are still ongoing and advanced.
UPDATED: Tuesday, September 14 at 2:55 p.m.
A World Health Organization (WHO)-backed vaccine hub in South Africa is angling to produce Moderna’s vaccine for the continent, although the project has stalled amid lagging discussions with the company, Reuters reports, citing a senior WHO official. The tech transfer hub in South Africa, set up in June, has been tasked with developing the complicated mRNA jab, although it hasn’t struck a deal with the company yet.
RedHill Biopharma’s experimental COVID-19 treatment, the SK2 inhibitor opaganib, has failed to help severely ill patients in a late-stage trial. The primary endpoint of the study is the proportion of patients breathing room air without oxygen support after two weeks, but opaganib failed to hit statistical significance in this group. Story
President Joe Biden’s nationwide vaccine mandate for federal workers and employees at large companies was expected to cause an uproar from Republican challengers. Now, Arizona has launched the first lawsuit over the White House’s order issued last week, claiming the administration is “flouting our laws and precedents to push their radical agenda," according to the state’s Attorney General Mark Brnovich.
Greece has taken stringent measures against its unvaccinated residents, banning them from entering indoor venues and requiring regular testing for employees who decide to forgo the jabs, the New York Times reports.
UPDATED: Tuesday, September 14 at 9:30 a.m.
Emergent BioSolutions, after hitting multiple snags over its production of Johnson & Johnson’s single-shot vaccine in Baltimore, has now signed a five-year deal to produce Providence Therapeutics’ vaccine candidate. The deal’s value is $90 million, Emergent says.
German mRNA developer CureVac has cancelled manufacturing pacts with two of its partners, months after the company’s vaccine posted disappointing late-stage trial results. The company will axe its deals with Switzerland’s Celonic Group and Germany’s Wacker, but its partnerships with Bayer and Fareva will remain intact, a company spokesperson told Reuters.
Britain will begin giving booster shots to health-care workers, people aged 50 and older and those who are vulnerable to the virus, totaling roughly 30 million people, The Washington Post reports. The country will begin rolling out a full dose of Pfizer's jab and a half dose of Moderna's as boosters.
Cuba will begin immunizing its children as young as 2, making it the first country to expand eligibility to the group, The New York Times reports. So far, many countries have limited the shots to kids as young as 12, although China and the United Arab Emirates have moved their eligibility down to 3-year-olds. The young kids will be vaccinated with the country’s own Soberana 2 and Soberana Plus vaccines.
UPDATED: Monday, September 13 at 4:00 p.m.
Tensions are mounting between the White House and the CDC over the administration’s plan to roll out booster shots to a wide swath of Americans as early as next week, Politico reports. The agency has clashed with officials from the Biden administration’s task force and the FDA for withholding data considered central to the effort, the publication reports.
Merck could score an FDA nod for its highly anticipated oral antiviral molnupiravir before the end of the year, Chief Executive Officer Robert Davis said at Morgan Stanley's healthcare conference. The drug’s late-stage clinical trial program, which is testing how well molnupiravir keeps people from developing severe disease, “is enrolling well,” Davis said.
Britain is likely to start offering vaccines to those as young as 12 years old after the nation’s top health officials recommended the jabs to keep the country’s kids in school, Reuters reports. The country would join the U.S., Israel and a handful of European countries to offer the jabs to younger children, according to the report.
UPDATED: Monday, September 13 at 11:15 a.m.
Canada's Providence Therapeutics has enlisted China's Everest Medicines to produce and market the company’s mRNA COVID-19 vaccine candidate. Everest would sell the shot in China and other countries in Asia. China has yet to approve an mRNA vaccine, opting for shots from state-run Sinovac and Sinopharm. Four other mRNA candidates are being tested in China, including the Pfizer/BioNTech shot and three domestic candidates.
The U.K. has cancelled a contract for COVID-19 vaccines with French company Valneva, which has yet to secure approval for its shot. In an agreement made early this year, the company was set to provide 100 million vaccine doses from its manufacturing site in Scotland. But the U.K. has charged Valneva with an undisclosed breach of contract.
COVID-19 vaccine boosters are not needed at this time for the general public, said an expert group of U.S. and international scientists in The Lancet. The expert group, which included scientists from the FDA and the World Health Organization, concluded that while protection against mild cases of the disease wanes over time, it remains more durable against severe cases. The report comes as the Biden administration says its plans to offer shots to the general public. An FDA advisory group meets Friday to discuss booster data.
UPDATED: Friday, September 10 at 2:38 p.m.
In a large new study analyzing more than 600,000 virus cases from 13 states, researchers concluded that unvaccinated Americans are more likely to catch the virus and be hospitalized or die than those who are vaccinated, The New York Times reports. Unvaccinated people are 4.5 times more likely to get infected, 10 times more likely to be hospitalized and 11 times more likely to die, the CDC says.
The CDC also released real-world data showing that Moderna's shot is moderately more effective than Pfizer and Johnson & Johnson vaccines at preventing hospitalizations, according to The Washington Post.
UPDATED: Friday, September 10 at 9:25 a.m.
President Joe Biden has ordered employers with more than 100 workers to mandate vaccinations or require weekly testing for the unvaccinated, The Washington Post reports. The move, which Republican governors are already resisting, will impact roughly 80 million Americans.
BioNTech is gearing up to ask global regulators to approve the company’s Pfizer-partnered vaccine for kids as young as 5 years old, executives told German news site Der Spiegel. The company is preparing to launch the jabs, which includes manufacturing smaller pediatric doses, BioNTech’s top medical officer Oezlem Tuereci said. The FDA issued a release on Friday saying it'll follow the science on vaccines in kids.
Three of the nation’s largest retailers—Amazon, Walmart and Kroger—will now offer rapid, at-home COVID tests at-cost for three months as part of the White House’s revamped plan to tackle the pandemic. The slashed prices will go into effect by the end of the week.
China’s Sinovac is looking to open a vaccine production facility in South Africa that would produce its COVID-19 vaccine, as well as jabs against other diseases, for the African continent, executives said at a news conference. The comments come as Sinovac prepares to launch the South African arm of a late-stage trial studying its shot in young children and adolescents.
After landing a job at the life sciences incubator Flagship Pioneering, Former FDA Commissioner Stephen Hahn will now serve a stint as the interim medical chief at one of the venture firm’s portfolio companies focused on blood collection and COVID-19 diagnostics. Story
UPDATED: Thursday, September 9 at 4:05 p.m.
Moderna is likely to begin testing of a combination COVID-19 and flu vaccine in the next 6-12 months, the company said in an investor conference on Thursday. In response to the news, the company’s shares rose by more than 5%. During the event, the company released other details of pipeline therapies, many of them employing mRNA technology. “We believe this is just the beginning of a new age of information-based medicines,” Moderna CEO Stephane Bancel said.
With England set to roll out COVID-19 booster shots, AstraZeneca CEO Pascal Soriot and R&D chief Mene Pangalos have pushed back, saying a third vaccine dose should not be administered until more data are available. The AZ braintrust agrees that boosters for the most vulnerable make sense but that providing them to the general population is premature. AZ’s data on the protection its vaccine offers is set to be released later this month.
Australia prime minister Scott Morrison faces fresh scrutiny for the country’s slow rollout of COVID vaccines after the government released information on early talks with Pfizer which showed officials were reluctant to quickly secure shots. Australia received doses from Pfizer two months after the United States. While the U.S. population is 53% vaccinated, Australia is at 31%.
UPDATED: Thursday, September 9 at 9:53 a.m.
After riding high on the back of positive data in hospitalized COVID-19 patients, the FDA has denied Humanigen an emergency nod for its cytokine storm-targeting treatment, lenzilumab. According to the drugmaker, the agency has asked for more data, saying it “was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19.” Story
President Joe Biden is expected to call for a global vaccine summit with world leaders to coordinate the global pandemic response and boost vaccine supplies for low-to-middle income nations, the Washington Post reports. Biden is also expected to sign an order requiring all federal employees to be vaccinated, the Post reports. The president is planning to provide an update over the country’s COVID-19 response later in the day.
Roughly 40,000 AstraZeneca doses were tossed in Wales after hitting their expiration date, the BBC reports. A government spokesperson said the limited use of AZ’s shot, given that it’s only authorized for people aged 30 and older, and the availability of other shots led to the expired jabs.
While many companies are allowing some employees to bypass vaccine requirements for medical or religious reasons, United Airlines says it will require that group to take a temporary leave of absence starting next month. The airline said it can’t allow unvaccinated employees to mix with customers and vaccinated colleagues “until we better understand how they might interact.” Those exempt for religious reasons will have to take a voluntary unpaid leave while those with medical reasons will be placed on medical leave.
UPDATED: Wednesday, September 8 at 3:12 p.m.
Regulators in Europe listed Guillain-Barré syndrome as a potential rare side effect for AstraZeneca's COVID-19 vaccine, Reuters reports. The European Medicines Agency believes a causal relationship between the syndrome and the vaccine is "at least a reasonable possibility," according to the news service. So far, there have been 833 documented cases of the nerve disorder out of 592 million AstraZeneca doses administered worldwide. Story
Novavax has kicked off a phase 1/2 study of a combined COVID-19 and flu vaccine. The study will enroll 640 healthy adults ages 50 to 70. To be eligible for the trial, participants must have had a prior COVID-19 case or be fully vaccinated with an authorized shot.
Speaking with The Financial Times, Pfizer's chief scientific officer Philip Dormitzer said the company used the "minimum dose level" for its vaccine that would trigger a response stronger than a natural infection. A higher dose may have risked more side effects, he added.
UPDATED: Wednesday, September 8 at 11:00 a.m.
The Bill & Melinda Gates Foundation will make a $35 million equity investment into Exscientia to bankroll five small-molecule assets into the clinic aimed at treating COVID-19, influenza, Nipah and other viruses that could become the next pandemic. The four-year collaboration includes advancing Exscientia's lead program, a COVID-19 antiviral, into the clinic in the second half of next year. For its part, Exscientia will also put up $35 million toward the project. Story
Moderna has tapped fledgling CDMO National Resilience to manufacture drug substance for its mRNA vaccine at its facility in Mississauga, Ontario. Moderna’s partnership with Resilience, first founded in late 2020, comes after the biotech announced plans to bolster Canada’s own vaccine manufacturing capabilities to better respond to respiratory viruses. The Resilience-made substance will be distributed globally, Moderna said. Story
A third person has died after being vaccinated with a Moderna dose that was part of a batch contaminated with stainless steel particles, although a connection between the tainted shots and the deaths has yet to be determined, Newsweek reports.
South African officials are in talks with Johnson & Johnson to carry out a trial testing a booster shot in the country following another mass trial that inoculated nearly half a million health-care workers, Bloomberg reports. J&J’s trial, which would enroll participants in the previous study, could start as early as October, a study co-lead told the news agency. That would follow another booster shot trial being carried out in South Africa from ImmunityBio.
Florida Gov. Ron DeSantis, after advocating for Regeneron’s monoclonal antibody treatment for over a month, is now adding the cocktails from GlaxoSmithKline and Eli Lilly to the list, Florida Politics reports. DeSantis said Florida could soon expand its use of the antibodies, although critics have charged the governor with promoting the treatments more than vaccines.
UPDATED: Tuesday, September 7 at 3:45 p.m.
AstraZeneca CEO Pascal Soriot said extra booster shots may not be necessary for the general public in Britain just yet, warning that they could even add pressure to the nation’s health-care system, the Telegraph reports. Additional “clinical evidence gathered from real world” will be needed before making an informed decision on a third shot, Soriot said.
White House chief medical adviser Dr. Anthony Fauci confirmed in an interview with CBS that it’s likely only a booster from Pfizer-BioNTech will be available in late September when the White House plans to roll out the extra jabs. However, a third shot of Moderna’s mRNA vaccine “will likely follow soon thereafter," Fauci said. He suggested those who’ve received Moderna’s jab wait for the go ahead to get an extra shot rather than get vaccinated with Pfizer’s booster.
Bristol Myers Squibb is joining other biopharma companies in requiring COVID-19 vaccines among its workforce. The pharma giant will mandate that employees in the U.S. and Puerto Rico get vaccinated by Nov. 1, Reuters reports.
Speaking of boosters, White House Press Secretary Jen Psaki maintained that the Biden administration is “looking forward to implementing” the plan it laid out just weeks ago to roll out the extra shots in late September. Those comments come despite recent New York Times reporting that suggests top U.S. health officials, such as the FDA’s Dr. Janet Woodcock and the CDC’s Dr. Rochelle Walensky, have warned the administration that the agencies may not be able to approve the boosters for the general public in the coming weeks.
Following a surprise surge in COVID testing demand, LumiraDx is scrambling to ramp up production for its antigen test kit designed solely for use in monitoring outbreaks among schools, workplaces and other groups and organizations in real-time. It does so by testing up to five samples at once on LumiraDx’s portable, hand-held analyzer and returning results within about 12 minutes. Story
UPDATED: Tuesday, September 7 at 9:25 a.m.
Japan’s Takeda Pharmaceutical will supply 150 million Novavax doses to the government, once the shot is approved. The news comes as the country halts a growing number of Moderna shots due to contamination concerns. Takeda, which is responsible for importing and distributing Moderna’s shots, previously inked an agreement with Novavax to manufacture and sell its jabs in Japan. The company aims to begin Novavax distribution in early 2022. Story
India’s Hetero Pharma has scored a nod from the country’s regulators to produce generic versions of Roche’s coronavirus treatment, known as tocilizumab, Reuters reports. The company plans to make Roche’s drug, also used to treat arthritis, available by the end of the month under the brand name Tocira.
The European Union’s drug regulator said it’s started evaluating an application from Pfizer and BioNTech for a booster shot of the pair’s vaccine, known as Comirnaty, and expects a decision “within the next few weeks.” The European Medicines Agency said the booster would be for people aged 16 and older six months following their initial series.
The Biden administration has laid out a post-pandemic plan aimed at preparing the nation against “future and potentially catastrophic biological threats, whether naturally-occurring, accidental, or deliberate.” As part of the plan, the White House intends to bolster the U.S.’s medical defenses and public health systems; build a stockpile of equipment and strengthen the nation’s supply chain; and additional training about infectious-disease threats, according to a release.
Mixing two doses of China’s Sinovac shot with a booster from CanSinoBIO produced a stronger antibody response when compared with a third booster using the same Sionvac jab, according to a study published in medRxiv that hasn’t been peer reviewed. The third CanSino booster produced a 78-fold increase in virus-targeting antibodies on average two weeks later compared with a 15.2-fold jump with a third Sinovac shot.
UPDATED: Friday, September 3 at 9:25 a.m.
The European Union’s drug regulator is reviewing whether there’s a link between Pfizer and BioNTech’s vaccine and a rare condition known as multisystem inflammatory syndrome (MIS). There has been one reported case in a 17-year-old boy in Denmark who has since recovered. The agency is also reviewing whether Johnson & Johnson’s jab carries a risk of a rare blood clotting condition separate from the cases reported earlier this year.
Just days after U.S. officials gave Eli Lilly the green light to resume shipping its antibody cocktail to a handful of states, they’re now expanding that access to the entire country. Shipments of Lilly’s treatment, a combination of bamlanivimab and etesevimab, were halted after officials said it failed to protect against a set of troublesome virus variants. Since delta has become the dominant variant, there’s been a decrease in the strains that were resistant to Lilly’s treatment, HHS said.
AstraZeneca has struck an agreement with the European Union over the delivery of 200 million outstanding vaccine deliveries, ending a months-long legal battle between the bloc and the U.K.-based drugmaker. Under the deal, AZ will send 60 million doses by the end of September, 75 million by the end of 2021 and 65 million by the end of the first quarter next year, according to the company.
The U.S. will funnel $2.7 billion to bolster vaccine manufacturing in an attempt to become the “arsenal of vaccines for the world.” While it’s unclear where the money will be directed, the White House’s COVID-response team said it would be used to bolster production of lipids, bioreactor bags, tubing, needles and syringes, the New York Times reports, citing top officials.
Pfizer is planning to roll out new, smaller packages for its BioNTech-partnered vaccine that could reduce waste and expand access in rural areas, CBS News reports. The CDC expects the new packaging to become available by October, according to a document the agency sent immunizers last month.
UPDATED: Thursday, September 2 at 4:05 p.m.
GlaxoSmithKline has told Fierce Pharma that it will now require its employees in the United States to be fully vaccinated against COVID-19. The rule also will apply to consultants and visitors. The rules will be applied where allowed by law and where vaccine supply is readily available. The policy will be implemented at U.S. sites over the next few weeks.
In a small study, researchers at the University of Virginia have found that the COVID-19 vaccine from Pfizer-BioNTech produces fewer antibodies than the Moderna shot in the elderly. The study, which included 167 people who had received two doses of either vaccine, showed that antibody durability varied more significantly in the elderly than among younger recipients. Researchers warned against drawing conclusions from a study of this size.
A real-world study in Bangladesh shows that the use of masks can slow the spread of COVID-19. The study of more than 340,000 people also showed that surgical masks offered more protection than cloth masks.
Canada will donate more than 1.3 million doses of the AstraZeneca COVID-19 vaccine to three African countries through the COVAX worldwide relief effort, GAVI said on Thursday. Nigeria, Kenya and Niger will be the recipients.
South Africa has received only 4.2 million vaccines from Johnson & Johnson, or just 14% of the 31.2 million doses it has ordered from the company. The slow supply helps account for the lagging vaccination rate of the country (15%), the Mail & Guardian reports.
Throughout the pandemic, COVID-19 test-maker Cue Health has racked up hundreds of millions in venture capital. The company now will go public with an IPO that could bring in as much as $100 million more. Cue Health, which filed with the SEC on Wednesday, is developing diagnostic tools for other disorders as well. Story
UPDATED: Thursday, September 2 at 10:26 a.m.
An outside FDA advisory panel will meet on Sept. 17 to discuss the need for an additional booster shot and, specifically, Pfizer and BioNTech’s application for the extra jab, according to a statement. The meeting will come after the Biden administration laid out its plan for booster shots to start later this month, a move some have criticized for coming before approval from federal regulators. Story
Moderna has asked the FDA to authorize a booster shot of its mRNA vaccine, saying a third dose given six months after someone’s first two jabs significantly boosted virus-fighting antibodies, according to a statement. Moderna’s application comes just after Pfizer also applied for an extra jab. The mRNA biotech said it will file additional applications with European regulators in the coming days.
Following mounting criticism, Johnson & Johnson doses produced by Aspen Pharmacare’s plant in South Africa will no longer be shipped to Europe, and doses already shipped and sitting in warehouses will be returned, The Associated Press reports citing officials with the African Union. Additionally, Aspen’s agreement with J&J will move from a contract deal to a licensing agreement, similar to the deal between AstraZeneca and India’s Serum Institute. Story
People who are vaccinated but still experience a breakthrough infection are roughly half as likely to experience long COVID versus those who are unvaccinated, the New York Times reports, citing a new study in the medical journal The Lancet. The study was based on answers from 1.2 million people who received either Pfizer, Moderna or AstraZeneca’s vaccine and logged their symptoms in a mobile app.
UPDATED: Wednesday, September 1 at 4:07 p.m.
The U.S. has tossed at least 15.1 million doses of vaccines since March 1, although that figure is still likely an undercount, NBC News reports, citing government data. Four major pharmacy chains reported at least 1 million wasted doses each, with Walgreens reporting the most waste.
A jab of Moderna may keep you out of the hospital, but a jab of Maderna might land you in jail. An Illinois woman is finding that out the hard way after officials in Hawaii busted the vacationer trying to use a fake COVID-19 vaccine card, HawaiiNewsNow reports. How did they know it was fraudulent? A blatant typo that misspelled Moderna as “Maderna.”
Speaking of unvaccinated travelers, CDC Director Dr. Rochelle Walensky is advising those without jabs to forgo travel over the upcoming Labor Day weekend, CNBC reports. Walensky’s warning comes amid another wave of infections in the U.S., which is reporting a weekly average of roughly 129,418 daily cases.
Mesoblast has been put on blast by the FDA yet again after the agency requested another trial for its failed, Novartis-backed COVID-19 respiratory treatment. The Australian cell therapy biotech will have to conduct another study of remestemcel-L to have a shot at an emergency use authorization. It's another blow to Novartis, which doled out $50 million upfront and more than $1 billion in biobucks for a global license to the drug for acute respiratory distress syndrome. Story
COVID-19 wasn’t even in the picture when mRNA was developed as a new medicine, but with the regulatory runway cleared, biotechs that have been working on the tech for years are ready for liftoff. About a dozen companies besides Moderna and BioNTech are working on mRNA vaccines and therapeutics for a range of diseases from flu to cystic fibrosis. Here’s a look at what’s next in the pipeline. Story
UPDATED: Wednesday, September 1 at 8:50 a.m.
Pfizer has started dosing participants in a phase 2/3 study for its at-home oral antiviral pill to combat COVID-19 in non-hospitalized patients who are not at risk of severe disease or death, according to the company. Pfizer’s pill, a protease inhibitor, is designed to block the activity of the main protease enzyme that the coronavirus needs to replicate.
Merck and partner Ridgeback Biotherapeutics have started their own phase 3 study testing how well their oral coronavirus pill, known as molnupiravir, works at preventing an infection after someone is exposed to the virus. The pair are already testing the drug in a late-stage trial to determine how well it keeps people with mild to moderate symptoms and at risk of severe disease out of the hospital.
Japan has identified another batch of Moderna doses potentially contaminated with foreign substances, the fourth time in less than a week, Reuters reports. The vial, which reportedly had several black particles in it, was detected in the Kanagawa prefecture, just south of Tokyo. The rest of the lot that contained the vial has been placed on hold.
Belgium-based ExeVir has launched an early-phase study for its antibody, known as XVR011, according to a statement. The 27-person phase 1B study will evaluate three different dosages of the treatment administered intravenously in patients hospitalized as a result of mild to moderate COVID-19, with the aim to allow a more rapid recovery, the company said.
UPDATED: Tuesday, August 31 at 3:55 p.m.
The U.S. has already administered nearly 1 million COVID-19 boosters following the FDA’s decision to authorize the extra jabs for immunocompromised people less than three weeks ago, CNBC reports, citing CDC data. There’s no way to tell whether the 955,000 fully vaccinated people who’ve received a booster were eligible, however. Federal health officials are currently debating whether an extra shot is needed for the general population.
Two longstanding FDA leaders who were pivotal in the U.S.'s effort to authorize COVID-19 vaccines will leave the agency just as it faces key questions over booster shots. FDA Office of Vaccines Research and Review Director Marion Gruber, Ph.D. and Deputy Director Phillip Krause, M.D. will depart the FDA after spending decades with the agency. Story
London-based diagnostics developer DnaNudge, which produces a coronavirus PCR test that can be performed outside of a lab and takes less than two hours from sample collection to results, has received a $60 million series A funding bump led by Ventura Capital, an investment company. The company is aiming to expanding its PCR test beyond Europe, specifically eyeing new markets in the U.S. and Japan. Story
UPDATED: Tuesday, August 31 at 9:25 a.m.
In a study involving 2,500 hospital workers in Belgium, the Moderna vaccine prompted more than double the amount of antibody production when compared with the mRNA vaccine from Pfizer-BioNTech, according to results published in the medical journal JAMA. The results may differ because Moderna’s jab uses 100 micrograms of active ingredient versus Pfizer’s 30 micrograms, and Moderna’s jab has a longer interval between doses, Bloomberg reports.
GSK and SK biosciences are moving their adjuvanted COVID-19 vaccine, GBP510, into a phase 3 trial that'll test the shot against a rival from AstraZeneca and Oxford University, the companies announced. GSK’s top health officer noted that there remains a need for an “accessible and affordable” vaccine. If approved, the pair will work to deliver the potential vaccine at scale through the global vaccine sharing facility COVAX.
AstraZeneca will require its U.S.-based workers to get vaccinated against COVID-19 if returning to the workplace or visiting customers, a spokesperson told The New York Times. The England-based drugmaker said the policy will also apply to its subsidiary Alexion Pharmaceuticals, headquartered in Boston.
Researchers are monitoring a new coronavirus variant that carries a similar set of concerning mutations as other strains, including alpha, beta and gamma, CNN reports. However, officials with the World Health Organization say they don’t believe the new variant, known as C.1.2, is widely spreading.
Despite disappointing late-stage results that landed CureVac’s mRNA vaccine behind its rivals, the German biotech still plans to submit the shot to European regulators by the end of September. CureVac’s shot, dubbed CVnCoV, was just 48% effective against the virus in clinical trials.
UPDATED: Monday, August 30 at 3:59 p.m.
New data confirm that the Pfizer-BioNTech and Moderna mRNA vaccines carry a small risk of a heart condition known as myocarditis, mostly among adolescent boys and young men. The side effect is mostly mild and temporary, according to a presentation delivered during a CDC advisory committee meeting. The agency's experts maintained that the shot’s benefits still greatly outweigh potential risks, The New York Times reports.
Meanwhile, a CDC presentation published ahead of the vaccine advisory committee meeting suggests that there’s limited data available to assess whether a booster is needed for the general population, despite the White House’s push to roll out extra shots starting next month, CNBC reports. The panel is meeting to decide whether a booster would be needed for all eligible Americans.
The U.S. Department of Education warned five states that it’s investigating whether their statewide mask mandate bans violate students’ civil rights, NPR reports. In a letter sent to education officials in Iowa, Oklahoma, South Carolina, Tennessee and Utah, the agency said it was concerned the bans don’t account for students with disabilities who may be at greater risk from the disease.
Mayo Clinic and nference kicked off 2021 by expanding their data analytics-based research collaboration to include COVID-19 treatments. Now, the pair have produced the first AI-powered studies examining the use of monoclonal antibodies in patients with an elevated risk of hospitalization for the virus due to comorbidities such as hypertension, obesity, diabetes and chronic lung disease. Story
UPDATED: Monday, August 30 at 9:20 a.m.
The U.S. will resume using Eli Lilly’s antibody cocktail, a combination of bamlanivimab and etesevimab, in certain states after it paused the treatment’s rollout nationwide in late June. The U.S. halted the combo's use after officials said it failed to protect against a set of troublesome virus variants. Now, states where those variants make up less than 5% of all cases can resume using Lilly’s treatment, according to the HHS.
Japan has suspended the use of another million Moderna doses following contamination concerns, bringing the nation’s total hold to 2.6 million doses, Reuters reports. Japan first suspended 1.63 million doses after tiny substances were found in the vials.
The National Institutes of Health (NIH) plan to launch a phase 2 study examining the antibody response following a third shot of either the Pfizer-BioNTech or Moderna vaccine in people with a preexisting autoimmune disorder. Roughly 8% of Americans have a reported autoimmune condition, such as multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus and systemic sclerosis, according to the NIH. The study will also try to determine whether pausing immunosuppressive therapy helps trigger a greater antibody response.
The European Union is set to encourage member states to add additional travel restrictions on Americans as U.S. infections and hospitalizations make a rebound, The New York Times reports. Europe has largely welcomed U.S. travelers over the summer months to aid its battered tourism industry, but America’s refusal to admit European travelers has frustrated the bloc, according to the report.
A Japanese minister in charge of the nation's vaccine rollout said it's considering mixing Pfizer-BioNTech and Moderna doses with its currently deployed AstraZeneca jabs to speed up its rollout, the Japan Times reports. Japan would join other countries that allow for mixed vaccines, such as France, Canada and Germany, despite limited evidence for the tactic. However, the country’s top spokesperson said in response that there was not enough data to support the method.
UPDATED: Friday, August 27 at 10:25 a.m.
A contaminant reportedly found in vials of Moderna’s vaccines in Japan appears to be a metallic particle, according to reports from Japanese broadcaster NHK, citing health ministry officials. The news comes after Japan suspended the use of 1.63 million doses which had been distributed to 863 vaccination centers in the country.
Meanwhile, Spanish CDMO Rovi Laboratories said Moderna’s vaccine contamination was limited to just one product lot bound for Japan. The company added it is investigating the issue and is in communication with health authorities.
China’s Chongqing Zhifei Biological Products reported that its vaccine was 81.76% effective against COVID-19 of any severity in late-stage testing, although the company hasn’t disclosed full details, Reuters reports. The company noted that the jab was 7.54% effective against the highly transmissible delta variant, but it didn’t disclose how many cases were reported in the trials.
India, which was once hit with a wave of infections as its vaccination campaign lagged behind other countries, has now administered at least one dose to more than half of its population, the New York Times reports. Vaccinations in India are also expected to ramp up once the country starts using Zydus Cadila’s DNA-based shot in October, according to the report.
BioNTech, on the heels of its COVID-19 success, is evaluating Rwanda and Senegal as potential manufacturing sites for what would be the world’s first mRNA vaccines against malaria and tuberculosis. The sites would provide “end-to-end vaccine supply solutions on the African continent.” Story
UPDATED: Thursday, August 26 at 3:50 p.m.
Medical device company BD and partner Scanwell Health scored the FDA’ first greenlight for an at-home COVID-19 test that delivers results through the user’s smartphone. The Veritor rapid antigen test operates similar to a home pregnancy test and comes as more students and employees begin returning to classrooms and the workplace. Story
AstraZeneca and partner rHealth say a test they developed to measure someone’s blood platelet count at the point of care had comparable accuracy to current gold-standard testing method. The test could benefit AZ’s vaccine, which was tied to a rare blood disorder that leads to blood clots but also a sharp decrease in the number of platelets, which can in turn lead to an increase in bruising and bleeding. Story
The World Health Organization-backed COVAX program plans to ship out 100 million doses of vaccines from China’s Sinopharm and Sinovac by the end of September, the first time the jabs have been delivered under the global vaccine sharing facility, Reuters reports. According to an internal document, the shots will be spread out among 60 countries, mostly in Africa. However, some countries have turned down the doses, saying they don't know how well they work against the delta variant.
Months after the U.S. pulled funding for Inovio’s DNA vaccine’s clinical trial program, the company says it’s now taking its phase 3 trial to sunny Brazil. The company received authorization from Brazilian health officials to run the study, called Innovate, which will test the company’s vaccine INO-4800, according to a Thursday statement. Story
Drugstore chain Rite Aid, in partnership with the Department of Health and Human Services and BioReference Labs, is offering free testing to all of New York’s K-12 public school students to kick off the new school year, according to a statement.
UPDATED: Thursday, August 26 at 9:25 a.m.
Moderna, which has so far managed to dodge significant manufacturing hiccups with its COVID-19 vaccine, now says it's investigating a vaccine batch sent to Japan. The company has received "several complaints of particulate matter" in vials of the vaccine, a Moderna spokesperson said via email. Kyodo News first reported that Moderna's vaccine partner in Japan, Takeda, has suspended the use of 1.63 million doses. Story
Pfizer and German partner BioNTech plan to team up with Brazil’s Eurofarma Laboratórios to manufacture doses of the pair’s mRNA vaccine for Latin America. Eurofarma will be tasked with manufacturing finished doses with drug product sourced from the U.S., the drugmakers said. At full capacity, Eurofarma will be able to turn out more than 100 million doses annually.
The Pfizer-BioNTech vaccine has been linked to increased rates of a rare heart inflammation condition, known as myocarditis. But it turns out, people who are naturally infected with COVID-19 are at a far greater risk for the condition than vaccinated people, according to a study published in the New England Journal of Medicine. While just 2.7 extra myocarditis cases were reported among the vaccinated group out of 100,000 people, that figure shot up to 11 for those who were naturally infected.
Illinois Gov. J.B. Pritzker is expected to require all of the state’s teachers, including college educators, to get vaccinated against COVID-19, the Chicago Tribune reports. The governor is also expected to require masks inside for people age 2 and older. The news comes just a day after Chicago Mayor Lori Lightfoot ordered all of the city’s employees to be fully vaccinated by Oct. 15.
NRx Pharmaceuticals tapped Cardinal Health to provide third party logistics and distribution for Zyesami, NRx's potential treatment for hospitalized COVID-19 patients. The company is awaiting an emergency nod for the cytokine-storm targeting treatment after submitting data to the FDA in May.
UPDATED: Wednesday, August 25 at 1:45 p.m.
Novo Nordisk is requiring workers at its U.S. headquarters in Plainsboro, NJ, plus those at its Washington, D.C., office to "provide full proof of vaccination," a spokesperson said. At other U.S. sites, the company is encouraging vaccinations and is requiring masks regardless of vaccination status.
In her first week on the job, New York Gov. Kathy Hochul said the state has had about 12,000 more COVID-19 deaths than previously disclosed, The Associated Press reports. About 55,400 New Yorkers have died from the virus based on death certificate data, Hochul said, compared with about 43,400 that former governor Andrew Cuomo's office had disclosed.
While many companies are mandating vaccines, Delta Air Lines is going another route. The company says that starting on Nov. 1, employees who aren't vaccinated will have to pay an extra $200 per month in health insurance premiums, CNBC reports. Starting Sept.12, unvaccinated employees will need to get weekly tests in areas of high transmission.
The top mRNA vaccine players provided updates on their FDA applications on Wednesday. Moderna has completed its FDA Biologics License Application for a full approval, and Pfizer has started a rolling submission for a booster dose.
UPDATED: Wednesday, August 25 at 9:15 a.m.
Johnson & Johnson found a second jab serving as a booster for its single-shot vaccine generated a “nine-fold” spike in antibodies compared with the four weeks following a single dose, citing early-stage clinical trial results. The drugmaker is in talks with regulators in the U.S. and Europe over a boosting strategy for its authorized vaccine.
Fledgling Brii Biosciences is touting promising phase 2/3 clinical trial data showing its antibody cocktail slashes the chances of hospitalization and death in high-risk outpatients by 78%. Researchers are still following up with the patients in the NIH-partnered study and analyzing questions such as whether the delay between the onset of symptoms and the start of treatment affects outcomes. Brii has not yet shared detailed safety data. Story
In anticipation of emerging virus variants, Spain has inked a deal with Sanofi and GlaxoSmithKline for 500,000 doses of the pair’s protein-based vaccine for early 2022, although the jab hasn’t scored a regulatory nod yet, European news agency The Local reports. Sanofi and GSK started late-stage testing in May and hope to score approval by year’s end.
The EU’s drug regulator has approved additional manufacturing sites to help boost supply for the mRNA vaccines from Pfizer-BioNTech and Moderna, according to a statement. A Delpharm-owned facility in France can now conduct fill-finish duties for Pfizer, while a Catalent plant in India can do the same for Moderna, the European Medicines Agency said.
It’s likely that a variant will emerge one day that escapes the protection afforded by Pfizer’s BioNTech-partnered vaccine, although the company is keeping a close eye on the mutations, CEO Albert Bourla told Fox News. Pfizer’s goal is to develop a new jab within three months once a vaccine-escaping variant arises.
UPDATED: Tuesday, August 24 at 2:18 p.m.
Gearing up for a post-pandemic future, Samsung Group is laying out a whopping $205 billion for manufacturing investments. The cash will help Samsung "prepare for economic and societal changes beyond the post-COVID-19 era," the company said in a statement. Samsung's CDMO and biosimilar groups will benefit from the investment, among other businesses. Story
Thanks to new product launches and tuck-in acquisitions, Medtronic posted sales growth of nearly 20% in its latest quarterly earnings report. CFO Karen Parkhill told analysts the company noticed a slowdown in certain businesses starting in late July. Overall during the quarter, Medtronic generated nearly $8 billion. Story
During weeks when the delta variant spread heavily in the U.S., vaccine effectiveness fell to 66%—from about 90%—in more than 4,000 frontline healthcare workers, CDC researchers found. Most of the healthcare workers had received an mRNA vaccine from either Pfizer or Moderna.
After Pfizer's full COVID-19 vaccine approval, President Joe Biden is calling on employers to require vaccines. Many in the pharma industry had already announced vaccine mandates before the president's plea.
UPDATED: Tuesday, August 24 at 9:10 a.m.
A day after Pfizer and its partner BioNTech won the FDA’s first full COVID-19 vaccine approval, leading infectious disease expert Dr. Anthony Fauci says more approvals could be coming soon. Speaking with MSNBC, Fauci said vaccines from Moderna and Johnson & Johnson could score approvals within weeks. Meanwhile, FDA nods for younger children under age 12 could come by the fall or early winter, Fauci told the “Today” show.
India’s first mRNA-based vaccine from Gennova Biopharmaceuticals was safe and effective in an early-stage trial, the Indian government reported. The jab will now be funneled through a phase 2 trial, which will test Gennova’s vaccine at roughly 10 to 15 sites as the company simultaneously scales up its manufacturing capabilities, according to a statement.
Israel, one of the first countries to roll out Pfizer-BioNTech booster shots to its general population, is seeing signs that the extra jab is thwarting the virus just a month in, Reuters reports, citing officials and scientists. The country has administered over a million boosters to people over 60.
A senior executive with China’s Sinopharm told state media that the country should start rolling out booster shots once more people receive their initial jabs. People who are over 60 and essential workers, like those in restaurants and delivery, should be given priority.
Hawaii is urging travelers to stay away from the islands as the state faces a surge of infections, driven by the delta variant. Gov. David Ige said “it’s not a good time to travel” to Hawaii as local leaders impose tighter restrictions on social gathering, forcing sporting events to go without crowds and cancelling upcoming concerts.
UPDATED: Monday, August 23 at 3:45 p.m.
In a historic decision that comes weeks ahead of its expected Labor Day deadline, the U.S. FDA has awarded its first full approval for a COVID-19 vaccine to Pfizer and its German partner BioNTech. The vaccine, now approved for people aged 16 and older, will remain under an emergency nod for adolescents aged 12 to 15, the FDA said in a statement on Monday. Story
As expected, a trickle of stricter vaccine mandates were issued shortly following the FDA’s full approval of the Pfizer-BioNTech jab. The Pentagon will expedite its forthcoming requirement for all U.S. troops now that the agency has given Pfizer an official nod, the Associated Press reports, citing a department spokesperson. Meanwhile, New York City will require all of its public school workers to get vaccinated, eliminating the option for weekly testing, Mayor Bill de Blasio announced.
“You are not a horse. You are not a cow,” read a now-viral tweet from the FDA over the weekend. The message? People shouldn’t use ivermectin tablets, an anti-parasite medicine commonly used in livestock, as a treatment for COVID-19. According to the agency, there have been multiple reports of people who’ve been hospitalized after self medicating with the version intended for horses.
As demand for COVID-19 testing waned during the spring and early summer, Abbott told factory workers to shred millions of paper testing cards that it thought would never sell, according to an investigation by The New York Times. Now, as parents, teachers and students plan their return to the classroom or workplace amid the rapid rise of the delta variant, those tests are back in demand. Story
UPDATED: Monday, August 23 at 9:20 a.m.
Moderna has become the latest drugmaker to require all of its workers in the U.S. to get fully vaccinated against COVID-19 starting Oct. 1, according to a statement. Moderna’s move follows similar mandates from other pandemic shot makers, Johnson & Johnson and Pfizer. Story
India has cleared Zydus Cadila’s DNA vaccine, known as ZyCoV-D, for emergency use, making it the world’s first against COVID-19. The needle-free vaccine is administered in three doses through a device called Tropis, which delivers the shot through the skin, Quartz reports. Zydus’ vaccine will become India’s second authorized home-grown jab, following Bharat Biotech’s Covaxin.
Preparing for its own booster-shot needs, the U.K. has ordered 35 million more Pfizer-BioNTech vaccine doses for delivery during the second half of next year, Reuters reports. Meanwhile, the U.K. will also begin offering thousands of free daily antibody tests to people who test positive for the first time. The new program is designed to estimate the amount of vaccinated or previously infected people who still catch the virus.
The U.S. FDA is aiming to issue a full approval for Pfizer’s BioNTech-partnered vaccine by Monday, faster than its previously expected Labor Day deadline, the New York Times reports. U.S. officials are hoping the first full approval for a COVID-19 jab will lead to more vaccinations among those who were previously hesitant under an emergency nod.
LumiraDx has had to dramatically cut back its plans for going public, following a steep drop in demand for COVID-19 screening, slashing $2 billion off the value of a planned reverse merger with a special purpose acquisition company, or SPAC. Story
UPDATED: Friday, August 20 at 9:08 a.m.
Roche and Regeneron’s antibody cocktail, dubbed Ronapreve overseas and REGEN-COV in the U.S., scored a nod from the U.K.’s drug regulator as the first monoclonal antibody combo to treat and prevent acute COVID and reduce hospitalizations. Doses of the treatment, which can be taken as an injection or infusion, will start rolling out doses immediately, said British health secretary Sajid David.
AstraZeneca, after enduring numerous challenges with its vaccine, has caught a break. The drugmaker has shown its long-acting antibody cocktail cuts the risk of symptomatic coronavirus infection by 77% in a late-stage study, teeing the company up to apply for an emergency approval. There were no cases of severe COVID-19 or deaths related to the virus in the AZD7442 arm. Three people on placebo developed severe COVID-19, and two died. Story
The FDA and CDC are looking into reports that Moderna's mRNA-based shot could be tied to a higher risk of a rare heart condition in younger adults than initially thought, The Washington Post first reported. Canadian data suggest Moderna's shot could carry a higher risk of myocarditis for young people than Pfizer and BioNTech's vaccine, especially in men below the age of 30. The U.S. agencies need to do more work before they issue any kind of warning or recommendation, a source close to the matter told the Post.
Changes are underway at Johnson & Johnson. Current CEO Alex Gorsky, who’s been at the company’s helm since 2012, will hand over the reins to veteran and current vice chairman of the executive committee, Joaquin Duato, effective Jan. 3, 2022. Story
A Democratic lawmaker wants the U.S. to redirect 1.3% of its U.S. military spending, or about $9.6 billion, to the global vaccination effort. Wisconsin U.S. Rep. Mark Pocan introduced the COVID Defense Act with the goal of vaccinating an additional 30% of the world’s low-income population by the end of the year.
Texas will stop enforcing the governor’s ban on mask mandates after the state’s Supreme Court ruled that school districts could require the coverings, The New York Times reports. So far, seven schools and 48 school districts have defied Gov. Greg Abbott’s ban on masks, including large cities like Dallas, San Antonio and Houston.
UPDATED: Thursday, August 19 at 3:19 p.m.
Joining a host of other pharma companies, Amgen on Thursday said it'll require vaccines for field and remote staff in the U.S. and Puerto Rico starting Nov. 1. A spokesperson said most of Amgen's workforce is already vaccinated and that the company will make exemptions for "qualifying religious or medical reasons."
Right after the White House said that COVID-19 booster shots would start in the U.S. next month, experts are raising concerns. World Health Organization officials blasted the move, and vaccine experts in the U.S. raised questions about the data supporting the booster strategy. The FDA and CDC have yet to endorse boosters. Story
A "dream" vaccine? That's what researchers at the Duke-NUS Medical School and the National Centre for Infectious Diseases are pursuing. The team found that 2003 SARS survivors who later received the Pfizer-BioNTech mRNA shot against COVID-19 produced antibodies capable of tackling all known pandemic variants, plus other coronaviruses. The scientists are now recruiting SARS survivors to conduct further research on a broadly protective coronavirus vaccine.
UPDATED: Thursday, August 19 at 9:00 a.m.
President Joe Biden will require all nursing home facilities to require vaccinations among employees, or they'll risk losing Medicare and Medicaid funding. The move marks the first time the White House has threatened to withhold federal dollars to push vaccinations, and the first time the president has nearly forced vaccines onto non-government workers.
The World Health Organization and the global health group Unitaid called on Roche to ensure that the limited supply of its arthritis drug Actemra, used to treat severe COVID-19 patients, doesn’t go to only rich nations. Earlier this week, Roche’s Genentech said demand for the drug has skyrocketed over 400%, warning that supplies might not return for weeks to months.
A number of immunologists and vaccinologists are pushing back against the Biden administration’s decision to roll out booster shots beginning next month, arguing that the move is not based on science, Stat News reports. Some of the experts point to other countries with crawling vaccination programs, questioning whether it's moral to administer boosters when other populations don’t yet have access to the jabs.
Meanwhile, a new British study shows that the protection from the Pfizer and AstraZeneca vaccines against the Delta variant drops after three months following a second jab, although the shots still hold up against the troublesome mutation, Reuters reports. The Oxford University study studied more than 3 million swabs and found that Pfizer’s vaccine effectiveness dropped from 85% to 75%, while AstraZeneca’s slid from 68% to 61%.
UPDATED: Wednesday, August 18 at 3:35 p.m.
The U.S. CDC is setting up the Center for Forecasting and Outbreak Analytics to trace new outbreaks and analyze how they might unfold. It'll serve as the "the country’s first government-wide public health forecasting center,” CDC Director Rochelle P. Walensky said in a statement.
While Moderna and Pfizer COVID-19 vaccine recipients are learning details about the United States' booster program, Johnson & Johnson vaccine recipients aren't yet sure when or if they'll need additional shots, health policy expert Leana Wen points out in The Washington Post. She wrote that they "deserve better."
CSL's flu vaccine group Seqirus delivered 130 million flu vaccines globally last year despite pandemic challenges, helping the outfit grow revenues 30% worldwide. The company is getting ready to match its U.S. distribution figures again this season, an exec said. Meanwhile, the company plans to venture into mRNA research, CEO Paul Perreault told analysts. Story
UPDATED: Wednesday, August 18 at 9:15 a.m.
U.S. officials are rolling out early details on COVID-19 booster plans. People who've received two doses of the Pfizer and Moderna shots will be eligible for boosters about eight months after their second dose. Boosters will start on the week of September 20, The Wall Street Journal reports. It isn't yet clear whether Johnson & Johnson vaccine recipients will need boosters, although experts say it's likely they will.
Traveling for the holidays? Expect to wear a face mask if you’re commuting by train, bus or airplane. That’s because the Biden administration plans to extend its face mask requirement for those travelers, as well as people waiting at airports and train stations, through Jan. 18, Reuters reports. The current order was set to expire on Sept. 13.
Texas Gov. Greg Abbott, who has recently rallied against mandatory mask mandates in schools, has tested positive for COVID-19. The governor is fully vaccinated, isolating and receiving Regeneron’s monoclonal antibody treatment, Abbott’s office said in a statement.
A slew of recent studies from the U.S., Israel, Britain and Qatar suggest that the vaccines are still highly effective against severe forms of the disease, although their ability to thwart mild to moderate infections may be waning, The Washington Post reports. Still, the vaccines are working as they should, experts tell the paper.
Canadian province Ontario will offer a third booster jab for its most vulnerable citizens in an effort to provide “an extra layer of protection” against the troublesome delta variant. That will include citizens who are immunocompromised, like organ transplant and cancer patients, as well as older people in high-risk settings, like retirement homes.
UPDATED: Tuesday, August 17 at 3:41 p.m.
Qualigen is calling it quits on its coronavirus antiviral program after the FDA asked for a couple more preclinical studies on its main med, QN-165, before starting human testing. The move, disclosed during a second-quarter earnings report, comes after the company shelled out $3.4 million on the therapy during the second quarter out of a total $4.5 million in R&D expenses. Story
Twitter is rolling out a feature that will make it easier for users to report vaccine misinformation. The move comes weeks after U.S. officials pushed social media giants to do more to remove false info on their platforms, the Verge reports.
Houston will pay $100 to anyone who receives their first shot at a county public health site in an effort to get more shots into arms, Judge Lina Hidalgo announced. The county has earmarked $2.3 million for the program, enough for roughly 23,000 people, the Texas Tribune reports.
UPDATED: Tuesday, August 17 at 11:30 a.m.
The U.S. plans to advise most Americans to receive a booster eight months following their initial vaccine regimen, with third jabs planned for as early as mid-September, The New York Times reports. The move will depend on the FDA’s eventual authorization for an additional shot. It’s thought that Johnson & Johnson recipients will also need an extra jab, but officials are awaiting results of a trial testing two doses of the vaccine. Story
The U.K. has authorized Moderna’s jab for adolescents aged 12 to 17, a month after the EU issued a similar ruling. Meanwhile, the company is awaiting the FDA’s nod for the age group in the U.S. Moderna also announced that it updated its supply agreement with Canada, proffering up to 105 million doses of its vaccine or, if approved, its booster through 2024.
Gritstone bio unveiled a new funding agreement with the Coalition for Epidemic Preparedness Innovations for its next-generation COVID-19 vaccines worth up to $20.6 million. Gritstone’s vaccine program, known as Coral, uses self amplifying mRNA technology to deliver multiple antigens to target troublesome virus variants.
Roche's Genentech warned that the "unprecedented" surge in demand for its arthritis drug Actemra, used to treat severely ill COVID-19 patients, has driven a global shortage that could last for months if the pandemic continues at its current pace. The latest pandemic wave has catapulted Actemra demand "well over" 400% compared with pre-COVID levels just in the last two weeks alone, the company said. Story
Johnson & Johnson is exporting millions of its single-shot vaccines from fill-finish manufacturers in South Africa to countries in Europe, even as Africa’s vaccination efforts lag behind, The New York Times reports, citing company and government officials. That’s largely thanks to a stipulation in J&J’s contract with South Africa, which blocks the government from imposing export restrictions on the drugmaker.
UPDATED: Monday, August 16 at 3:55 p.m.
Pfizer and partner BioNTech submitted initial data from an early-stage trial to the FDA in a bid to authorize a booster for Americans aged 16 and older, not just those who are immunocompromised. The data shows that a third dose of the pair’s vaccine 8 to 9 months after an initial series elicited significantly higher neutralizing antibodies against the original virus strain, as well as the Beta and Delta variants, according to a press release.
Thermo Fisher Scientific received a new emergency use authorization from the FDA to begin rolling out updated iterations of its mainstay TaqPath molecular tests, which will have the ability to detect a variety of COVID-19 mutations. The prescription-only TaqPath kit was initially granted a green light at the onset of the pandemic. About a year and a half later, the new versions have added targets in eight genes linked to the virus, spanning three genomic regions. Story
Novavax has enlisted a pair of industry heavyweights on the quest to push its recombinant COVID-19 vaccine hopeful across the finish line. The biotech’s new senior vice president of quality assurance, Nasir Egal, Ph.D., joins from Sanofi, while Jim Kelly, Novavax’s new chief financial officer and treasurer, makes the move from Supernus Pharmaceuticals. Story
All New York State healthcare workers will have to get vaccinated against the virus unless they have religious or medical reasons not to, Gov. Andrew Cuomo ordered in a statewide mandate. About 75% of New York’s roughly 450,000 hospital workers are fully vaccinated, according to a statement.
UPDATED: Monday, August 16 at 9:30 a.m.
Johnson & Johnson will require all of its U.S.-based employees and contractors to be fully vaccinated by Oct. 4, although people with medical conditions or other reasons to not be vaccinated may be accommodated, the company said in a statement. J&J’s decision follows similar moves from drugmakers like Gilead Sciences and Pfizer. Story
GlaxoSmithKline and CureVac’s next-generation vaccine, dubbed CV2CoV, generated a stronger immune response in preclinical animal trials compared with CureVac’s first-generation jab, known as CVnCoV, which previously posted a disappointing 47% efficacy in late-stage trials, according to a GSK release. The companies tested their newest jab against the troublesome Beta, Delta and Lambda variants, as well as the original strain, GSK said. The pair plan to initiate a phase 1 trial in the fourth quarter this year.
Florida Gov. Ron DeSantis is expanding the state’s use of mobile clinics to administer Regeneron’s antibody cocktail, a combo of casirivimab and imdevimab, amid a surge in coronavirus hospitalizations in the state. While Regeneron’s drug has shown promise, doctors still stress that taking the vaccine is the greatest defense against the virus, the Washington Post reports.
Merck’s highly anticipated oral treatment molnupiravir is now under a rolling regulatory review in Canada, the company announced. The Ridgeback Biotherapeutics-partnered drug is currently undergoing phase 3 testing in newly infected, high-risk patients.
The CDC officially signed off on the use of a third mRNA booster for immunocompromised Americans, teeing up vaccinations to begin immediately. Among those included in the CDC’s guidelines are patients who've received an organ transplant; patients receiving treatment for solid tumor cancers and blood cancers; stem cell transplant patients; and people with advanced or untreated HIV infection.
UPDATED: Friday, August 13 at 9:05 a.m.
New Orleans and San Francisco will join New York City in requiring proof of vaccination for people who want to enter restaurants, gyms and other indoor venues, Reuters reports. The pair also join the growing split between Democrat and Republican-led states and cities over vaccine and masking policies.
The U.S. FDA authorized a third mRNA booster jab from Moderna or Pfizer for Americans with compromised immune systems, a highly anticipated move that doesn’t encompass the broader population, including the elderly. The new authorization includes organ transplant patients, as well as “those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise," the agency said. CDC advisors are scheduled to meet later in the day to vote on the need for boosters.
The World Health Organization called on all governments to cooperate with their search for the origins of the coronavirus, noting that the mission isn’t “an exercise in attributing blame, finger-pointing or political point-scoring.” The global health agency also called on China to share “vitally important” data surrounding its earliest cases of COVID-19.
After Atea Pharmaceuticals reported early data in June showing its Roche-partnered antiviral can slash the SARS-CoV-2 viral load in hospitalized patients, the company unveiled some changes to that phase 2 program to keep up with the “evolving COVID-19 environment.” Those amendments include changing the phase 2 trial’s primary endpoint from disease progression to virology—namely, the drug’s effect on patients’ viral load. The company is also adding 110 more patients in a new cohort and testing higher doses of the treatment. Story
UPDATED: Thursday, August 12 at 3:30 p.m.
Eli Lilly will require all of its employees in the U.S. and Puerto Rico to get vaccinated against COVID-19 by Nov. 15, the company said. Requests for medical or religious exemptions will be evaluated on a case-by-case basis. Lilly’s requirement follows similar measures from other drugmakers, including Pfizer and Gilead. Story
CDC Director Dr. Rochelle Walensky told The Wall Street Journal she’s “really struggling with how to communicate to people who are worried about politics” as the agency faces backlash for some of its recent guidance. In particular, many are split over the agency’s decision to recommend mask wearing for vaccinated Americans, with some Republican governors defying the guidelines entirely.
Meanwhile, Walenksy confirmed during a White House press briefing that the U.S. FDA is working with Pfizer and Moderna to supply a third booster dose to immunocompromised Americans, including those who've had organ transplants or cancer patients. Infectious disease expert Dr. Anthony Fauci said the Biden administration doesn’t believe boosters are needed for other groups yet, including the elderly.
Evotec has officially kicked off operations at J.POD 1 US in Redmond, Washington, where it’s leveraging "highly intensified" production steps to make biologics more affordably. Its first order of business? Making investigational COVID-19 antibody drugs for the feds. Story
I-Mab’s experimental COVID-19 treatment reduced the mechanical ventilation rate in patients, putting the Chinese biotech in the game with Humanigen in trying to improve treatment options for the sickest patients. Story
As hospitalizations for COVID-19 rise dramatically across the country, hospitals are once again facing looming shortages of beds, ventilators and even nurses. But one new FDA emergency nod for AerosolVE Tent is hoping to solve at least one piece of that conundrum by making a portable tent that can turn any bed, stretcher or operating table into a negative pressure room. It's available to hospitals across the U.S. Story
UPDATED: Thursday, August 12 at 8:55 a.m.
The FDA is set to amend the emergency authorizations for the vaccines from Pfizer-BioNTech and Moderna later this week to allow for immunocompromised adults to receive a third shot as a booster, NBC News reports. The move comes as more evidence mounts showing immunocompromised Americans, about 2.7% of U.S. adults, don’t mount a strong enough immune response following the current two-dose regimen.
The World Health Organization (WHO) announced it will test three new drugs against COVID-19 as part of its next phase in its Solidarity trial, a global effort to test promising medicines against the virus. The agency plans to test Ipca’s malaria drug artesunate, Novartis’ chemotherapy treatment imatinib and Johnson & Johnson’s immunosuppressive infliximab, sold as Remicade.
Moderna plans to double the size of a study evaluating its vaccine in children under age 12 after the FDA asked the drugmaker to collect additional safety data, Bloomberg reports. Moderna previously expected the study to readout by the end of the year or early 2022, although interim data may come available for different age groups enrolled at different times, a spokesperson said.
Sen. Rand Paul from Kentucky disclosed that his wife bought up to $15,000 worth of stock from remdesivir maker Gilead Sciences in February of last year, 16 months behind the filing’s required deadline, the Washington Post reports. A spokesperson for the senator said the filing was delayed because it was improperly submitted, noting that Paul’s wife lost money on the investment.
The pandemic scams continue. Criminal organizations and individuals claiming to have access to vaccines have contacted officials in a number of countries trying to get them to sign phony contracts worth millions, The Wall Street Journal reports.
UPDATED: Wednesday, August 11 at 3:35 p.m.
The CDC now recommends that pregnant women, as well as those who are breastfeeding or who plan to get pregnant, get vaccinated against COVID-19. The updated guidance, which moves the agency away from its previously neutral stance, is based on growing evidence that the benefit of the shots outweigh any known risks.
Europe’s drug regulator revealed that it is investigating a possible link between mRNA vaccines and new conditions reported by a few recipients of the shots. The European Medicines Agency is trying to determine if the mRNA shots can trigger an allergic skin reaction called erythema multiforme or two kidney disorders. It has requested additional data from Pfizer, BioNTech and Moderna. Story
California will require its school teachers and staff to get vaccinated against the virus or face weekly testing, becoming the first state to impose the rule, the Washington Post reports. Gov. Gavin Newsom pointed to the quickly spreading Delta variant as a threat to the state’s efforts to reopen schools in the fall.
Researchers at UC San Diego believe Gilead Science’s remdesivir could be improved and potentially administered orally by modifying fragments of the treatment, ABC10 in San Diego reports, citing a new research paper published in the American Society for Micobiology Journals.
The Texas Department of Health plans to reopen an infusion center near Austin to administer Regeneron’s COVID-19 treatment as the state’s ICU beds begin to fill up with coronavirus patients, KXAN reports.
UPDATED: Wednesday, August 11 at 8:50 a.m.
India is in discussions with Pfizer to buy 50 million doses of its BioNTech-partnered vaccine as the country races to close supply gaps over the next few months, the Wall Street Journal reports, citing people familiar with the matter. Meanwhile, India is expecting 7 million Moderna doses from the vaccine sharing facility COVAX and is in advanced negotiations with Johnson & Johnson, the newspaper reports.
Fujifilm Diosynth isn’t to blame for Novavax’s decision to delay its FDA authorization request to the fourth quarter, the company said in a statement. Fujifilm’s defense comes after Novavax CEO Stanley Erck told Yahoo Finance that the delay was due to the U.S. government’s order for the company to work with outside firms to manufacture its doses. Fujifilm said it doesn’t perform the required analytical work needed to authorize the jab.
Planning a Hawaiian getaway? Well, you may need to adhere to new pandemic rules. Governor David Ige will re-impose some of the state’s previous restrictions, including limited indoor and outdoor social gatherings and capacity restrictions on bars, restaurants, gyms and social businesses, Reuters reports.
Southwest Airlines, American Airlines and Delta Airlines will not require their employees to get vaccinated against COVID-19, deviating from United Airlines decision to mandate the jabs for all of its workers by the end of October or face termination, CNN reports. The move from the three major airlines has drawn backlash on social media, including from former White House senior advisor Andy Slavitt, who said the companies are “not helping.”
A man who traveled to the Australian town of Byron Bay while infected with the coronavirus is being charged with breaching public health orders, the New York Times reports. The man spent over a week in the town before testing positive for the virus, averting social distancing and mask wearing measures, Mayor Michael Lyon said.
UPDATED: Tuesday, August 10 at 3:30 p.m.
Recent studies published on medRxiv, which haven’t been peer reviewed, suggest that Moderna’s vaccine may be better at tackling the Delta variant when compared with the jab from Pfizer-BioNTech, Reuters reports. One 50,000-person study from the Mayo Clinic Health System found Moderna’s jab was 76% effective against infection when the variant was spreading, down from 86% earlier in the year. Meanwhile, Pfizer’s jab fell from an effectiveness of 76% to just 42%, the research found.
Officials from the U.S. and Mexico are set to discuss a plan to reopen the shared border between the two nations, and the U.S. has already agreed to send Mexico 8.5 million additional vaccine doses, Mexican Foreign Minister Marcelo Ebrard said. The U.S. will send up to 5 million AstraZeneca jabs and 3.5 million Moderna doses, Ebrard said.
For many drugmakers, several of whom led the charge on therapeutics and vaccines taking aim at the pandemic, vaccination requirements are becoming the norm. Meanwhile, a number of biotechs have been able to forego mandates altogether because their smaller size means their workforces are already fully vaccinated. Find out how several companies are handling it. Story
Several local community leaders in Florida and Texas are preparing to defy their state governors and institute mask requirements amid the rapidly spreading Delta variant, the New York Times reports. Florida Gov. Ron DeSantis threatened to withhold salaries for local superintendents and school board members who enact the mandates in schools, despite the state’s low vaccine uptake.
UPDATED: Tuesday, August 10 at 11:00 a.m.
The National Institutes of Health (NIH) has launched a phase 2 trial studying how well a third dose of an mRNA vaccine works in kidney transplant patients who didn’t respond to two doses of the jabs from Moderna or Pfizer, according to a release. The immunosuppressive therapy that organ transplant recipients take to prevent organ rejection hinders their immune response to pathogens and the vaccines, the NIH said.
China’s latest string of pandemic restrictions amid the rapidly spreading Delta variant, first found in India, could have repercussions for the global economy, CNBC reports, citing strategist David Roche. Economists are concerned about the tough restrictions China implements to curb the virus’ spread, which could eventually hit international trade.
Moderna is working with the Canadian government to build a “state-of-the-art messenger RNA” vaccine manufacturing facility, the company said. While light on details or an official timeline, the idea is to eventually use the site to supply Canada with “direct access to rapid pandemic response capabilities," including the company’s two-dose vaccine. Story
After partnering with biomanufacturing expert Aldevron earlier this year, Ginkgo and its collaborator notched a win in the red-hot mRNA manufacturing field. Specifically, they've worked out a way to boost production yields of the vaccinia capping enzyme (VCE), which is used to make mRNA vaccines and therapeutics. While the most obvious application right now is for COVID-19 vaccines, it’s thought that there are lots of other opportunities beyond COVID, the company said. Story
Arkansas has only eight ICU beds available as the rapidly spreading Delta variant pushes hospitalizations and cases in the U.S. to a six month high, Reuters reports. Meanwhile, Texas Gov. Greg Abbott asked hospitals to postpone elective surgeries following a rapid rise in infections across states with lower vaccination rates.
UPDATED: Monday, August 9 at 3:43 p.m.
The Pentagon is set to require members of the U.S. Military to get vaccinated against COVID-19 by mid-September or once the FDA approves a vaccine, whichever comes first, the Associated Press reports, citing a memo to troops from Defense Secretary Lloyd Austin. The deadline could be pushed up if infection rates continue to climb, Austin said.
Gilead Sciences will require all U.S. employees and contractors to get vaccinated against the coronavirus by Oct. 1 “where allowed by law and where vaccine supply is readily available,” according to a press release. The drugmaker said it based its decision on the availability of effective vaccines and the rising level of infections around the globe.
Now prophesizing €15.9 billion ($18.7 billion) in COVID-19 vaccine sales in 2021, Pfizer’s German mRNA partner BioNTech will likely join the ranks of the world’s top 20 drugmakers by revenue this year. BioNTech previously said it expected to reap €12.4 billion in 2021 vaccine sales. Story
UPDATED: Monday, August 9 at 9:45 a.m.
India approved Johnson & Johnson’s single-shot vaccine a day after the drugmaker said it applied for an emergency nod. Indian biotech Biological E will supply the jab to the country, although it’s too early to tell when doses will arrive, J&J told Reuters.
White House chief medical adviser Dr. Anthony Fauci said he’s hopeful the U.S. FDA will approve a COVID-19 vaccine by the end of the month. A full approval would empower businesses and universities to mandate vaccinations among employees and students. Pfizer and Moderna have applied for a full FDA nod so far.
Novavax targeted May, then it said maybe July. Now, the company is saying it's yet again pushing back a request for emergency use authorization from the FDA for its COVID-19 vaccine. The latest delay was spurred by the U.S. government’s order for the company to work with regulators over issues regarding analytic methods before moving forward on further U.S. manufacturing. Story
Regeneron’s antibody reduces the risk of infection by 66% when delivered as an injection following an exposure to a close contact, according to a study published in the New England Journal of Medicine. The latest data follows the FDA’s decision to allow some high-risk patients to take REGEN-COV shortly after an exposure as a way to prevent severe illness.
Moderna will supply less than half of the 8.5 million doses it planned to send South Korea in August because of supply problems, Health Minister Kwon Deok-cheol said. The mRNA developer missed its late-July deliveries following issues with laboratory testing, Reuters reports.
Switzerland’s drug regulator has approved Moderna’s vaccine for adolescents aged 12 and over. Swissmedic based the decision on Moderna’s ongoing late-stage trial, which shows the vaccine is vaccine is 93% effective against symptomatic disease.
UPDATED: Friday, August 6 at 9:00 a.m.
In a trial of nearly 480,000 healthcare workers in South Africa, Johnson & Johnson's one-dose vaccine helped prevent severe disease from the Delta variant, Bloomberg reports. The trial is the first piece of large-scale evidence that shows the shot works against the variant, the news service stated. In fact, Glenda Gray, one of the leaders of the work, said the vaccine may provide better protection against Delta than the Beta variant.
Amid debate about potential booster shots, the FDA plans to lay out its plans on the issue by early September, The Wall Street Journal reports, citing people familiar with the talks. People who are immunocompromised or who received vaccines early in the United States' campaign may soon need boosters, two sources told the newspaper.
As several drugmakers vie to launch an oral COVID-19 drug, Shionogi plans to submit its candidate for patients with mild-to-moderate cases to authorities in Japan by the end of the year, The Mainichi reports. The company is also working on supplying the drug abroad, its CEO told the publication.
In partnership with Biological E, Johnson & Johnson is seeking emergency authorization for its vaccine in India, Reuters reports. So far, U.S. vaccine donations to India have been held up because the country didn't grant vaccine makers indemnity from potential side-effect related lawsuits, according to the news service.
UPDATED: Thursday, August 5 at 3:28 p.m.
Regeneron's COVID-19 antibody combo scored an FDA emergency nod after Eli Lilly's rival medicine, but sales figures for the second quarter show just how dominant Regeneron has become in recent months. Regeneron's COVID-19 combo generated $2.59 billion during the quarter compared with $149 million for Lilly's offerings. Regeneron's antibody sales grew so much in the second quarter that they eclipsed the company's entire first-quarter haul of $2.53 billion. Story
While U.S. healthcare officials haven't yet endorsed booster shots, executives with Moderna predict they'll be needed as part of the evolving pandemic response. Citing waning immunity and troublesome virus variants, Moderna expects breakthrough infections among the vaccinated in the months to come, company president and R&D chief Stephen Hoge told analysts on Thursday. Moderna expects to record about $20 billion in COVID-19 sales this year. Story
Some experts have their doubts about boosters. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, told the New York Times that the data so far don't justify boosters because vaccines are still very effective against severe disease.
As Africa battles a third wave of the pandemic, Johnson & Johnson vaccine doses are shipping out to countries around the continent, the African Union said. Officials warned that just 1.5% of Africa's population has been fully vaccinated, Reuters reports.
UPDATED: Thursday, August 5 at 9:05 a.m.
Pfizer will require employees and contractors to be vaccinated against COVID-19 or submit to weekly testing. The company said that those who have medical conditions or religious objections can seek accommodations. The news comes a day after New York City said it would require proof of vaccination at restaurants, gyms and other businesses.
Moderna’s COVID-19 vaccine retains its efficacy six months after administration of the second dose, the company said on Thursday. An efficacy rate of 93% after six months shows the durability of the vaccine which reported 94% efficacy in its original clinical trial, the company said. The result is in contrast to the staying power of the Pfizer-BioNTech vaccine. The companies reported last week that the efficacy of their shot drops 6% every two months, to approximately 84% after six months.
CVS said it has stopped providing the Johnson & Johnson COVID-19 vaccine to customers at its drugstore location. The change was implemented “several weeks ago,” according to a company spokesman. The company is still providing the J&J shot at its quick-serve clinics. CVS will continue to provide vaccines made by Moderna and Pfizer-BioNTech. The company administered 17 million shots in the second quarter.
Responding to the World Health Organization’s call for a moratorium on COVID-19 booster shots, Germany and France said they will press ahead with plans to launch their booster programs in September. Both countries plan to offer boosters to the elderly and those most at risk. The WHO’s call is an effort to get vaccines to the many poor, supply-strapped countries of the world.
As part of a plan to lift travel restrictions that prevent foreign visitors from entering the United States, the country may soon require them to be fully vaccinated against COVID-19. According to Reuters, the Biden administration is working on a plan that would re-open travel, boosting commerce and tourism, while still ensuring safety.
Florida Gov. Ron DeSantis has defied President Joe Biden, saying he would block any federal COVID-19 restrictions that would hurt business or infringe on the rights of citizens in the state. Florida has more than 11,000 hospitalized with the disease, prompting a Biden threat to mandate restrictions.
UPDATED: Wednesday, August 4 at 4:05 p.m.
In an effort to boost COVID-19 vaccine supplies to poorer countries, the World Health Organization has called for a moratorium on booster shots through at least September. The call comes as countries such as Russia, Germany and Israel make plans to provide booster shots while many other countries have a dearth of supplies.
Researchers in India have found that a century-old tuberculosis vaccine may have the ability to combat the coronavirus. The Bacillus Calmette-Guerin vaccine can reduce inflammation in elderly people, scientists reported in a study published in Science Advances. Uncontrolled inflammation is a key factor in severe COVID-19. Story
China, once an example of how to contain the coronavirus and quickly reopen, is now dealing with its own Delta variant concerns as the strain has appeared in 15 of the country’s 31 provinces. Only 438 cases have been reported but the wide geographic dispersal has alarmed health officials and put the country’s handling of the virus under scrutiny as some have wondered if the country let its guard down too early.
A solvent leak from a hosepipe at a plant in Germany producing COVID-19 vaccines for BioNTech has landed four in the hospital. The incident happened at a Rentchler factory in Laupheim but did not interrupt production. Last week an incident at a chemical plant in Leverkusen, Germany, killed two and injured dozens.
The FDA has sped up its timeline for full approval of the Pfizer-BioNTech COVID-19 vaccine, establishing an unofficial deadline of Labor Day, said The New York Times. The urgency comes in response to the Delta variant sweeping across the United States. Polls show that 3 in 10 unvaccinated people say they would consider receiving a shot if the vaccine was fully endorsed. Such a move also would give businesses and other entities the legal muscle to mandate vaccinations. Story
A handshake deal made in December by Novavax to supply COVID-19 vaccines to Europe has finally been formalized. The company will provide Europe with up to 200 million doses of its yet-to-be approved protein-based vaccine. The deal was put on hold by the company as it worked through production problems. It helps Europe diversify its vaccine stock after the bloc announced that it would not renew contracts with adenovirus vaccines produced by AstraZeneca and Johnson & Johnson. Story
UPDATED: Wednesday, August 4 at 9:05 a.m.
People living in San Francisco who have received Johnson & Johnson's one-dose vaccine will be eligible for a "supplemental" dose of an mRNA vaccine from Pfizer or Moderna. People who've spoken with their doctors and wish to receive another vaccine will be eligible, SFGate reports.
Officials in New York City aren't following that same path just yet. New York City health commissioner Dave Chokshi said that while the approach is under review, the city doesn't yet recommend supplemental doses, Staten Island Live reports.
Recognizing that some people who haven't gotten COVID-19 vaccines are waiting for a full approval, the FDA plans to quickly move on Pfizer's application, The New York Times reports. The agency hopes to approve the shot by the beginning of September.
When monoclonal antibodies first hit the scene, experts voiced concerns that not enough people were taking advantage of the treatments that can prevent severe cases of COVID-19. That's not the case anymore, at least in Mississippi. Two hospitals there are at their capacity to deliver Regeneron's treatment, WLOX reports.
NRx Pharmaceuticals, which has won a FDA fast track designation for Zyesami in acute lung injury or acute respiratory distress syndrome from COVID-19, partnered with MannKind to work on a dry powder formulation of the med. Release
UPDATED: Tuesday, August 3 at 3:10 p.m.
The U.S. has donated over 110 million doses of coronavirus vaccines to more than 60 countries, totaling more in donated shots than all other countries combined, the White House said. The Biden administration said that this doesn’t include the half a billion Pfizer-BioNTech doses it purchased for low-income countries, which will begin shipping out at the end of this month.
Alnylam Pharmaceuticals and Vir Biotechnology are ditching their COVID-19 antiviral as the Delta variant picks up steam throughout the world. The move was characterized as a "portfolio prioritization" and revealed as part of the company's second-quarter financial results. Alnylam claimed the availability of "highly effective vaccines and alternative treatment options" was the reason behind the axing. Story
The U.S. Department of Justice and the Securities and Exchange Commission has subpoenaed CytoDyn and its executives for documents related to its public statements about leronlimab, under development to treat patients with severe COVID-19. CytoDyn faced a rare public rebuke from the FDA in May, which accused the company of cherry-picking data from its phase 3 trial to claim the drug was effective in some populations. CytoDyn said it’s “cooperating fully” with the investigations. Story
New York is the first city in the U.S. to mandate vaccines for people entering an array of indoor businesses, such as restaurants and gyms, amid the rapid rise of the Delta variant. The policy, which starts Sept. 13, will require customers to have at least one dose.
UPDATED: Tuesday, August 3 at 9:20 a.m.
Plummeting sales of COVID-19 antibodies because of decreased demand and the FDA’s pause in late June have kept Eli Lilly from meeting revenue expectations in the second quarter. After generating revenue of $810 million in the first quarter, Lilly’s antibodies generated just $149 million in sales in the second quarter. The FDA sidelined the treatment after studies showed it was ineffective against certain COVID-19 variants. Story
A phase 3 study of Lilly and Incyte’s baricitinib showed that those who received the drug plus standard of care were 46% less likely to die by day 28 than those who were on placebo and standard of care. The study included 101 patients on mechanical ventilation or extracorporeal membrane oxygen.
Four additional pharma companies in India will begin COVID-19 vaccine production by November, the country's health minister said. The firms will join Bharat Biotech and the Serum Institute of India, which have been supplying shots. The country of 1.366 billion has administered 470 million vaccine doses. Additionally, India’s production of Gilead’s COVID-19 treatment remdesivir is ramping up.
UPDATED: Monday, August 2 at 4:00 p.m.
Germany will offer vaccine boosters to older people and people with underlying health conditions amid growing concern over the rapidly spreading Delta variant, the New York Times reports, citing a draft plan. The move comes amid criticism that wealthier nations are handing out boosters at a time when some countries don’t have adequate access to any doses.
Johnson & Johnson said it's still working with Indian authorities over its single-shot vaccine after the company reportedly pulled its application for an accelerated approval. Earlier this year, J&J sought to conduct a bridging trial, which would test its jab in India before scoring a regulatory nod. However, India has since scrapped local trials for "well-established" vaccines. A J&J spokesperson told Reuters that the company is still in "ongoing discussions" with the government.
Roughly 70% of U.S. adults over the age of 18 have now received at least one dose, nearly a month after President Joe Biden’s July 4 goal, according to CDC data. About half of the U.S. population who are vaccine eligible are now fully inoculated.
UPDATED: Monday, August 2 at 9:55 a.m.
The FDA plans to push back some of its responsibilities, such as plant inspections and drug sponsor meetings, to prioritize Pfizer’s application for a full approval of its BioNTech-partnered vaccine, Stat News reports, citing sources familiar with the matter. It’s thought that a full approval for Pfizer’s jab could convince more people to get inoculated and give vaccine requirements stronger legal backing.
Pfizer and Moderna raised the prices of their mRNA jabs in their latest supply deals with the European Union, The Financial Times reports. Pfizer’s price tag came in at €19.50 ($23.15) compared with €15.50 previously. Meanwhile, Moderna’s shot came in at $25.50, slightly over the €19 ($22.57) in its earlier deal. However, that’s lower than a previously agreed $28.50 because the EU expanded its order, according to a source.
It’s likely the U.S. won’t have to resort to lockdowns to thwart the recent spread of COVID-19, White House chief medical officer Dr. Anthony Fauci told ABC’s “This Week." However, Fauci warned that “things are going to get worse” because of the Delta variant. While enough of the population has been vaccinated to avoid lockdowns, it's not enough to “crush the outbreak," he said.
The United Arab Emirates (UAE) will offer China’s Sinopharm vaccine to children aged 3 to 17, becoming one of the few nations to offer jabs to a wide swath of children. The UAE’s health ministry said the decision was based on clinical trials and local evaluations. The country joins China in offering Sinopharm’s vaccine to children, Bloomberg reports.
Britain is set to offer booster shots to 32 million people beginning this fall, enlisting up to 2,000 local pharmacies to administer the jabs, the Telegraph reports. The goal will be to begin extra vaccinations in early September and complete the rollout by December.
UPDATED: Friday, July 30 at 8:50 a.m.
An internal CDC presentation said the Delta variant, first found in India, appears to cause more severe illness and can spread as easily as chickenpox, the Washington Post reports. The presentation revealed that the agency is urgently working to bolster its public messaging around vaccinations, acknowledging “the war has changed.”
Japan has extended its state of emergency at its capital at Tokyo amid the Olympic Games. Tokyo in recent days has set fresh records when it comes to new infections, reporting over 3,000 cases daily. Meanwhile, Japan will resume using AstraZeneca’s jab after it held back the jab over blood clot concerns, local media report. AZ’s shot will likely be reserved for those aged 40 and older.
Mixing Russia’s Sputnik V jab with AstraZeneca’s shot didn’t produce any safety risks or any coronavirus cases, according to the Russian Direct Investment Fund (RDIF), which is charged with selling Sputnik V. The RDIF said it will present more detailed results from a 50-person trial next month. Meanwhile, China’s CanSinoBIO may kick off its own trial as early as next month that would pair its jab with Sputnik V, an executive said.
The Serum Institute of India (SII) will partner with the Confederation of Indian Industry (CII) to expand inoculations in India’s rural countryside, where a majority of the country’s population reside, Reuters reports. SII, which has boosted its production of AstraZeneca’s jab in recent months, will usher its supply of doses to vaccination camps CII has arranged in small towns.
UPDATED: Thursday, July 29 at 4:00 p.m.
The FDA expanded its emergency use nod for Eli Lilly’s baricitinib for hospitalized COVID-19 patients, allowing the treatment to be administered on its own. The drug was previously administered alongside Gilead Science’s remdesivir in patients requiring supplemental oxygen. The agency said the revision was supported by data that found baricitinib, also known as Olumiant, reduced the amount of patients who died after four weeks versus standard of care.
President Joe Biden is pushing state and local governments to hand out $100 to those who get vaccinated against COVID-19, according to the Treasury Department. The funding to pay for the cash incentives could come from the $350 billion in relief aid granted to states, cities and territories as part of the American Rescue Plan Act.
UPDATED: Thursday, July 29 at 8:19 a.m.
AstraZeneca is “exploring different options” for its COVID-19 vaccine unit as top executives discuss whether the business is sustainable, Reuters reports, citing Executive Vice President and President of the BioPharmaceuticals Business Unit Ruud Dobber. AZ will have “more clarity” before the end of the year, Dobber said.
Emergent BioSolutions will resume production of Johnson & Johnson’s vaccine, executives said, months after operations were halted due to contamination concerns. The drugmakers have been working with the FDA to clear Emergent’s Baltimore plant since halting production in April. Regulators have since approved five batches of J&J doses made at the plant.
Meanwhile, Canada and Mexico imported millions of AstraZeneca doses and offered them to the public before properly inspecting Emergent’s Baltimore facility, Reuters reports, citing interviews with regulators and inspection records. Those countries imported the doses based on a facility review from European regulators, which ended up being inadequate. Production at the site was halted a few weeks later.
Johnson & Johnson’s jab was awarded another shelf life extension from the FDA. The shot can now be held for up to 6 months, up from a previously authorized 4.5 months, according to a letter from the agency. The move comes amid concerns from state health officials that the shots would expire soon.
The CDC said nearly 67% of U.S. counties have virus transmission rates high enough to call for indoor mask wearing, even for those who are vaccinated. About half of counties have spread that the agency would consider “substantial,” meaning at least 50 new cases per 100,000 people over the last week.
UPDATED: Wednesday, July 27 at 3:25 p.m.
Pfizer maintained that a third booster shot of its mRNA vaccine could “strongly” boost protection against the troublesome Delta variant, first found in India, according to slides from its earnings presentation. In a new study, which hasn’t been peer reviewed, the company and German partner BioNTech found the shot's efficacy against symptomatic infection wanes after four to six months, but that it’s still highly protective against severe disease. Pfizer said it plans to file its booster for an emergency FDA nod as early as August.
Meanwhile, Pfizer also plans to move its intravenous COVID protease inhibitor, PF-07304814, into a phase 2/3 clinical trial in hospitalized patients in the third quarter. The drugmaker also expects to have phase 2/3 data on its oral drug, PF-07321332, in the fourth quarter. Story
President Joe Biden is set to announce on Thursday that all federal employees will have to be vaccinated against COVID-19 or face strict testing rules, NBC News reports. The final details of the proposal haven’t been finalized and are subject to a review, according to sources. The president also plans to outline new measures the administration will take to boost vaccination rates.
England will allow travelers from the U.S. and European Union countries to arrive in the country without needing to quarantine beginning next week, Reuters reports. However, visitors will be subject to testing before they depart and upon arrival.
UPDATED: Wednesday, July 27 at 9:45 a.m.
GlaxoSmithKline and Vir Biotechnology have inked a supply deal with the European Union for up to 220,000 doses of their monoclonal antibody, sotrovimab. The treatment is used in adults and adolescents aged 12 and older who aren’t on oxygen but could develop severe disease. Doses will be available to member states once they issue their own authorizations, GSK said.
Pfizer is upping its full-year vaccine sales expectations once again. Three months after estimating 2021 revenues for its COVID-19 vaccine Comirnaty would reach a whopping $26 billion, Pfizer has jacked up its estimate by an additional $7.5 billion. The company now predicts 2021 sales of $33.5 billion for its BioNTech-partnered mRNA shot as it enters another stratosphere among the most lucrative drug products in history. Story
CanSinoBio’s two-dose inhaled COVID-19 vaccine triggered immune responses among a small group of adults without any serious safety risks. The neutralizing antibodies produced following the inhaled version were similar to those seen after a single jab with the company’s injectable vaccine, according to results published in the medical journal the Lancet Infectious Disease.
AstraZeneca’s vaccine, known as Vaxzevria, was found to have a similar safety profile when compared to the mRNA jab from Pfizer and BioNTech, according to a new pre-print study. Researchers studied rates of blood clotting disorders, including venous thromboembolism (VTE), arterial thromboembolism (ATE), thrombocytopenia and the very rare thromboembolism with thrombocytopenia (TTS) among more than 1.3 million people vaccinated with the two jabs.
UPDATED: Tuesday, July 27 at 3:42 p.m.
The CDC reversed its masking guidance and now suggests that even fully vaccinated people wear a face covering inside in parts of the country where the virus is spreading widely. While the risk of severe illness for vaccinated people is still low, new evidence suggests the highly infectious Delta variant can cause breakthrough infections, and vaccinated people may spread it to others.
Canadian Prime Minister Justin Trudeau said the nation now has enough vaccines on hand for all residents who are eligible, two months ahead of schedule. As of mid-July, just over 57% of adult Canadians had been fully vaccinated, roughly in line with the U.S., Reuters reports.
Lawmakers are questioning the FDA over how it can ensure the safety and quality of drugs that arrive from outside the country. The agency halted most inspections during the pandemic—domestic and abroad—to focus on those that were deemed critical. But now that it’s restarted most U.S. inspections, lawmakers are concerned that the “strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” according to a letter sent to acting FDA Secretary Janet Woodcock. Story
UPDATED: Tuesday, July 27 at 9:25 a.m.
Brazilian regulators have scrapped the emergency use authorization request from Bharat Biotech for its vaccine, just days after the country terminated the company's proposed clinical trials. Brazil’s decision to cancel the clinical trials and Bharat’s application come after the Indian drugmaker severed ties with a local partner.
South Korea said end-of-July shipments of Moderna’s vaccine will now be pushed to August as the mRNA developer faces supply issues at European manufacturing sites that will likely impact other countries, Reuters reports. The issues stem from Swiss CDMO Lonza and another Moderna partner in Spain, officials said.
Daewoong Pharmaceutical’s oral COVID-19 pill, known as Coviblock, failed to reach its primary endpoint in a phase 2 trial when compared with placebo, Korea Biomedical Review reports. The company was studying whether the pill could reduce the time for symptoms to improve. While Daewoong’s pill was considered safe, there was no statistical difference in improved patient symptoms.
India’s health ministry said it will meet its target of supplying more than 500 million doses to its citizens by July’s end, although not all doses may be administered yet. So far, 457 million jabs have been delivered, leaving 60.3 million expected to ship out by the month’s end, Reuters reports. Just 10% of the nation’s adult population is fully vaccinated, according to the ministry’s website.
UPDATED: Monday, July 27 at 3:38 p.m.
The call for mandatory vaccinations is growing louder. In one joint statement, 56 health care associations called upon their members, including long-term care facilities, to require vaccinations among their staff. The U.S. Department of Veterans Affairs became the first federal agency to say it will require inoculations among 115,000 of its frontline health care workers. Meanwhile, New York City Mayor Bill de Blasio ordered mandatory weekly testing for all unvaccinated municipal employees in an effort to drive up vaccination rates. Then, California Gov. Gavin Newsom followed suit in a similar order.
AstraZeneca, frequently criticized over its delivery delays to the European Union, was able to ship the entirety of its court-ordered doses ahead of schedule, a European Commission spokesperson told CGTN. The company has so far delivered nearly 100 million doses to the bloc, including 50 million that were required by a Belgian court by the end of September.
South Korea said mRNA developer Moderna has reported a production problem with its vaccine, although details over the delay weren’t immediately available, Reuters reports. The reported issues come just as the country tries to widen vaccine eligibility to more adults.
UPDATED: Monday, July 26 at 9:30 a.m.
Japanese drugmaker Shionogi has started testing a once-a-day COVID-19 pill that's designed to thwart the virus before it progresses, the Wall Street Journal reports. Shionogi’s drug joins the race for an oral treatment against the virus, joining similar pills from Pfizer and Merck.
U.S. health officials are warming up to the idea that Americans with vulnerable immune systems may need a booster vaccine. Further, White House chief medical advisor Dr. Anthony Fauci told CNN that the CDC is considering revising its masking guidance for vaccinated Americans.
U.S. COVID-19 infections are “spiraling out of control” as the Delta variant sweeps across the country, placing unvaccinated Americans at risk, former Trump administration surgeon general Jerome Adams told CNN. Adams warned that “more mitigation is coming,” whether that’s masking, virtual learning or business closures. Nearly half of Americans eligible for a vaccine have been fully vaccinated so far, CDC data show.
A combination of vaccine doses from AstraZeneca and then Pfizer induced an antibody response that was six times higher compared with two doses of AZ’s jab, Reuters reports, citing a study from South Korea. The latest study, which included nearly 500 medical workers, adds to the growing evidence that mixed dosing regimens may induce greater protection.
South Africa’s Aspen Pharmacare is set to begin supplying the country with Johnson & Johnson vaccines it manufactured with active pharmaceutical ingredients sourced from Europe. This marks the first time shots will be produced on the African continent by an African company for South African and African recipients, Aspen said.
UPDATED: Friday, July 23 at 9:40 a.m.
Pfizer and vaccine partner BioNTech have inked another U.S. supply deal worth 200 million doses, bringing the country’s total to 500 million. That’s separate from another 500 million doses the pair said they’d provide the U.S. government to donate to other countries. The latest doses will be delivered between October of this year through April 2022, according to a statement.
Johnson & Johnson’s single-shot vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel decided following reports of a rare nerve disorder following the jab. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA. Story
A key safety group for the European Medicines Agency (EMA) signed off on Moderna’s vaccine, dubbed Spikevax, for adolescents as young as 12, the company said. Moderna has previously said it’s seeking an emergency nod in the U.S. for the age group as well. The EMA’s recommendation will now go to the European Commission for its approval.
As the Olympics commence, host nation Japan is pushing Pfizer to speed up its promised vaccine deliveries, financial newspaper The Nikkei reported following a meeting between Japanese Prime Minister Yoshihide Suga and Pfizer chief Albert Bourla.
Bharat Biotech said it would supply India’s vaccination program with more than 500 million doses of its vaccine, Covaxin. Speaking at a conference, Bharat’s Suchitra Ella said the company has facilities in four cities across India currently producing the doses.
UPDATED: Thursday, July 22 at 4:10 p.m.
The European Medicines Agency has warned of a possible “causal relationship” between the Johnson & Johnson COVID-19 vaccine and Guillain-Barre syndrome, a rare nerve-degenerating disease. The disorder has been reported by 8.1 per 1 million recipients of the J&J shot as opposed to 1.1 per million recipients of mRNA vaccines produced by Moderna and Pfizer-BioNTech. On Thursday, the CDC weighed in as well, saying the benefits of the J&J shot far outweigh the risks.
The European Union has donated only 3% of the 160 million COVID-19 vaccine doses it has pledged to deliver to poor countries, according to an internal bloc document. EU nations, with an adult population of roughly 365 million, have received roughly 500 million doses so far and expect to have possession of nearly 1 billion doses by the end of September, but as of July 13 it had donated less than 4 million shots.
Data research hubs BREATHE and IQVIA have teamed up to accelerate early diagnosis and treatment of respiratory conditions in the UK, including long COVID. The goal is to improve the accuracy of diagnoses, increase the availability of personalized treatments and ramp up quicker referrals to specialist care. Additionally, through the use of non-identified health data, the organizations hope to spur research and innovation. Story
Boosted by a $200 million investment by the United States, Aspen Pharmacare of South Africa will be able to increase its capacity to produce the Johnson & Johnson COVID-19 vaccine and potentially to help alleviate the continent’s shortfall. Only 1.5% of Africa’s 1.3 billion people have been fully vaccinated. Aspen and J&J revealed their vaccine partnership in November. J&J has pledged to deliver 220 million doses of its single-shot vaccine to South Africa. Story
Even without including COVID-related earnings, Abbott saw double-digit sales growth across its business in the second quarter of 2021, another indication that business is returning to normal after a tumultuous year turned upside down by the coronavirus pandemic. Fueled by sales increases of 57% in diagnostics and 45% in medical devices over the same period a year ago, Abbott rang up global sales of $10.2 billion during the quarter, up 35% from 2020. Story
UPDATED: Thursday, July 22 at 11:30 a.m.
Japan is the first country to grant full approval to Roche's antibody combo of casirivimab and imdevimab for COVID-19. The country's Ministry of Health, Labour and Welfare cleared the drug, which also goes by the name Ronapreve, to treat patients with mild-to-moderate disease. In the phase 3 REGN-COV 2067 study, Ronapreve slashed hospitalizations or deaths by 70% and cut symptom duration by four days, Roche said in a release. The antibody combo boasts emergency nods in places like the U.S., the E.U., India, Canada and Switzerland, Roche said.
A double dose of Pfizer's or AstraZeneca's vaccines works about as well against the Delta variant as they do against Alpha, Reuters reports, citing a study published Wednesday in The New England Journal of Medicine. Two shots of Pfizer's BioNTech-partnered mRNA vaccine showed 88% efficacy against symptomatic disease caused by Delta, versus 93.7% against Alpha. AstraZeneca's two-dose regimen proved 67% effective against Delta, up from a previously reported 60%, while the shots were 74.5% effective against Alpha.
The CDC's Advisory Committee on Immunization Practices (ACIP) will meet Thursday to talk about the potential need for COVID-19 booster shots and to address fresh safety concerns about Johnson & Johnson's single-dose vaccine, ABC Action News reports. Last week, the regulator updated the shot's label to include the rare risk of Guillain-Barré syndrome (GBS) after vaccination. Health officials say there have been about 100 preliminary reports of GBS out of some 13 million people vaccinated with J&J's shot, ABC said.
A COVID-19 vaccine could snag full FDA approval sometime between late August and October, President Joe Biden told a town hall audience in Ohio, as quoted by The New York Times. "Soon, I believe," children younger than 12 will be able to get the vaccine on an emergency basis, he added. Health experts have been calling for a full approval of shots currently authorized for emergency use as a means to increase vaccination rates.
Taiwan bought another 36 million doses of Moderna's mRNA vaccine, Reuters reports. The country has received some 9 million Moderna doses so far, about 6 million of which came through donations from the U.S. and Japan. The country's health minister said 1 million of those doses are expected by the end of this year, followed by 20 million next year and 15 million in 2023.
UPDATED: Wednesday, July 21 at 2:50 p.m.
Johnson & Johnson’s second-quarter results show that its medtech business has rebounded significantly from coronavirus lockdowns, even outpacing pre-pandemic levels in some treatment areas. Device revenues were not only up 57.2% over the same period in 2020, but adjusted sales were also up 7% over 2019 revenues. Story
Amid a surge of medical misinformation, including on the subject of COVID-19 vaccines, YouTube is partnering with Mass General to promote credible content. Story
Johnson & Johnson expects to generate $2.5 billion this year from its single-shot COVID-19 vaccine. In its second-quarter report, J&J recorded revenue of $164 million for the program. Despite concerns about the shot’s safety and its effectiveness against the Delta variant, J&J sees the shot gaining steam later this year. Story
After Australia's government asked the life sciences industry for proposals to help in the local immunization push, 12 companies responded with pitches, the Sydney Morning Herald reports. Details are still sparse as the companies wait for the government to review pitches.
UPDATED: Wednesday, July 21 at 9:20 a.m.
Despite CureVac’s disappointing late-stage vaccine readout last month, Novartis said it’s still helping the German mRNA maker produce 50 million doses by the end of 2021. Novartis’ finance chief, Harry Kirsch, said the company could expand its capacity to assist other vaccine developers as well.
Pfizer and BioNTech inked an agreement with South Africa’s Biovac Institute to produce more than 100 million doses of the pair’s shot per year for the African Union, according to a statement. Biovac will obtain vaccine substance from European facilities and manufacture finished doses starting in 2022. Story
Authorities in Mexico said they’ve found fake doses of Gilead’s remdesivir at a private hospital near the U.S. border city of Tampico and for sale online, the Associated Press reports. Officials did not say whether the doses had been used but classified it as a “health risk.”
The vaccine from China’s Sinopharm showed a 1.38-fold reduction in antibody response against the troublesome delta variant, first found in India, and a 10-fold reduction against the beta variant when compared to older strains of the virus in a new study.
People who’ve received a single shot of Johnson & Johnson’s vaccine should consider getting a booster with Moderna or Pfizer’s jab, Vin Gupta, M.D., a professor at the University of Washington’s Institute for Health Metrics and Evaluation, told CNBC. Gupta’s comments come after a new, non-peer-reviewed study from New York University raised concerns about the effectiveness of J&J’s shot against the delta variant.
Life expectancy in the U.S. dipped by a year and a half in 2021 amid the pandemic to 77.3 years, the CDC reported. That’s the lowest level since 2003 and the biggest decline since World War Two, when life expectancy fell 2.9 years between 1942 and 1943.
UPDATED: Tuesday, July 20 at 3:00 p.m.
European drug regulator has started a rolling review of Sanofi and GlaxoSmithKline's protein-based vaccine, dubbed Vidprevtyn. The European Medicines Agency (EMA) said its review will be based on preliminary results from laboratory studies as well as early adult clinical studies that showed Vidprevtyn triggers antibodies against the virus. Story
The troublesome Delta variant, first found in India, now accounts for 83% of new U.S. cases, CDC Director Rochelle Walensky told lawmakers. That marks a “dramatic increase” from July 3, when that figure was just 50%. The level of Delta variant cases is even higher in some communities with low vaccination rates, Walensky said.
Millions of doses are set to expire this fall as states face dwindling demand, and the Biden administration has denied requests to send the shots abroad, Stat News reports. CDC data shows that there are roughly 52 million doses that have been sent to states that are still unused, but U.S. officials say logistic and legal hurdles are preventing those shots from going to countries in need.
UPDATED: Tuesday, July 20 at 8:45 a.m.
AstraZeneca told Thailand that it could supply about 6 million doses per month, short of the 10 million shots the nation claimed the drugmaker owes, Reuters reports, citing internal discussions. The news comes as Thailand considers imposing a limit on vaccine exports to neighboring countries in a push to increase inoculations among its own residents.
Regeneron has scored its first full approval for its COVID-19 antibody cocktail, a blend of casirivimab and imdevimab, in Japan. The company’s cocktail, known as REGEN-COV in the U.S. and Ronapreve in other countries, currently has temporary or emergency nods in more than 20 countries.
Moderna and Japanese pharma Takeda have struck a supply deal worth 50 million doses for Japan in 2022, including the option for booster shots, if approved. Takeda, along with Japan’s health ministry, is charged with importing, regulatory and distribution efforts. This brings Japan’s total secured supply of Moderna doses to 100 million.
India’s true pandemic death toll is likely more than 3 million, far higher than the more than 400,000 fatalities it’s reported so far, a new study from the Center for Global Development shows. Researchers studied death records, household surveys and India’s seroprevalence compared to age-specific mortality rates to reach the conclusion.
UPDATED: Monday, July 19 at 3:40 p.m.
Canada will ease border restrictions with the U.S. starting Aug. 9, a highly-anticipated decision that will allow fully vaccinated Americans into Canada for nonessential travel. To enter Canada, U.S. residents will have to present a negative test taken within 72 hours of arrival, as well as proof that they’ve been fully inoculated with a shot already approved in Canada. The U.S. has not determined, however, if it will welcome Canadian travelers, the Washington Post reports.
A federal judge upheld Indiana University’s decision to require vaccinations among its students, writing that “the balance of harms and the public interest” favor the university’s decision for the fall semester. Eight students sued the university over its mandate last month, claiming the measure violated the 14th Amendment.
Adagio Therapeutics has filed an initial public offering to raise money to bring its antibody to market. The IPO will support phase 2/3 clinical trials that the company is running to position ADG20 for the treatment and prevention of COVID-19. Story
The U.S. CDC raised its warning level for Americans traveling to the U.K. to its highest and most severe level, just after the U.K. largely dropped its pandemic restrictions.
UPDATED: Monday, July 19 at 9:15 a.m.
The European Union’s drug regulator is reviewing the arthritis drug Kineret, also known as anakinra, to treat COVID-19 patients with pneumonia who are at risk of severe respiratory failure. The European Medicines Agency (EMA) said it would review data from two ongoing clinical trials of the IL-1 targeting drug, made by rare disease specialist Sobi.
England has shed nearly all of its remaining pandemic restrictions, despite a recent spike in infections driven in part by the troublesome delta variant, first found in India. Prime Minister Boris Johnson urged residents to tread cautiously as the nation moves to lift rules on mask-wearing, social distancing and indoor gatherings.
Taiwan approved the vaccine from Medigen Vaccines Biologics Corp., although the shot hasn’t completed late-stage testing yet. Officials said the Taiwan-based drugmaker’s jab produced an antibody response “no worse” than AstraZeneca’s vaccine currently deployed in the region. Medigen began phase 2 testing in January.
Facebook defended itself from President Joe Biden’s claim that social media giants were “killing people” by allowing vaccine misinformation to proliferate online. A company executive claimed that a majority of U.S. users have been or want to be vaccinated and that the Biden administration shouldn’t use Facebook as a scapegoat for missing its goal of administering a dose to 70% of adult Americans by July 4.
Mexico is set to authorize Moderna’s vaccine “very soon,” Reuters reports, citing Foreign Minister Marcelo Ebrard. The shot would join a handful of others deployed in the country, including the mRNA rival from Pfizer-BioNTech and Johnson & Johnson’s single-shot jab.
UPDATED: Friday, July 16 at 9:00 a.m.
Pfizer’s BioNTech-partnered vaccine spurred an antibody response that was nearly 10 times greater than the jab from China’s Sinovac, according to a new Hong Kong study. The study, which enrolled more than 1,400 healthcare workers, said the elevated antibody levels could “translate into substantial differences in vaccine effectiveness.” Researchers didn't test other sources of protection, such as T cells.
African countries will receive their first shipments of 25 million donated U.S. vaccine doses in the coming days, Gavi, the vaccine alliance, said in a statement. The Johnson & Johnson jabs will be initially sent to Burkina Faso, Djibouti and Ethiopia, but eventually the donated doses will spread out across 49 countries.
Canada is preparing to reopen its border to vaccinated travelers from all countries in early September if infections continue to decline, Prime Minister Justin Trudeau said in a statement. Immunized U.S. travelers and permanent residents could be allowed in for nonessential reasons by mid-August.
A week before the Tokyo Olympics are scheduled to commence, organizers are already facing a rising number of infections among incoming travelers, including one Nigerian official who was hospitalized upon arrival, The New York Times reports. So far, there have been 30 reported cases among Olympic-related workers this month.
UPDATED: Thursday, July 15 at 3:45 p.m.
The chief of the World Health Organization (WHO) said the global health organization will outline the next study into the origins of the coronavirus on Friday. WHO director-general Tedros Adhanom Ghebreysus said the investigation has been hindered because of the lack of data on the initial days of its spread in the country, Reuters reports.
Meanwhile, a key WHO expert panel maintained that people shouldn’t be required to provide vaccination status in order to travel. The independent group argued that the vaccination rollout has been inequitable so far.
The U.S. surgeon general chastised social media companies for not doing enough to prevent vaccine misinformation from disseminating online. Dr. Vivek Murthy wrote that the misinformation is a “serious threat to public health.”
UPDATED: Thursday, July 15 at 9:15 a.m.
The mRNA vaccine from BioNTech and Fosun Pharma has completed an expert regulatory review phase in China and is now in the administration review phase, Chinese media group Caixin reported, citing Fosun. The shot is scheduled to start a trial production run in the country by the end of August. The pair plan to offer the jab as a booster to inactivated vaccines.
Ocugen has kicked off a rolling submission for its Bharat Biotech-partnered vaccine, known as Covaxin, in Canada, the Pennsylvania-based drugmaker said. The shot is currently used in just a handful of countries, such as India, Mexico and Brazil. The submission follows the pair’s recent encouraging phase 3 readout.
AstraZeneca has asked Thailand to delay its timeline for 61 million shots by five months, Reuters reports, citing a deputy minister. The delay stems from a slow manufacturing start for a local partner. The news comes just a day after the news agency reported that Thailand was considering curbing vaccine exports to handle its own needs.
Moderna’s market cap reached $100 billion and briefly matched that of pharma heavyweight GlaxoSmithKline, an achievement that shows how the pandemic has cemented the once controversial biotech into a major behemoth. Story
Haiti has received 500,000 donated Moderna doses from the U.S. through the global vaccine sharing program COVAX, according to Pan American Health Organization (PAHO), although the country has yet to start any inoculations. The doses were part of the Biden administration’s 12 million doses earmarked for nations in Latin America and the Caribbean.
UPDATED: Wednesday, July 14 at 4:00 p.m.
The European Union’s drug regulator is reviewing a small number of cases of an auto-immune disorder following shots of Moderna’s mRNA vaccine, according to a safety document. The condition, known as immune thrombocytopenia, is marked by low platelet levels that can lead to bruising and bleeding, the European Medicines Agency (EMA) said. A link between Moderna’s shot and the cases has not yet been established.
Meanwhile, the EMA refrained from making a recommendation over whether countries should mix and match vaccine doses from different manufacturers, Reuters reports. The EU’s drug regulator also said it was too early to determine the need for a booster.
Brii Biosciences said its monoclonal antibody combination therapy “remains active against most of the major variants" of the coronavirus. The company expects a phase 3 readout in the fourth quarter this year. Story
Thailand is considering limiting its exports of AstraZeneca’s vaccine to help battle its own crisis, a move that would mirror India’s decision earlier this year and could hamper neighboring countries.
UPDATED: Wednesday, July 14 at 9:00 a.m.
The head of the World Trade Organization (WTO), director-general Ngozi Okonjo-Iweala, said the global vaccine sharing program COVAX is struggling because some countries are able to out-bid it for a smaller amount of supplies, Reuters reports.
GlaxoSmithKline and Vir Biotechnology scored a temporary approval in Italy for their antibody treatment sotrovimab. The European Union backed the drug in May, but individual member states can decide whether to use the drug or not. Italy’s approval is good through February 2022.
Tennessee’s former top vaccination official blasted state leaders after she was fired from her job last week. Dr. Michelle Fiscus said she was a scapegoat for Republican state leaders angered by the health department’s efforts to vaccinate more teens.
Australia-based Ena Respiratory has begun a phase 1 clinical trial of its nasal spray for the prevention of COVID-19 and other respiratory viral infections. The study is expected to wrap up in the third quarter. Story
New infections in the U.S. are on the rise once again after weeks of steep declines, a worrisome sign as the fast-spreading delta variant takes hold, the Associated Press reports. Daily new cases grew to an average of roughly 23,600 as of Monday, up from a previous 11,300 on June 23, according to Johns Hopkins University data.
UPDATED: Tuesday, July 13 at 2:55 p.m.
After links to rare but serious blood clots hurt perceptions of their COVID-19 vaccines, Johnson & Johnson and AstraZeneca are considering tweaking the shots to potentially cut down on safety risks, The Wall Street Journal reports. A J&J spokesman told the newspaper the company supports "continued research and analysis" on the subject, while AZ has said it's "actively working" with experts to better understand the "extremely rare blood-clotting events."
With the COVID-19 vaccine campaign in the U.S. well underway, demand for testing has declined sharply. That's affecting financials for diagnostics makers who are having to rewrite financial predictions halfway through the year. One of them, Qiagen, just slashed its 2021 expectations. Story
More than 1 million French citizens made vaccine appointments one day after president Emmanuel Macron instituted tougher vaccine requirements in the country, The Associated Press reports. The figure was far and away a daily record.
Morning update on Macron demolishing French anti-vax feeling (or at least vax-hesitant): nearly 1m vaccination appointments made yesterday, an absolute daily record, via @nicolasberrod pic.twitter.com/V66dEv32VN— Sophie Pedder (@PedderSophie) July 13, 2021
As the U.S. continues its vaccine push, the White House has teamed up with music star Olivia Rodrigo to encourage young people to get vaccinated, The Wall Street Journal reports.
UPDATED: Tuesday, July 13 at 9:00 a.m.
The European Union’s drug regulator is reviewing data provided by Johnson & Johnson about a rare nerve disorder called Guillain-Barre syndrome linked to its single-shot vaccine, a spokesperson told Reuters. The review comes just after the FDA added a warning to J&J’s fact sheet and four days after the European Medicines Agency (EMA) included a similar warning for AstraZeneca’s jab.
The developers of Russia’s Sputnik V have repeatedly failed to provide key data to European regulators, sources told Reuters. Omitted information includes manufacturing and clinical data that's necessary to issue an approval.
Infectious disease expert Dr. Anthony Fauci told CNN that it’s plausible a third booster shot may be needed “across the board” in the future, or just for those who are most vulnerable, but “we don’t know that now.” However, the decision will be made through a “comprehensive study, not on the announcement from a pharmaceutical company."
Canada is donating 17.7 million doses of AstraZeneca vaccines to poorer nations through the vaccine sharing program COVAX, CBC reports. A top health official said the doses were surplus from its advance purchase agreement with the company and are no longer needed for the country’s inoculation campaign.
A small WHO study found that Gilead Sciences' Veklury, also known as remdesivir, and hydroxychloroquine didn’t significantly clear the virus from hospitalized COVID-19 patients or affect the degree of respiratory failure and inflammation over standard of care after 10 days. The study, an add-on from the WHO’s larger Solidarity trial published late last year, evaluated 181 patients hospitalized at 23 different facilities in Norway. Story
UPDATED: Monday, July 12 at 3:50 p.m.
The FDA plans to add a warning to Johnson & Johnson’s vaccine that says it may cause a rare neurological condition known as Guillain-Barré syndrome, the Washington Post reports. There have been 100 preliminary reports of the syndrome out of the 12.8 million people who’ve been vaccinated in the U.S. with J&J’s shot, mostly among older men.
The World Health Organization’s (WHO) top scientist warned countries against mixing and matching vaccines from different manufacturers, calling it a “dangerous trend” since there’s still not enough data.
French President Emmanuel Macron said vaccination will be mandatory for all of the country’s health workers, although the jabs won’t be required for the general public. France, which has dealt with anti-vaccine sentiment for years, is experiencing an uptick in infections amid the rise of the rapidly spreading delta variant, first found in India.
Diagnostics company Quidel snagged a CE mark for its combined COVID-19, flu and RSV molecular testing platform and the first assay panel for the platform, allowing it to be sold and used across Europe. The Savanna platform is a multiplex molecular analyzer that performs PCR tests to detect a targeted DNA or RNA sequence in less than 30 minutes. It comes less than a week after the FDA handed down a high-risk Class I label to Quidel’s recall of its Lyra PCR test for COVID-19. Story
UPDATED: Monday, July 12 at 9:15 a.m.
Pfizer will discuss the need for a third dose of its mRNA vaccine with top U.S. health officials, just days after the drugmaker claimed a booster would be needed. The company’s claim was met with immediate pushback from CDC and FDA officials, which said in a joint statement that Americans don’t need a third dose just yet. Meanwhile, infectious disease expert Dr. Anthony Fauci on Sunday said a third shot may be necessary, but it’s too soon to tell.
Gavi, the vaccine alliance, has inked two advance supply agreements with Chinese vaccine developers Sinovac and Sinopharm for up to 550 million doses through the first half of 2022. Through the agreement, 110 million doses will be made immediately available to COVAX, the vaccine sharing facility for poorer nations, Gavi said.
Israel will allow adults with weak immune systems to get a third shot of the Pfizer-BioNTech vaccine amid a growing number of infections from the fast spreading delta variant, first identified in India, Reuters reports. The country is still pondering whether to expand the use of a third shot to the greater public.
Italian biotech ReiThera said its experimental vaccine produced a strong immune response in phase 2 testing, the company said. The shot, dubbed GRAd-COV2, produced an immune response against the SARS-CoV-2 spike protein in over 93% of trial participants three weeks after the first dose, and a 99% response after a second shot. ReiThera said it plans to initiate phase 3 testing as soon as possible.
India’s rollout of Russia’s Sputnik V vaccine is on pause until Dr. Reddy’s Laboratories secures an equal amount of second shots to its delivery of first doses, Reuters reports. So far, Dr. Reddy’s has received about 3 million first doses but only 360,000 second shots.
UPDATED: Friday, July 9 at 4:45 p.m.
Faced with waning demand for COVID-19 testing, Abbott Laboratories has started laying off hundreds of workers at its diagnostics plants, reports ABC station WMTW in Portland, Maine. The company plans to let go 400 full-time employees at its locations in Westbrook and Scarborough, which are focused on the production of rapid antigen tests. Story
Humanigen said the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted its lenzilumab an expedited COVID-related rolling review, a speedy method that could see the drug on the U.K. market more quickly than the average drug. In late March, a phase 3 test of lenzilumab in hospitalized patients met its primary endpoint, a result Humanigen now hopes will help it gain approval in the U.K. Story
The CDC encouraged all U.S. schools to fully reopen in the fall, even if they can’t follow the agency’s guidelines. Those who aren’t fully vaccinated are encouraged to wear a mask, and students should maintain 3 feet distance. The CDC said schools should use local health data to determine when to tighten or loosen prevention measures.
UPDATED: Friday, July 9 at 9:30 a.m.
Pfizer and vaccine partner BioNTech said they're preparing a booster shot that will target the emerging Delta variant, first found in India, and added that evidence indicates the immunity from the pair's mRNA shot could wane following a second dose. The duo said that after seeing encouraging data from the ongoing trial of a third Comirnaty dose, they plan to file an application for a third shot with regulators in the coming weeks. But in a note sent out immediately following their announcement, the FDA and CDC jointly argued that Americans don’t need a booster shot just yet.
Meanwhile, the World Health Organization believes more data are needed to know whether a COVID-19 booster will be necessary, a spokesperson said. Specifically, studies would need to determine how long protection from the vaccines last and whether a booster would be beneficial at all, and for whom, the global health agency said.
India’s Hetero Labs is seeking an emergency use nod for Merck’s oral COVID-19 drug molnupiravir with local regulators after interim late-stage data showed the treatment reduced hospital admissions, led to faster recovery times early negative SARS-CoV-2 RT PCR results, Reuters reports. Merck inked production deals with several Indian drug manufacturers to expand the drug’s production, which has not yet scored regulatory approval.
The EU’s drug regulator found a possible link between the mRNA vaccines from Pfizer-BioNTech and Moderna and rare cases of heart inflammation, known as myocarditis and pericarditis. The European Medicines Agency (EMA) said the conditions should be listed as side effects, a month after a similar determination was made in the U.S.
The jabs from Pfizer-BioNTech and AstraZeneca are highly effective at preventing symptomatic infections among vulnerable people, according to Public Health England (PHE). Both shots were about 60% effective against symptomatic infections after one dose.
UPDATED: Thursday, July 8 at 3:45 p.m.
The Delta variant, first identified in India, can evade some of the neutralizing antibodies spurred by vaccines or through natural infection, and a single dose of the two-shot vaccines “barely” thwarted the mutation, according to a peer-reviewed study published in the journal Nature. However, two shots of the AstraZeneca or Pfizer-BioNTech shots still provide powerful protection, researchers found.
The Bill and Melinda Gates Foundation awarded the U.K.-based Exscientia $1.5 million to use its artificial intelligence technology to discover a new class of COVID-19 drugs through the COVID-19 Therapeutics Accelerator. The company said it’s designed a novel class of inhibitors targeting SARS-CoV-2’s main protease enzyme. The goal is to turn the novel small molecule inhibitors into a therapeutic development candidate.
The global death toll from the coronavirus has passed 4 million as wealthier nations begin to ease restrictions while other, poorer countries still vie for vaccine doses. The head of the World Health Organization, Dr. Tedros Adhanom Ghebreyesus, said the pandemic is now compounded by fast-moving virus mutations and “shocking” vaccine inequity.
UPDATED: Thursday, July 8 at 11:10 a.m.
Germany will give away all of its remaining AstraZeneca doses to poorer nations next month, Reuters reports. At least 500,000 will go toward the vaccine-sharing facility COVAX, while some doses will be given to countries in the Western Balkans, as well as members of the EU’s Eastern Partnership and Namibia. Germany has been relying on doses from Pfizer-BioNTech.
China’s Sinovac vaccine was less effective at preventing COVID-19 in Chile when compared with the mRNA jab from Pfizer and BioNTech, according to a new study, the first to pin the two vaccines against each other. While Sinovac’s shot was 66% effective at preventing COVID-19 in fully vaccinated adults, Pfizer’s was 93% effective. The study was conducted between February and May when two variants—alpha and gamma—were widely spreading.
The Tokyo Olympics will move forward without spectators after Japan declared a state of emergency in the area. The decision reversed the previous ruling that allowed either 10,000 people, or half of a venue’s capacity, to watch the games, which start on Monday.
COVAX aims to deliver 520 million doses to African nations this year once supply delays from India begin to ease, although that's not guaranteed, said the facility’s managing director, Aurelia Nguyen. The vaccine-sharing facility has delivered about 25 million doses to 44 African countries so far.
Sanofi and GlaxoSmithKline were awarded an approval from India to conduct late-stage clinical trials of their protein-based vaccine. The pair hope to score regulatory approvals by the end of this year and are testing the shot as a booster to the currently available vaccines. The trials in India will enroll about 3,000 adults.
UPDATED: Wednesday, July 7 at 3:45 p.m.
A study suggests that COVID-19 vaccines could be approved simply by assessing the levels of antibodies in vaccinated individuals, rather than requiring time-consuming phase 3 trials that examine efficacy. The study by AstraZeneca, Public Health England and Oxford compared the immune responses of 171 vaccinated people who developed symptomatic infections to 1,404 vaccinated people who were not infected. Those with higher levels of antibodies had stronger protection. Combining knowledge of immune biomarkers with immunogenicity and safety data could provide a reliable way to assess new vaccines, the researchers said.
The World Health Organization has recommended the use of IL-6 rheumatoid arthritis drugs—including Roche’s Acterma and Sanofi and Regeneron’s Kevzara—in combination with corticosteroids to reduce the risk of death in those with severe COVID-19. Along with the recommendation, the WHO implored manufacturers of these drugs to lower their cost to allow for more worldwide access. The move comes two weeks after the FDA approved the use of Actemra along with corticosteroids to treat those with severe COVID-19. Story
Embattled COVID-19 vaccine manufacturer Emergent is facing multiple investor lawsuits, including the most recent, brought by an Illinois-based police pension fund, which charges seven executives, including CEO Robert Kramer, and board members with insider trading. The suit claims that Kramer and others deceived investors to keep stock prices artificially high. In January and February of this year, Kramer sold his Emergent stock for $10.1 million, according to the suit. Story
VitriVax, which is developing a thermostable, single-dose vaccine platform, has received a Series A boost from Adjuvant Capital. The importance of technological advancement in this area has been demonstrated through the COVID-19 pandemic, where vaccination efforts have been hindered by cold-storage and two-shot requirements. Story
UPDATED: Wednesday, July 7 at 9:15 a.m.
The fast-spreading Delta variant, first found in India, accounted for more than half of new U.S. cases from June 20 to July 3, according to new CDC data. That’s up from roughly 30% for the three week period ending June 19.
President Joe Biden is urging all eligible Americans to get vaccinated against the virus, especially as the highly-infectious Delta variant runs rampant in vulnerable communities. Biden said the U.S. will work to boost vaccine availability in doctor's offices and at workplaces. Roughly 67% of American adults are now vaccinated against the virus, still shy of Biden’s 70% goal by July 4.
Innate Pharma will end the development of its anti-inflammatory drug avdoralimab in COVID-19 patients with severe pneumonia after a phase 2 study failed to meet its primary endpoints.
The Pfizer-BioNTech jab appears less effective against infections from the troublesome Delta variant, but it still remains highly effective against hospitalizations, Politico reports, citing early data from a study conducted in Israel. From June 6 to July 2, the shot prevented 64% of cases, a notable drop from the previous 94% reported through June 5.
India is expecting 3 to 4 million doses of mRNA vaccines from Pfizer-BioNTech and Moderna by August through the vaccine sharing facility COVAX, Reuters reports, citing two sources familiar with the matter. India has so far administered at least 358 million doses, giving a first shot to about 31% of its adult population.
UPDATED: Tuesday, July 6 at 3:55 p.m.
The European Union ordered 40 million additional doses of Johnson & Johnson's single-shot vaccine, a far cry from the 200 million additional shots that were offered under a contract between the company and the EU, Reuters reports, citing an EU Commission spokesperson. The EU didn’t name the countries that have ordered more doses. A J&J spokesperson confirmed the order and said discussions over future orders were underway.
Ocugen and partner Bharat Biotech have posted encouraging data from late-stage trials of their vaccine Covaxin, which already has restricted emergency use in India. In the latest readout, the vaccine posted a vaccine efficacy against mild, moderate and severe COVID-19 disease of 77.8%, with efficacy against severe disease coming in at 93.4%. The shot also hit 65.2% efficacy against the highly transmissible Delta variant, first found in India. Story
The World Health Organization has recommended two arthritis drugs from Roche and Sanofi to treat severe and critical COVID-19 patients. The recommendation comes after the anti-inflammatory drugs, Roche’s Actemra and Sanofi’s Kevzara, were found in a study with nearly 11,000 patients to cut the risk of death or need for ventilation, Reuters reports.
UPDATED: Tuesday, July 6 at 9:15 a.m.
South Korea is in preliminary discussions with Moderna and Pfizer to produce up to 1 billion mRNA doses, which could boost supplies in Asia, a senior official told Reuters. The country already has manufacturing deals with AstraZeneca, Novavax and Russia to produce their vaccines and an existing bottling and packaging deal with Moderna.
Britain will forge ahead with its plan to lift most coronavirus restrictions on July 19, but Prime Minister Boris Johnson is coming under fire for his decision to leave it up to the public to wear face coverings, the New York Times reports. Some are concerned that the rapidly-spreading Delta variant, first found in India, could put more vulnerable people at risk. Daily cases in the U.K. have increased more than 50% compared with the previous week.
India’s drug regulator has twice urged Pfizer to apply for emergency use in the country, although the drugmaker has not yet submitted its application, sources tell the Times of India. Meanwhile, doses of mRNA rival Moderna are set to arrive in India this week after it scored authorization last week.
Japan will ship out millions of additional AstraZeneca doses to neighboring Asian nations this week, including 1.13 million to Taiwan. One million doses each will be sent to Thailand, the Philippines and Vietnam this week, Japanese Foreign Minister Toshimitsu Motegi told reporters.
UPDATED: Thursday, July 2 at 9:45 a.m.
Johnson & Johnson said its vaccine produced “strong, persistent activity” against the troublesome Delta variant, first found in India, when studied in a small number of blood samples from vaccinated people in the lab. J&J also revealed that its single-shot vaccine generated an immune response that hasn’t waned for at least eight months following vaccination.
Germany is recommending people who’ve been given a first dose with AstraZeneca’s vaccine receive an mRNA shot for their second dose as a way to safeguard against the highly infectious Delta variant, according to German Health Minister Jens Spahn. It’s believed that the follow-up mRNA shot will provide better protection than two AZ doses, Spahn said.
The European Commission said it’s working out how to allow travelers who were vaccinated with the Indian-made version of AstraZeneca’s shot into its vaccine passport scheme, Reuters reports. Millions of Britons have been inoculated with the shot after it was approved in the U.K. earlier this year, but the European Medicines Agency (EMA) has yet to sign off.
Moderna has kicked off production of its vaccine at Recipharm’s site in Monts, France, following the approval from the European Medicines Agency (EMA) three weeks ago. The site is part of Moderna’s plan to double its drug substance manufacturing in Europe, the company said.
UPDATED: Thursday, July 1 at 3:45 p.m.
Despite a disappointing 48% vaccine efficacy readout in a key late-stage trial, German mRNA developer CureVac says it's forging ahead with a regulatory submission in Europe. Although its vaccine’s effectiveness hardly changed once a final analysis was submitted, the company believes it has shown some benefit among people 18 to 60 years old. In that subgroup, the trial linked the vaccine to an efficacy of 53%. Efficacy against moderate to severe disease was calculated at 77% in the subgroup. Story
Two doses of AstraZeneca’s vaccine prevent roughly 94% of deaths from the coronavirus in people aged 65 and older, according to a new Public Health England report. It’s thought that the figure comes from a point in time when the Alpha variant, first found in the U.K., was rapidly spreading, Reuters reports. It’s unknown what effect the worrisome Delta variant might have.
As Moderna preps a marketing strategy for its vaccine, its only commercial product so far, the biotech is hiring its first-ever chief brand officer. Kate Cronin joins this month from Ogilvy Health, where she was global CEO. Story
UPDATED: Thursday, July 1 at 9:50 a.m.
An experimental pill developed by Atea and Roche has shown promise against COVID-19 in a phase 2 trial. Interim results from 62 hospitalized patients demonstrate that AT-527 reduced the amount of virus in the blood. The medicine has yet to show it can alleviate symptoms or reduce fatalities. A phase 3 study is underway and should produce mid-stage data by the end of the year. Merck and Ridgeback are also in late-stage testing for their COVID-19 pill. Pfizer has an oral therapy in development, as well.
Pointing to positive trial data, Pfizer will seek emergency approval for use of its COVID-19 vaccine on children aged 5 to 11 by September or October. “With this data, we felt very comfortable to move down in age,” said Alejandra Gurtman, VP of vaccine R&D at Pfizer, during a Johns Hopkins-University of Washington-led virtual symposium discussing pediatric clinical trials. The vaccine is currently authorized for those 12 and older.
The Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries—a worldwide push that includes the World Bank Group, WTO, WHO and the IMF—met for the first time and said that it will act as a “war room to help track, coordinate and advance delivery of COVID-19 health tools to developing countries.” The group called on G20 countries to “embrace” a vaccination target of 40% in all countries by the end of 2021 and 60% by the end of the second quarter of 2022. The group also called on countries to contribute a combined 1 billion doses to the effort this year.
With cases rising because of the coronavirus’ Delta variant, the U.K. may have to take “extra precautions” after a lockdown ends on July 19, prime minister Boris Johnson said. The warning comes after the WHO cautioned Europe about an oncoming virus wave and the need for countries to maintain vigilance.
UPDATED: Wednesday, June 30 at 3:55 p.m.
Britain is preparing to administer booster shots to its most vulnerable citizens, such as the elderly, as early as this September, Reuters reports. While an official decision over when a booster would be necessary hasn’t been made, officials said they would plan ahead as a precaution. Britain has administered first doses to 85% of adults.
Switzerland said it will give 4 million AstraZeneca doses it had reserved to the vaccine sharing program COVAX, a million more shots than previously expected. AZ’s shot hasn’t been authorized in Switzerland, and the country is now relying on mRNA vaccines from Pfizer-BioNTech and Moderna.
Moderna has earned the European Medicine Association's (EMA) approval to brand its vaccine as “Spikevax." With the nod in the EU, Moderna's Spikevax joins Pfizer and BioNTech’s Comirnaty and AstraZeneca’s Vaxzevria with European brand-name approvals. None of the names are approved in the U.S., though, because the vaccines are still under emergency use authorization rather than bearing full FDA approvals. Story
Scientists at the University of Cambridge have identified 200 approved drugs using computational analyses as possible candidates for repurposing against COVID-19 and validated two of them in early tests. The two drugs, antimalarial therapy proguanil and rheumatoid arthritis medication sulfasalazine, showed they could inhibit the replication of the virus in both monkey and human cell lines, according to a new study published in Science Advances. Story
UPDATED: Wednesday, June 30 at 9:00 a.m.
China’s Clover Biopharmaceuticals inked a supply deal with the vaccine sharing program COVAX for up to 414 million doses of its protein-based shot, which is still in late-stage trials. The company plans to supply an initial 64 million doses in 2021 if given the go-ahead from the World Health Organization (WHO). Clover estimates its vaccine could launch by the end of this year.
China’s Sinovac said its vaccine was safe and effective in an early-phase trial studying the shot in children aged 3 to 17. The study, published in the Lancet, enrolled 552 kids and tested two different low-to-medium doses. Researchers found that kids in the medium-dose arm had a stronger immune response than those in the low-dose group.
The European Union announced a portfolio of five pandemic therapeutics—four antibodies and a repurposed rheumatoid arthritis drug—that it will push to the forefront as the bloc vies for at least three new full authorizations by the end of the year. The list includes Eli Lilly’s immunosuppressant baricitinib and Lilly’s combo treatment with etesevimab, as well as antibodies from Regeneron, Celltrion, GlaxoSmithKline and Vir Biotechnology. The portfolio is set to grow to ten by October. Story
The former Trump administration’s Operation Warp Speed will be getting a permanent home within HHS, although it will go under a new name: the Countermeasures Acceleration Group (CAG), STAT News reports. The program certainly won’t look the same as COO Gus Perna plans to retire this summer, although HHS will “continue to rely on its important functions to respond to this pandemic as well as better prepare for future threats,” a spokesperson told STAT.
So far, the globe has administered just over 3 billion vaccine doses, according to a count from Johns Hopkins University, but 11 billion will be needed to reach herd immunity, Duke University researchers tell the New York Times. That will be enough to inoculate roughly 70% of the global population and thwart the virus’ spread.
UPDATED: Tuesday, June 29 at 3:40 p.m.
A higher than expected number of military members reported cases of heart inflammation following vaccination with the mRNA shots from Pfizer-BioNTech and Moderna, a new study published in JAMA found, though the events are still rare. A total of 23 men with a median age of 25 reported chest pain four days after vaccination. Seven received Pfizer’s shot while 16 were given Moderna’s, the study said.
Health officials in L.A. County are recommending all residents, even those who are vaccinated, wear face coverings when in indoors because of the highly transmissible Delta variant, first found in India, circulating in the area. The county said nearly half of all sequenced cases for the week ending June 12 were the Delta variant. The masks are meant to help those who aren’t vaccinated or those who haven’t finished their regimen.
Abbott Laboratories received the go-ahead to make its Panbio rapid antigen test even more widely available in Europe. The newly granted CE mark allows the at-home test to be sold directly to European consumers, regardless of whether they’re showing any COVID symptoms. Story
Unlike vaccines, some COVID-19 therapies have had a tough time fighting back emerging variants. Now, GlaxoSmithKline and Vir Biotechnology are applying those lessons to their solo agent sotrovimab. Backed by promising phase 3 data and lab results showing efficacy against a suite of virus variants including the lurking Delta variant, sotrovimab still has a big role to play in the pandemic, executives told Fierce Pharma and Fierce Biotech. Story
Ireland has dropped its age requirements for AstraZeneca and Johnson & Johnson’s vaccine, allowing anyone to get the shots as concerns around the Delta variant loom, Reuters reports. The nation first restricted the jabs to people under 50 following concerns of rare blood clots.
UPDATED: Tuesday, June 29 at 9:20 a.m.
India’s Cipla has been given the OK to import doses of Moderna’s mRNA vaccine for restricted emergency use in the country, CNBC-TV18 reported. It will be the fourth shot deployed in India, joining Russia’s Sputnik V, China’s Covaxin and AstraZeneca’s Covishield, as well as the first from the U.S.
Five generic drugmakers in India, including Cipla and Dr. Reddy’s Laboratories, said they will jointly conduct clinical trials of Merck’s oral therapeutic, molnupiravir, in non-hospitalized patients. The companies inked an agreement with Merck earlier this year to help expand production of the drug, which has not yet been approved or deployed. The trial, from June to September, is expected to enroll about 1,200 patients.
Moderna said lab-based in vitro studies of its mRNA shot found sera from those who were fully vaccinated showed activity against a handful of troublesome variants, including variations of the Beta variant, first found in South Africa, as well as lineages of the B.1.617 variant, known as Kappa and Delta, first found in India. The vaccine produced neutralizing titers against all the variants that were tested.
The Association of Healthcare Providers (AHPI) is in talks with the European Union to secure 100 million Johnson & Johnson shots for India, the Economic Times reports. Meanwhile, the U.S.-based drugmaker is trying to speed up the delivery of its vaccine, which hasn't yet been approved in India.
Supplies of Moderna’s mRNA vaccine in Southeast Asia, Hong Kong, Macau and Taiwan are nearly all claimed for the year, according to Zuellig Pharma, Moderna's supply partner in the region. The company’s CEO John Graham told Reuters that the supply deals struck now cover 2022, although there may be some availability toward the end of this year.
UPDATED: Monday, June 28 at 2:35 p.m.
While questions have long lingered over the benefits of mixing COVID-19 vaccines, a study from the U.K. found that a regimen containing one dose of the Pfizer shot and one AstraZeneca dose prompted strong immune responses, The New York Times reports. Administering the doses in either order should work, an investigator said.
As India battles its COVID-19 crisis, Dr. Reddy's Laboratories unveiled the launch of 2-deoxy-D-glucose, also known as 2-DG, as a treatment option. The company is supplying the product to the government and to hospitals nationwide. Officials granted the treatment an emergency approval in early May.
The COVID-19 situation in the U.K. has worsened in recent days, with officials reporting more than 22,000 new cases on Monday. In response, Hong Kong is temporarily banning incoming flights from the U.K.
Amid vaccine rollouts, international travel is picking up in parts of the world. But the Serum Institute of India is raising concerns that its vaccine, Covishield, is not recognized by European authorities. The company is asking the Indian government to get involved and urge EU officials to recognize the vaccine in their travel requirements.
UPDATED: Monday, June 28 at 9:25 a.m.
Despite the challenges shrouding AstraZeneca’s existing vaccine, the company said it’s forging ahead with a new shot, known as AZD2816, to tackle troublesome new variants. The new jab has minor genetic alterations to the spike protein based specifically on the so-called Beta variant, first found in South Africa. AZ has started administering the shot as part of a phase 2/3 trial in both vaccinated and unvaccinated people. Story
A third shot of the Oxford University-partnered AstraZeneca vaccine produced a strong immune response in early clinical trial participants, suggesting the jab could be used as a potential booster, Oxford researchers found in a new, non-peer reviewed study. The study examined 90 previous trial participants who were given a third shot about 30 weeks following their second dose. Andrew Pollard, director of the Oxford Vaccine Group, said evidence indicates a booster may not be immediately necessary given the shots should still work against current variants.
The U.S. will ship out its first doses of Pfizer-BioNTech vaccine to Peru as part of its efforts to donate 80 million shots by the end of the month, CNN reports, citing a White House official. The official didn’t disclose how many doses have been delivered as part of that pledge, but said the administration is "currently working through the final stages of clearing all domestic regulatory, legal, and operational hurdles.”
Merck is in talks with several drug manufacturers to provide voluntary licenses for its oral antiviral, molnupiravir, and it also plans to join the UN-backed Medicines Patents Pool (MPP), to expand global access to the investigational drug, Mint reports, citing Merck’s India managing director Rehan Khan. The drugmaker has already inked deals with eight Indian generic drugmakers to make the drug.
UPDATED: Friday, June 25 at 3:40 p.m.
The head of the World Health Organization, Tedros Adhanom Ghebreyesus, chastised more developed nations for vaccinating their less at-risk populations, such as kids, before sharing doses with poorer countries. The WHO chief pointed to Africa, which is experiencing a surge in infections and deaths, as other nations begin reopening their economies, saying the world is "failing." "The problem now is a supply problem, just give us the vaccines,” he said.
With a pair of troubling coronavirus variants on the rise, the U.S. is pausing the national distribution of Eli Lilly’s antibody combo of bamlanivimab and etesevimab until further notice, an HHS official said. In vitro assays have shown that antibodies, when paired together, "are not active against either" the gamma variant, first found in Brazil, and the Beta variant, first identified in South Africa, according to a release. Story
Gavi, the vaccine alliance has approved $775 million to help fund the delivery of COVID-19 vaccines to low-income nations over the next two years through COVAX, the shot-sharing facility. Gavi, which co-leads the facility alongside the World Health Organization, said it also aims to simplify operations and reduce its financial risks by requiring middle-income nations to pay for shots in advance.
UPDATED: Friday, June 25 at 11:10 a.m.
The European Union has approved a production line in Anagni, Italy, to manufacture doses of Johnson & Johnson’s single-shot vaccine. The site, operated by Catalent, will help fill and package the shot and is expected to help boost lagging supply across Europe, according to the European Medicines Agency (EMA).
Denmark still won’t deploy the vaccines from AstraZeneca and Johnson & Johnson after a new review of safety information found a definitive link between the shots and cases of a rare blood clotting disorder, Reuters reports. The country was the first to stop, and then completely ditch, using the shots. Denmark has since relied heavily on the Pfizer-BioNTech vaccine.
Roche’s Actemra has posted mixed results in COVID-19 clinical trials, but the FDA thinks the rheumatoid arthritis drug has shown enough benefit in some severe patients to deserve an emergency use authorization. The agency authorized Actemra to be used alongside corticosteroids for hospitalized patients who require some form of oxygen support. Story
Japan will send 2 million additional AstraZeneca doses to Taiwan and Vietnam and is currently working on shipping 1 million doses each to Thailand, Malaysia, Indonesia and the Philippines, Reuters reports. The move comes shortly after Japan met with other G7 nations. Together, the group pledged to donate 1 billion doses to poorer nations.
UPDATED: Thursday, June 24 at 3:40 p.m.
The World Health Organization predicts people most at risk from COVID-19, like the elderly, will need an annual booster shot to ward off troublesome variants, Reuters reports, citing an internal document. The document is set to be discussed at a board meeting with Gavi, a vaccine alliance, which co-leads the vaccine sharing facility COVAX. The document suggests boosters may be needed every two years for those not at risk.
The FDA approved its first antibody test that doesn’t use blood samples to check for evidence of a COVID-19 infection and instead relies on mouth swabs. Developed by Diabetomics, the rapid, lateral-flow diagnostic received an agency emergency authorization allowing it to be used at the point of care for adults and children. Designed to deliver a result within 15 minutes, the CovAb test also does not require any additional hardware or instruments. Story
The European Union expects countries in the bloc will receive about 900 million vaccine doses in the second half of the year, just short of the 1 billion it previously anticipated, according to internal documents seen by Reuters. The shortcomings are not expected to impact the EU’s goal of vaccinating at least 70% of adults by the summer, according to the document.
Almost all coronavirus deaths in the U.S. are among those who aren’t vaccinated as daily fatalities fall to less than 300 a day, according to an Associated Press analysis. The analysis found that breakthrough infections in those who were fully vaccinated accounted for fewer than 1,200 hospitalizations, or about 0.1%.
UPDATED: Thursday, June 24 at 9:06 a.m.
The U.S. FDA will “move rapidly” to add a warning about rare cases of heart inflammation, known as myocarditis and pericarditis, to the fact sheets that come with the Pfizer-BioNTech and Moderna vaccines. The move comes after an independent CDC panel determined a likely link between the shots and the heart inflammation cases cropping up in mostly young adults, especially men.
The National Institutes of Health has launched a study to evaluate the immune responses generated in vaccinated pregnant people. The study will enroll up to 750 people vaccinated with any of the FDA-authorized shots to determine “development and durability of antibodies.” While thousands of pregnant people have already been vaccinated, there’s still a lack of “robust, prospective” data, NIH said.
The U.S. will send 3 million Johnson & Johnson vaccine doses to hard-hit Brazil. The doses are part of the 80 million the Biden administration pledged to donate to other countries. Brazil has the second-highest pandemic death toll—over 500,000—behind the U.S.
Vaccine sharing program COVAX is far short of its goal of delivering 2 billion doses to poorer nations by the end of this year, spurring changes to its operations to reduce its financial risks, Reuters reports. Subject to board approval, the proposal would increase the facility’s focus on nations most in need while reducing the participation of rich nations, both as donors and recipients.
UPDATED: Wednesday, June 23 at 2:55 p.m.
Doctors advising the CDC have concluded that there is a likely link between cases of heart inflammation in young adults and adolescents who have received mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna. The CDC working group said that the risk of myocarditis or pericarditis is increased, especially in males and after a second dose. There have been more than 1,200 reported cases, most of them in people aged 16 to 24. Most have recovered and no deaths have been recorded.
Congressional investigators have asked AstraZeneca and Johnson & Johnson to produce all communications related to efforts to supervise their COVID-19 vaccine activities at an Emergent plant in Baltimore that has been under scrutiny for production errors. The lawmakers also asked the companies to produce all records related to their decisions to hire Emergent as a subcontractor.
Moderna is reaping vast rewards, especially from the United States, for quickly developing a COVID-19 vaccine. Details in a recent Department of Defense contract show that the company is receiving $16.50 per dose and that the U.S. has doled out a total of $8.44 billion for 500 million shots. Story
A new antibody study from NIH estimates that for every COVID-19 infection that was detected in the United States in the spring and summer of 2020, 4.8 cases slipped by undiagnosed. The result is a massive undercounting of hidden new cases. The report puts that figure at 16.8 million through July of last year. In addition, archived blood samples indicate that the virus likely arrived in the U.S. by December of 2019, long before it was considered an emergency. Story
Llamas are helping scientists understand how to develop weapons to defeat COVID-19 variants. An Ohio State University-led study identified two types of nanobodies that could bypass mutations and prevent the virus that causes COVID-19 from entering cells. The nanobodies, inspired by tiny antibodies made by llamas, were able to neutralize the alpha, beta and gamma variants of the virus, the researchers reported. Story
UPDATED: Wednesday, June 23 at 8:50 a.m.
An independent panel of CDC advisors are set to discuss cases of heart inflammation cropping up among some people vaccinated with the mRNA shots from Pfizer-BioNTech and Moderna. There have been over 300 reported cases of the conditions, known as myocarditis and pericarditis, reported among mostly young adolescents. The Advisory Committee on Immunization Practices (ACIP) will examine the cases and assess whether there’s a potential link.
A new study from Oxford University found the AstraZeneca and Pfizer jabs are still effective against the troublesome Delta variant, first found in India, according to results published in the journal Cell. However, researchers warned that the variants led to reduced neutralizing antibody capacity, which might cause some breakthrough infections.
Authorities seized counterfeit doses of the COVID-19 treatment remdesivir at U.S. airports that were headed to Mexico for distribution, The Wall Street Journal reports. Illicit versions of the treatment, made by Gilead Sciences, are arriving in the U.S. from Bangladesh and India and then sent to Mexico, sources told the Journal.
Novartis will help manufacture more than 50 million doses of the Pfizer-BioNTech vaccine this year at its site in Stein, Switzerland, which was recently approved by the European Union’s drug regulator. The Swiss drugmaker, which announced the partnership in January, previously said it planned to begin production in the second quarter with shipments starting soon after.
Pfizer CEO Albert Bourla said the company is in the final stages of striking a deal with India to make its mRNA vaccine available in the country. Speaking at the India-US Bio Pharma & Healthcare Summit, the Pfizer chief said he’s confident the company will produce 3 billion doses this year and another 4 billion in 2022.
UPDATED: Tuesday, June 22 at 4:05 p.m.
The Delta variant, first found in India, is the “greatest threat’ to the nation’s pandemic response, and its transmissibility is “unquestionably greater” than the original strain, White House chief medical advisor Dr. Anthony Fauci told reporters on a call. The infectious disease expert maintained that the currently deployed vaccines are effective against the troublesome variant.
Meanwhile, the White House acknowledged that it won’t reach President Joe Biden’s goal of administering at least one vaccine to 70% of adult Americans by July 4. However, top health officials said the Biden administration “succeeded beyond our highest expectations” to return the nation to pre-pandemic normal, NBC News reports.
In rapidly developing a COVID-19 vaccine—and a highly effective one at that—Novavax got the hard part right. But the logistics of manufacturing the vaccine has proven to be a more daunting task for the biotech, which still has yet to file for approval of the shot in the U.S. The delays will severely impact the vaccine’s uptake in the U.S., where demand has been met primarily by mRNA vaccine suppliers Pfizer and Moderna, as well as Johnson & Johnson's adenovirus-based shot, according to Nancy Jaser, a Pharma analyst at GlobalData. Story
UPDATED: Tuesday, June 22 at 9:25 a.m.
The European Commission will secure an additional 150 million Moderna vaccine shots next year, which could include doses that target troublesome virus variants, as well as shots for kids and boosters. The option was included in the EU’s second supply deal with the biotech.
Bharat Biotech’s Covaxin shot, currently one of three vaccines deployed in India, was 77.8% effective in a late-stage trial, sources tell ANI. The latest readout came after a committee under India’s drug regulator reviewed trial data. The results also come before the company’s "pre-submission" meeting with the World Health Organization (WHO) on Wednesday regarding the shot's global approval.
A U.S.-backed study examining how well recipients of Moderna’s vaccine spread the virus will be expanded to include a wider swath of young adults, the COVID-19 Prevention Network said. The study, which has included college students so far, will now recruit people aged 18 to 29, as well as those who have chosen not to receive the vaccine. The trial is aiming to enroll 18,000 participants.
The World Health Organization is urging countries to protect their most vulnerable citizens through vaccination as the fast-spreading Delta variant, first found in India, threatens to “pick off” the unprotected, CNBC reports. Top health officials have recently warned that the Delta variant is gaining steam in the U.S. It’s thought to be roughly 60% more transmissible than the Alpha variant, first found in the U.K.
UPDATED: Monday, June 21 at 3:29 p.m.
Ahead of BioNTech's annual investor meeting on Tuesday, international aid group Médecins Sans Frontières called on the company to "immediately and openly" share its vaccine tech with the developing world. BioNTech has developed a plan to bolster manufacturing in Africa, but MSF said the program needs to be "massively accelerated."
The U.S. doesn't plan to immediately ship AstraZeneca COVID-19 vaccine doses to developing countries. Instead, initial donations will come from the three authorized shots in the U.S., Politico reports. Previously, the Biden administration pledged a donation of 60 million AZ vaccine doses.
Tonix Pharmaceuticals is kicking off a development program for TNX-102 SL to treat long COVID syndrome, which is now known as Post-Acute Sequelae of COVID-19. As part of the work, the company plans a meeting with the FDA during the third quarter to help design a pivotal study.
UPDATED: Monday, June 21 at 9:29 a.m.
GlaxoSmithKline and partner Vir Biotechnology trailed other COVID-19 therapeutic players onto the market, but they're not backing down from the challenge. On Monday, the companies said their drug, sotrovimab, demonstrated a 79% reduction in hospitalization for more than 24 hours or death compared with placebo after 29 days. The U.S. National Institutes of Health has added the drug to its COVID-19 treatment guidelines, and the companies are working to produce millions of doses. Story
Gilead Sciences also touted new data on Monday. In real-world data from nearly 100,000 hospitalized patients, Gilead's antiviral Veklury was associated with lower death rates than investigators recorded in control groups.
Germany's financial regulator BaFin is looking into whether any CureVac insiders may have sold shares ahead of the company's disappointing vaccine data release last week, Reuters reports. After the company said its shot was only 47% effective in a phase 3 trial, shares plummeted by more than 50%.
After reports that Bruce Springsteen's Broadway show wouldn't accept proof of vaccination with AstraZeneca's shot, the production group in charge is now allowing anyone vaccinated with an FDA- or WHO-approved shot to attend.
UPDATED: Friday, June 18 at 3:44 p.m.
President Joe Biden said that the U.S. is headed for a “summer of joy and freedom” now that it’s surpassed 300 million shots administered, although the optimism comes as the U.S. surpasses 600,000 COVID-19. Biden also warned unvaccinated Americans that the Delta variant, first found in India and gaining steam in the U.S., leaves them “even more vulnerable.”
Just a week after the U.S. FDA instructed consumers to toss Innova Medical Group’s COVID-19 antigen test, the U.K. is doubling down on its use of the test. The U.K. Medicines and Healthcare products Regulatory Agency said it found no problems in its own assessment, which it carried out after the FDA delivered a warning letter to the company for pre-emptively delivering unreviewed products to a number of customers and making accuracy claims that did not match up with clinical data. Story
The World Health Organization warned that the Delta variant first found in India is becoming the dominant variant worldwide, CNBC reports. The strain is thought to be around 60% more transmissible than the Alpha strain, first found in the U.K., and has spread to more than 80 countries globally, the agency said. It already makes up about 10% of U.S. cases, according to the CDC.
AstraZeneca will have to use a plant in Britain to supply the European Union doses of its COVID-19 vaccine if it doesn’t meet its commitments to the bloc otherwise, a Brussels judge ruled. The EU had previously targeted the plant during legal proceedings against the drugmaker, arguing that it had not received any shipments from the site despite delays. AZ has maintained that the site was needed to supply the U.K.
Moderna is planning a major manufacturing push and will hire 155 more people to fill its expanded production and lab space in Massachusetts. The new commitment came with a $2.33 million tax incentive from the Massachusetts Life Sciences Center. Story
UPDATED: Friday, June 18 at 8:57 a.m.
The Biden administration will finish allocating the 80 million vaccine doses it’s pledged to donate in the coming days, and some of the supply has already been shipped, said Jeff Zients, the White House COVID-19 coordinator. The shots will be sent to designated countries once they’re prepared to accept them.
A Brussels judge ordered AstraZeneca to send the European Union 80.2 million doses by the end of September, well short of the EU’s request for 120 million vaccines by the end of June and 300 million by September’s end. The drugmaker said it “welcomed” the ruling and “looks forward to renewed collaboration” with the EU. The bloc launched legal proceedings against AZ in April after the company failed to deliver its expected amount of doses earlier this year.
As the U.S. and Canada debate how to reopen their borders to one another, concern is brewing among tourists from the North that their AstraZeneca shot won’t be recognized in the States. In one example, Bruce Springsteen is reopening a show on Broadway later this month to a live audience, but the event will only recognize FDA-authorized vaccinations. While seemingly small, experts tell CTV News they fear it could be just the beginning.
More than 300 Indonesian doctors and medical workers caught COVID-19 and dozens are hospitalized even after being vaccinated with Sinovac’s shot, Reuters reports. Kudus, Indonesia, is fighting back an outbreak largely thought to be driven by the Delta variant first discovered in India. The World Health Organization authorized China’s Sinovac shot last month after the vaccine showed 51% efficacy against symptomatic infections in clinical trials.
Delayed deliveries from the vaccine-sharing facility COVAX will force South Korea to mix-and-match first and second vaccine shots, Reuters reports. Roughly 760,000 people given a first dose with AstraZeneca’s shot will now be given a follow-up Pfizer jab. Some countries have already approved the mix-and-match method following blood clot concerns linked to AZ’s shot.
UPDATED: Thursday, June 17 at 3:55 p.m.
The U.S. government will pump $3.2 billion into a program to discover an antiviral pill that could thwart COVID-19 early in an infection, the Department of Health and Human Services said Thursday. The Biden administration wants the program, part of the American Rescue Plan, to have a longer-term impact to discover and create antivirals for other potential pandemic viruses. Those who are unvaccinated or immunosuppressed remain vulnerable to the virus and an oral pill would be critical to a “therapeutic arsenal,” a top U.S. health official said. Story
CureVac’s pandemic partners GlaxoSmithKline and Bayer said they’re sticking with the company as it finalizes its late-stage trial data, which produced “disappointing” results. The company reported its shot was just 47% effective against the disease in a key trial. GSK is working with CureVac to produce second-gen shots based on different mRNA technology, while Bayer is signed up to help with manufacturing for the original jab. Story
The European Medicines Agency (EMA), which approves drugs for the EU, said it would not impose a 50% efficacy threshold for COVID-19 shots, a potential boost to CureVac’s shot. The EMA’s decision departs from the U.S. FDA’s, which said it would require shots to reach at least 50% in clinical trials to earn the agency’s emergency nod.
UPDATED: Thursday, June 17 at 9:00 a.m.
Shares of Germany’s CureVac more than halved after the company’s COVID-19 vaccine flopped in late-stage testing, posting a 47% efficacy rate. That’s much lower than the near 95% efficacy its mRNA rivals Pfizer-BioNTech and Moderna reported late last year. CureVac blamed the disappointing read out on circulating variants, saying there were at least 13 among trial participants. CEO Franz-Werner Haas told the New York Times in an interview that the company still plans to submit its shot with the European Union’s drug regulator. Story
Just under 900 people in New York City were administered expired Pfizer-BioNTech vaccines, and now officials are scrambling to inoculate them with new shots, the Washington Post reports. A spokesperson with the city’s health department said there’s no safety risk associated with the expired doses, although their effectiveness is still in question.
Germany’s health ministry said the nation’s vaccine rollout is still on track despite the disappointing trial results from CureVac, Reuters reports. Germany had a supply deal with the biotech for 20 million doses of its mRNA shot.
Pfizer CEO Albert Bourla said he expects the globe to return to normal by the end of 2022, according to an interview with CNBC. The Pfizer chief said by that point, there should be enough doses for world leaders to inoculate their entire populations, though more developed countries will likely reach that point by the end of 2021.
Novartis CEO Vas Narasimhan told CNBC that pandemics have “been with us for centuries” and another is “probably bound to happen” in the future. The Swiss pharma chief said the solutions are clear, like monitoring for viruses moving from animals to humans and sharing information rapidly. However, maintaining pandemic response investments is a challenge.
For those in Australia, it’s more likely someone will miss a day of work following a shot of Pfizer’s BioNTech-partnered mRNA vaccine compared with AstraZeneca’s shot, according to an ongoing study from the National Centre for Immunisation Research and Surveillance (NCIRS). Roughly 23% of people who received a second shot of Pfizer vaccine reported missing routine duties the next day, compared with just 8.7% among those who were given a second dose of AstraZeneca’s shot. However, 17.7% of people reported missing a day of activities after a first dose with AZ's shot.
UPDATED: Wednesday, June 16 at 3:40 p.m.
Russia’s Sputnik V vaccine likely won’t score an approval from the European Union until September at the earliest because of a missed June deadline to submit data, sources tell Reuters. The bloc was originally scheduled to finish its assessment of the shot at some point in May or June. However, the Russian Direct Investment Fund (RDIF), which is in charge of selling the shot, maintained that the review was on track.
In a concern for those who are unvaccinated, U.S. COVID-19 cases with the Delta variant, first found in India, are “rapidly increasing,” Surgeon General Vivek Murthy told CNN. The CDC reports that the Delta strain, now considered a variant of concern, accounts for 10% of all U.S. cases.
Amazon has started selling its at-home COVID-19 test to the public online for anyone aged 18 and over without a prescription. The test, which costs roughly $40, comes with a nose swab and collection tube, as well as a specimen bag and a prepaid shipping label to ship the sample back to one of Amazon’s labs around the country. Story
UPDATED: Wednesday, June 16 at 9:10 a.m.
The FDA said it will release an additional batch of Johnson & Johnson vaccine drug substance made at Emergent BioSolutions’ troubled plant in Baltimore, Maryland, clearing the way for a total of three batches to be exported from the site. The agency said last week that it would OK two other batches after thorough review, although it didn’t disclose how many doses are in each batch. Sources familiar with the plans tell Reuters that the third batch contained about 14 million doses.
The U.S. will buy an additional 200 million doses of Moderna's two-shot vaccine. The agreement gives the U.S. the option to purchase other COVID-19 shots in Moderna's pipeline, which includes boosters. The latest deal brings Moderna's total U.S. commitment to 500 million doses, with 110 million expected for delivery this year and 90 million by the first quarter of 2022.
Regeneron’s COVID-19 antibody cocktail, a combo of casirivimab and imdevimab, reduced the risk of death among hospitalized patients whose immune system couldn’t fight the disease, a new U.K. study found. The study, which included 9,785 patients, showed that among those who had no natural antibody response, REGEN-COV reduced the risk of death by 20%.
Johnson & Johnson will likely miss its expected deliveries to the European Union for the second quarter after the bloc banned millions of doses over safety concerns, Reuters reports, citing an EU Commission spokesperson. The EU last week said doses sent from the Emergent plant in Baltimore wouldn’t be used out of an abundance of caution. J&J expected to deliver 55 million doses by the end of June but has only sent 12 million so far.
Moderna will partner with Magenta Investments, a pharmaceutical and healthcare company that’s part of an investment and industrial conglomerate in the United Arab Emirates (UAE), to distribute doses of its mRNA vaccine and subsequent booster shots in the UAE in 2022 and 2023.
UPDATED: Tuesday, June 15 at 3:46 p.m.
Novavax said its COVID-19 vaccine remained effective when administered alongside an already-approved influenza vaccine, suggesting simultaneous inoculations may be a viable strategy. The drugmaker enrolled 431 participants as part of a sub-study during phase 3 clinical trials for its COVID shot, with all recipients receiving an authorized Seqirus flu vaccine but only half receiving its pandemic shot. The researchers found the shot’s efficacy was consistent with the main study at nearly 90%.
A new antibody study from the National Institutes of Health found evidence of COVID-19 infections in five states weeks before officials reported the first cases, indicating the virus could’ve been infecting Americans as early as December 2019. When examining more than 24,000 blood samples between Jan. 2 and March 18, researchers found antibodies against SARS-CoV-2 from participants in Illinois, Massachusetts, Mississippi, Pennsylvania and Wisconsin.
When the Indian government increased the gap between the two AstraZeneca shots to conserve supplies, it did so without the recommendation from the scientific group it said OK’d the decision, three sources tell Reuters.
UPDATED: Tuesday, June 15 at 9:25 a.m.
AstraZeneca said its investigational antibody combo fell short in a study testing whether the drug can prevent people who have been exposed to COVID-19 from developing symptoms. However, excluding PCR-positive subjects from the study tipped the balance in favor of AZD7442. AZ's R&D head Mene Pangalos, Ph.D., said in a statement the company is “encouraged by the protection seen in the PCR-negative participants.” Pangalos pointed to upcoming readouts from two other clinical trials as events that will shape the role AZD7442 plays in the management of COVID-19. Story
Two doses of either the Pfizer-BioNTech or AstraZeneca vaccines are highly effective at keeping people infected with the Delta variant, first found in India, out of the hospital, according to new findings from Public Health England. The analysis included just over 14,000 COVID-19 cases with the Delta variant, 166 of whom ended up in the hospital. Pfizer’s shot was 96% effective against hospitalization after two doses while AZ’s was 92%.
Daiichi Sankyo said it will stop developing an inhaled drug, known as nafamostat mesylate, to treat COVID-19 patients. The company decided to pull the plug in light of “situations of ongoing non-clinical studies and the phase 1 trial.” Daiichi kicked off the clinical trials for the drug, typically used to treat pancreatitis, in March.
The Serum Institute of India, the world’s largest vaccine manufacturer by doses, is preparing to manufacture Novavax’s vaccine following the drugmaker’s positive late-stage results released on Monday, a government official said. Novavax inked a deal with the manufacturer last year and SII expects to produce about 1 billion doses in 2021.
UPDATED: Monday, June 14 at 4:15 p.m.
Batches of the Johnson & Johnson COVID-19 vaccine have been destroyed in South Africa because of potential contamination during manufacture at an Emergent plant in Baltimore. Aspen Pharmacare revealed the development on Monday. The batches, designated for the South African market, were in storage at the company’s site in Gqeberha, awaiting the outcome of an FDA review. The agency determined that 60 million vaccine doses, in storage in a variety of locations around the world, would have to be discarded. Aspen said that “within days” J&J will supply 300,000 vaccine doses for South African teachers. J&J also will replace the contaminated batches with compliant bulk substance.
The most vaccinated state in America, Vermont has relaxed most of its COVID-19 restrictions. More than 80% of Vermont residents have received at least one vaccine dose. Over the last three weeks, the state has reported just one death from the virus. Vermont is in contrast to Mississippi, where just 28% of the state is fully vaccinated.
In the week ending on June 3, only 2% of Americans who were tested for COVID-19 were positive, the lowest rate since the pandemic began, according to the CDC. During the winter surge, 13% of Americans who were tested showed positive results. The turnaround is a sign of progress as the county starts to reopen.
The FDA provided insight on its inspection of an error-prone Emergent plant in Baltimore that was cited for several violations in its manufacture of the Johnson & Johnson COVID-19 vaccine. Story
UPDATED: Monday, June 14 at 9:15 a.m.
Novavax said its COVID-19 vaccine posted a 90.4% efficacy in late-stage testing, setting up the company to submit the shot for an FDA nod in the third quarter. The Maryland-based company reported its vaccine achieved 100% efficacy at preventing moderate and severe disease. The vaccine was roughly 93% effective against virus variants, Novavax said. Story
The number of trade barriers on pandemic supplies have ticked up slightly, World Trade Organization Director General Ngozi Okonjo-Iweala said during a virtual U.N. forum, warning that the trend is going “in the wrong direction.” The WTO chief said the barriers need to come down so medical goods and supplies can be moved faster. There were 109 trade restrictions at the beginning of the pandemic last year, which fell to 51 but has since risen to 53.
U.K. Prime Minister Boris Johnson is set to extend England’s coronavirus restrictions by another four weeks following a planned June 21 lifting, the BBC reports, citing government officials. Health experts have called for the delay so more vaccines could be administered as a troublesome variant dubbed Delta, first identified in India, continues to infect more people.
Pfizer CEO Albert Bourla said he’s confident the company’s BioNTech-partnered mRNA vaccine will protect against the Delta variant first found in India, according to an interview with CBS news. Bourla added that there’s likely no need for a new vaccine since the drugmaker’s original shot should cover the variant.
The heads of the world's seven richest countries, or G-7, have agreed to donate 1 billion doses to poorer nations over the next year. During closing remarks at a summit in England, President Joe Biden said the U.S. would be responsible for roughly half of the pledged amount.
A top European Union official has maintained that the benefits of AstraZeneca’s vaccine outweigh its risk in people of all ages, clarifying comments previously reported in the Italian newspaper La Stampa, Reuters reports. Marco Cavaleri, head of the EMA’s vaccine strategy, was earlier quoted saying that countries should avoid the vaccine for all ages amid fears of blood clots.
UPDATED: Friday, June 11 at 3:50 p.m.
Federal regulators told Johnson & Johnson to discard roughly 60 million doses of its single-shot vaccine manufactured at the troubled Emergent BioSolutions factory in Baltimore, Maryland, because of possible contamination, The New York Times reports. The FDA said the company could ship out drug substance worth 10 million doses to the U.S. and other countries, but it will have to come with a warning that says regulators can’t guarantee Emergent followed good manufacturing practices. Story
Meanwhile, the European Union doesn't expect Johnson & Johnson to meet its goal of delivering 55 million shots to the bloc by the end of June, Reuters reports, citing an EU official. The EU switched its expectations after its drug regulator said earlier in the day that doses sent from the Emergent BioSolutions factory in the U.S. wouldn't be used out of precaution.
The FDA issued a scathing warning against Innova Medical Group’s rapid COVID-19 antigen tests following “significant concerns” about its accuracy, telling consumers to return their kits or place them in the trash. The test has not been authorized or approved by the FDA for use in the U.S. But during inspections of the company’s California facilities in March and April, FDA investigators said they found the test was already being sold and distributed. Story
More than 26 million doses of routine vaccines were missed from January through November of last year, according to a claims analysis by Avalere Health commissioned by GlaxoSmithKline. The analysis is one of the first to place a number to the fear held by many public health officials that routine immunizations fell during the pandemic. Story
UPDATED: Friday, June 11 at 10:20 a.m.
A CDC advisory committee will hold an emergency meeting next week to discuss rare reports of heart inflammation cropping up among people who've received the mRNA shots from Pfizer-BioNTech or Moderna. The agency said during an FDA meeting Thursday that it’s identified 226 cases of myocarditis or pericarditis that meet its “working case definition," although the agency hasn't linked the condition to the jabs yet.
The European Union’s drug regulator said people with capillary leak syndrome, a condition where plasma from blood vessels leaks into neighboring body cavities and muscles, should not be vaccinated with AstraZeneca’s vaccine. Additionally, the condition should be labeled as a side effect after the European Medicines Agency (EMA) reviewed six cases among women. Half of them had a history with the condition and one of them subsequently died, the EMA said.
The EMA said it’s aware that a batch of active substance for Johnson & Johnson’s vaccine was cross contaminated at Emergent BioSolutions’ manufacturing site in Maryland. While it’s believed batches of the vaccine released in the EU are not affected by the mix up, the drug regulator suggested not releasing vaccine supplies with the active substance made around the same time as the Emergent snafu.
A manufacturing site in Monts, France, has been given the EU's approval to produce Moderna’s COVID-19 vaccine. Swedish pharma Recipharm will operate the facility. Meanwhile, the mRNA developer announced separately that it will partner Tabuk Pharmaceutical Manufacturing Company to sell its vaccine and future boosters in Saudi Arabia.
UPDATED: Thursday, June 10 at 3:30 p.m.
The FDA extended the shelf life for Johnson & Johnson’s vaccine from three months at refrigerated temperatures to four and a half, the drugmaker said. The move comes as millions of doses were set to expire by the end of the month. A stockpile of the shots accumulated after the U.S. paused the shot’s rollout in April amid concerns over rare blood clot. Meanwhile, the U.S. will pause shipments of J&J's vaccine while it works through the backlog, The Wall Street Journal reports. Story
The CDC said it’s seen a higher-than-expected number of heart inflammation cases among young men who’ve received two shots from either Pfizer-BioNTech or Moderna. The agency had previously been monitoring for cases of myocarditis or pericarditis through its adverse event reporting system after similar cases were first identified in Israel. The CDC has yet to link the cases directly to the vaccines.
Amazon received the FDA’s clearance to sell its COVID-19 diagnostic test directly to consumers. The agency’s nod allows the company to sell its Real-Time RT-PCR test to anyone 18 years or older, regardless of whether they have a prescription or are displaying symptoms. Story
UPDATED: Thursday, June 10 at 9:15 a.m.
Moderna said it’s seeking an emergency nod from the FDA for its vaccine in adolescents aged 12 to 17. The company said the filing was based on its late-stage trial in teens, which didn’t find any COVID-19 cases among those who received the vaccine. The company is also seeking a similar authorization in the EU.
The U.S. is reportedly in discussions with Moderna to supply its mRNA vaccine to other countries in what could be a similar deal the Biden administration reached with Pfizer, a person familiar with the matter told CNBC. The biotech told Fierce Pharma that it’s “interested in the possibility of partnering with the U.S. Government to potentially provide additional doses of Moderna’s COVID-19 vaccine to help address the pandemic in low- and middle-income countries.”
The European Union did not exercise an option to buy 100 million Johnson & Johnson single-shot vaccines, and it may donate another 100 million optional shots, three sources tell Reuters. The EU originally ordered 200 million doses of the vaccine with the option of ordering an additional 200 million. J&J’s jab in the EU has been hobbled by safety concerns and delayed deliveries.
A new study found people who received the AstraZeneca-Oxford vaccine are at higher risk of a bleeding disorder known as immune thrombocytopenic purpura, or I.T.P., although the shot’s benefits still outweigh its risks, researchers said. The condition, which can cause bruising or serious bleeding, was estimated to occur in 1.13 out of 100,000 doses administered. The study evaluated 2.53 million people vaccinated in Scotland who received a shot from AZ or Pfizer. No link was found with the mRNA jab.
Teens and adults missed over 26 million doses of recommended vaccines between January and November last year, a “sustained” drop compared with the prior year, according to a new claims-based analysis commissioned by GlaxoSmithKline and conducted by Avalere Health. Despite warnings of a “twindemic,” influenza immunizations declined year-over-year.
UPDATED: Wednesday, June 9 at 3:30 p.m.
The Biden administration is reportedly buying an additional 500 million Pfizer vaccine doses to donate to the rest of the world, people familiar with the plans tell The Washington Post. President Joe Biden is set to make the announcement at a G-7 summit meeting this week in Britain. The administration had previously pledged 80 million doses for donation by the end of June.
The World Trade Organization has agreed to begin formal negotiations on a plan that would supply poorer nations with COVID-19 vaccine supplies, although members seem to disagree over a controversial suggestion to waive IP rights for the shots, Reuters reports. Members will meet next week to outline a plan for the negotiations and will issue a report on their progress by late July.
The Czech health ministry has recommended only those aged 60 and older receive the shots from AstraZeneca and Johnson & Johnson due to concerns of rare but serious blood clots linked to the shots.
UPDATED: Wednesday, June 9 at 9:05 a.m.
The European Union and the U.S. are reportedly set to reduce export restrictions on pandemic vaccines and drugs at a meeting early next week, according to a draft document reviewed by Reuters. Officials will also try to boost global vaccine and drug production by "encouraging voluntary sharing of knowhow and technology on mutually-determined terms," the report says. The U.S. has backed patent waivers for COVID-19 vaccines, while the EU has opposed the idea.
Merck has inked a deal with the U.S. for roughly 1.7 million doses of its COVID-19 therapy molnupiravir, developed alongside Ridgeback Biotherapeutics, for about $1.2 billion. The drug, which is still in late-stage testing, is an oral capsule designed for non-hospitalized patients with at least one risk factor for severe disease.
The CDC has eased travel recommendations for more than 110 countries just a month and a half after advising Americans not to travel to most parts of the world, The Washington Post reports. The agency said it would take 58 countries out of a level four “do not travel” category and bump them down to level three, “reconsider travel.” Mexico, Canada, Japan, France, Italy, Spain, Greece and Switzerland are no longer labeled “do not travel.”
A pharmacist in Wisconsin who pleaded guilty for trying to ruin vials of the Moderna vaccine last December because he was skeptical of them has been sentenced to three years in prison, the U.S. Justice Department said. Steven R. Brandenburg, 46, pleaded guilty to two counts of attempting to tamper with consumer products “with reckless disregard for the risk that another person would be placed in danger of death or bodily injury.” Late last year, Brandenburg purposefully removed a box of the mRNA vaccines during two successive night shifts, and later placed them back into the refrigerator for patient use after sitting out for several hours.
At least 400,000 AstraZeneca doses shipped to Indonesia, some through the global vaccine sharing facility COVAX, are set to expire by the end of June, a spokesperson with the Health Ministry said. The news comes as Indonesian President Joko Widodo pushes for one million vaccinations per day by July, opening the shots up to anyone aged 18 and older.
UPDATED: Tuesday, June 8 at 3:45 p.m.
A Cleveland Clinic study revealed that individuals who have been infected with COVID-19 gain no additional benefit from vaccination. The study included more than 52,000 employees of the clinic and showed no difference in incidence of infection between three groups—those who were previously infected, those who were vaccinated and those who were infected and later vaccinated. There was no data compiled on the duration of protection for the different groups.
Because it doesn’t have enough mRNA-type COVID-19 vaccines in stock, Australia will not follow the lead of Canada, which is offering individuals a mix of the mRNA- and adenovirus-type COVID-19 vaccines. Canada's drug regulator has ruled that a mix of the two vaccine types can boost antibodies more than two shots of one type. Some countries in Europe also are offering a mix of the adenovirus type, such as the AstraZeneca vaccine, and the mRNA type, such as the Pfizer-BioNTech and Moderna vaccines.
Firefighters were summoned after a generator ignited at a Pfizer facility in Andover, Massachusetts, which is manufacturing COVID-19 vaccines. The fire was extinguished within an hour, with no interruption of production. “No operational or environmental impacts occurred,” Pfizer told the Boston Globe.
UPDATED: Tuesday, June 8 at 10:15 a.m.
The U.S. is sitting on millions of unused Johnson & Johnson doses set to expire this month after officials paused the jab’s rollout in April over blood clot concerns, causing an unexpectedly large stockpile, The Wall Street Journal reports. The shot’s pause led to looming concerns about safety and caused many to cancel their appointments. Just over half of the 21.4 million distributed J&J shots have been administered, according to CDC data.
The European Union’s drug regulator doesn’t plan on making a decision on CureVac’s COVID-19 vaccine before August, a source at Germany’s health ministry told Reuters. The German biotech previously aimed to secure approval as early as May. CureVac signed a supply deal with the EU for up to 405 million doses of its mRNA vaccine, but it has yet to score an authorization.
Pfizer has begun dosing kids aged 5 to 11 with its BioNTech-partnered vaccine as part of a late-stage trial, CEO Albert Bourla said in a tweet. Bourla said the company is "grateful for the enthusiasm we have been seeing in response to the trial." The company plans on testing its vaccine in kids as young as 6 months old.
Aspirin doesn’t improve someone’s chances for survival if hospitalized with severe COVID-19, according to results from a large British study. Aspirin is a blood thinner used to reduce the chance of clots in other diseases, researchers said, so “it is disappointing that it did not have a major impact for these patients.”
AGC Biologics announced a partnership with Pfizer-BioNTech to supply plasmid DNA (pDNA) starting material for the pair’s COVID-19 vaccine. The CDMO said it will manufacture the pDNA at AGC’s Heidelberg, Germany facility.
UPDATED: Monday, June 7 at 3:40 p.m.
An analysis by Connecticut-based data and drug development specialist Phesi shows that obesity is the most significant risk factor predicting severe cases of COVID-19 in people under age 40. The study included more than 166,000 people from 56 countries.
Translate Bio, a developer and manufacturer of mRNA therapeutics, has achieved a milestone related to its collaboration with Sanofi. Reaching the standard will allow Translate to collect $50 million from Sanofi for support of a phase 1 clinical trial for its influenza vaccine candidate. Translate entered the agreement with Sanofi to develop up to five mRNA vaccines, including one targeting COVID-19.
Indianapolis-based CDMO Exelead has delivered its first batch of Pfizer-BioNTech COVID-19 vaccine. The company expects to add 50 new jobs as part of the new collaboration. Exelead specializes in the manufacture of products that use liposome, lipid nanoparticle and pegylation technologies.
A Gallup poll shows that 76% of Americans are vaccinated or plan to be and that the rate has steadily risen since September of 2020, when only 50% of Americans said they would be inoculated. The poll, however, also reveals that roughly 1 in 5 in the U.S. will not seek vaccinations. Of those who said they would not seek them, 78% said they were unlikely to reconsider.
After promising lab results on hamsters, Swiss biotech Polypfor is considering its late-stage breast cancer candidate, balixafortide, as a COVID-19 treatment. A proof-of-concept study will be needed to initiate a phase 2 trial in COVID-19 patients. Story
UPDATED: Monday, June 7 at 9:00 a.m.
Johnson & Johnson’s vaccine rollout in the U.S. has stalled as overall demand for COVID-19 inoculations among Americans falls and safety concerns over rare blood clots cloud the company’s shot, Reuters reports. Fewer than 650,000 Americans were vaccinated with J&J’s shot the week ending May 25, down from nearly 3 million leading up to its pause, according to CDC data. The news agency reports that close to half of the 21 million doses produced for the U.S. are unused.
Moderna said it's seeking approval for its mRNA vaccine in adolescents as young as 12 years old in the European Union and Canada. The company said its filings with the European Medicines Agency (EMA) and Health Canada were based on a late-stage trial in teens, which didn’t find any COVID-19 cases among those who received the vaccine. Moderna has previously said it plans to submit a similar filing in the U.S. in early June.
Doctors are getting better at detecting and treating a rare but serious blood clotting syndrome linked to AstraZeneca’s vaccine, The Sydney Morning Herald reports. While it appears that more cases of the syndrome, known as thrombosis with thrombocytopenia (TTS), are arising, treatments have also rapidly improved. Doctors have responded to TTS by using injections of antibodies taken from blood donors.
In a letter ahead of a meeting with the world’s richest nations, 100 former presidents, prime ministers and foreign ministers of various countries urged the group to pay for global vaccine supply, Reuters reports. The group of G7 countries, which includes the U.S., and other meeting attendees could help prevent the virus from mutating and reemerging as a global threat by paying what would amount to $30 billion a year for two years, the letter says.
As the U.S. pushes toward its COVID-19 vaccination goal, the Biden administration is already eying the much larger task of helping vaccinate the world. Speaking with The Wall Street Journal, Jeffrey Zients, the U.S. coronavirus response coordinator, said his team will channel the "same wartime response to the global effort that drove our domestic progress.”
UPDATED: Friday, June 4 at 3:56 p.m.
Canada has negotiated an option for 3 million more Pfizer COVID-19 vaccine doses, Reuters reports. An impressive 65% of people 12 and older in the country have received at least one shot, and Prime Minister Justin Trudeau said Canada is on track to vaccinate all individuals who want a vaccine by September. The latest batch of Pfizer doses will arrive in September.
Stemirna Therapeutics, which set up shop in 2016, has raised $188 million to bankroll its mRNA COVID-19 vaccine work. Sequoia Capital China co-led the financing with backers including WuXi AppTec and OrbiMed. The vaccine is expected to be effective against variants and is in midstage development, CEO Li Hangwen, M.D., Ph.D., said in a statement. Story
UPDATED: Friday, June 4 at 9:05 a.m.
The U.K. approved the Pfizer-BioNTech shot for 12- to 15-year-olds, following similar moves from the European Union, the U.S. and Canada. The U.S. is already inoculating teens in that age group while France and Germany said they will start this month, Reuters reports. Britain’s Joint Committee on Vaccination and Immunisation (JCVI) will now have to sign off on the approval.
The National Institutes of Health said its researchers may have discovered a new oral antiviral, known as TEMPOL, that can prevent the virus from replicating. The drug could help prevent severe disease if given early enough in someone’s infection, although more clinical trials are needed, researchers said.
Regeneron Pharmaceuticals announced the FDA authorized a lower 1,200 mg dose of its COVID-19 antibody cocktail developed alongside Roche, half the amount that was originally authorized. Regeneron said while the treatment should be administered through an intravenous infusion, an injection could work when an infusion isn’t feasible. The drug is used to treat mild-to-moderate COVID patients who are at risk of progressing to severe disease.
The White House terminated a part of the Defense Production Act that would require shot developers like AstraZeneca, Sanofi and Novavax to prioritize orders with the U.S. Although those vaccines haven’t passed muster with the FDA yet, the move will allow the companies to fulfill other orders first.
Taiwan's vaccine supply more than doubled following a donation of 1.24 million AstraZeneca doses from Japan, Reuters reports. Taiwan is facing a spike in infections but has vaccinated just 3% of its population. Meanwhile, Japan secured enough doses from AZ, Pfizer and Moderna to cover its entire population.
UPDATED: Thursday, June 3 at 3:20 p.m.
The Biden administration announced it would give the vaccine sharing facility COVAX about 19 million doses, or 75%, of the first 25 million shots the U.S. had previously pledged in donations. Six million of the COVAX doses will go toward countries in Central and South America, while 7 million will go to Asian nations and 5 million toward African countries. The remaining 25% of America’s total donations will go directly to neighboring countries and those experiencing surges.
The European Union purchased roughly 55,000 doses of the monoclonal antibody cocktail developed by Regeneron and Roche, the bloc’s first purchase of the treatment, Reuters reports. Roche told the news agency that the deal was made in April but contract details weren’t immediately made public. The deal will cover 37 countries, including Britain and other non-EU countries. The drug has yet to receive authorization from Europe's drug regulator.
The U.S. will send Mexico 1 million doses of Johnson & Johnson's single-shot vaccine, President Andres Manuel Lopez Obrador announced after speaking with U.S. Vice President Kamala Harris. The U.S. has faced pressure to share some of the doses it secured through supply contracts to other countries.
The Delta virus variant first found in India is now the dominant strain in England and might have an increased risk of hospitalization compared with previous strains, although more data is needed, according to Public Health England. Up until now, the Alpha strain first found in the U.K. was the dominant strain. Prime Minister Boris Johnson has said the Delta strain could derail England’s plan to lift lockdown restrictions on June 21.
UPDATED: Thursday, June 3 at 9:30 a.m.
India has signed a supply agreement with Biological E for 300 million vaccine doses and has paid an advance of $205.6 million, the first contract the country has inked for an unapproved vaccine, Reuters reports. India’s vaccine rollout has far lagged other large nations amid a crushing wave of infections.
Valneva has yet to successfully usher its inactivated COVID-19 vaccine across the regulatory finish line, but analysts still see reason to bet on the French vaccine specialist. The biotech's shot could bring in roughly $1.1 billion in 2022 through supply deals and more than $500 million in 2023, Jefferies analysts wrote in a note to clients. Story
AstraZeneca is in talks with the federal government to move its vaccine production from Emergent BioSolution’s plant in Baltimore to a factory owned by Catalent, The New York Times reports. Emergent was forced to stop producing AZ’s shots after a mix up ruined millions of Johnson & Johnson doses in May. Catalent is reportedly retrofitting a production line at the site in Harmans, Maryland, which is already producing some AZ shots.
The Serum Institute of India, the globe’s largest vaccine manufacturer, is reportedly in talks with federal regulators to manufacture doses of Russia’s Sputnik V vaccine, two sources tell Reuters. Six other manufacturers have already inked deals to produce roughly 1 billion doses of the shot.
Developed countries have already locked up doses from Pfizer-BioNTech and Moderna over the next two years, threatening to leave behind poorer nations, The Wall Street Journal reports. Pfizer has agreed to supply the EU with up to 1.8 billion shots through 2023, and will give Canada 125 million. Meanwhile, Australia, Switzerland and Israel already have agreements with Moderna for shots next year. Both companies have pledged doses to the vaccine sharing facility COVAX, which has struggled with manufacturing and delivery delays.
UPDATED: Wednesday, June 2 at 2:50 p.m.
The United Kingdom is in talks with AstraZeneca for supplies of a modified COVID-19 vaccine to target the "beta" variant of the coronavirus first identified in South Africa, health minister Matt Hancock said. In a speech ahead of a meeting of Group of Seven health officials, Hancock said the British government is involved in "commercial negotiations" with AZ for new variant doses, Reuters reports.
After a small number myocarditis cases were seen in recipients of Pfizer's COVID-19 vaccine, health officials in Israel said the cases were likely linked to the vaccine, Reuters reports. Pfizer said it was aware of the findings but that a causal link has not been established. Most of the cases were observed in young men.
Moderna has been busy making deals in recent days. Just as it inked two new manufacturing accords, the mRNA biotech signed on with UNICEF to supply 34 million doses of its shot to the worldwide COVAX facility in the fourth quarter of 2021. The agreement provides for an option of up to 466 million doses next year.
UPDATED: Wednesday, June 2 at 10:10 a.m.
The National Institutes of Health has started an early-phase clinical trial studying how well different COVID-19 vaccines work in people who have already been fully immunized. The mix-and-match study will include roughly 150 people who have been fully vaccinated with shots from Johnson & Johnson, Moderna or Pfizer. Infectious disease expert Dr. Anthony Fauci said while those shots offer strong protection,” the U.S. must “prepare for the possibility of needing booster shots to counter waning immunity and to keep pace with an evolving virus.”
Moderna has tapped Thermo Fisher Scientific with fill-finish, labeling and packaging duties for its mRNA vaccine at Thermo Fisher’s commercial manufacturing site in Greenville, North Carolina, according to a statement. Meanwhile, Swiss CDMO heavyweight Lonza, which has helped manufacture Moderna’s drug substance at a site in Visp, will also create a new line at its Geleen site in the Netherlands to manufacture lower-dose booster shots. Story
AstraZeneca said it will soon provide Thailand with 1.8 million locally manufactured doses of its vaccine. The company is working with Siam Bioscience, a firm owned by Thailand's king, to provide the nation with 6 million doses this month, Reuters reports. Thailand’s vaccine rollout, scheduled to begin early next week, comes amid its largest wave of COVID-19 infections yet.
After failing to obtain an FDA emergency nod last year, NRx Pharmaceuticals said it’s again seeking the agency's OK for Zyesami in critically ill COVID-19 patients suffering with respiratory failure. The company said patients treated with Zyesami in clinical trials were significantly more likely to be alive free of respiratory failure at 60 days compared with placebo. Story
CanSinoBIO is studying an inhaled version of its COVID-19 vaccine in a phase 2 trial, the company’s CEO Yu Xuefeng said. The company’s shot is already approved in China and authorized in a handful of other nations, such as Pakistan, Mexico and Chile.
UPDATED: Tuesday, June 1 at 3:20 p.m.
The World Health Organization authorized the vaccine from China’s Sinovac for people aged 18 and older. While the agency said it isn’t recommending an upper age limit, the shot’s effectiveness in people over 60 couldn’t be determined because of a small number of older clinical trial participants. The decision will pave the way for the shot's deployment in poorer nations through the global vaccine sharing program COVAX.
Denmark is reconsidering its decision to exclude the jabs from Johnson & Johnson and AstraZeneca in its vaccination program following supply delays from Moderna and CureVac, Reuters reports. The country stopped using AZ and J&J's shots in April and May, respectively, following reports of rare but deadly blood clots among some recipients.
A Canadian panel that makes vaccine recommendations said people who’ve received a first dose with AstraZeneca’s jab can get a second shot from either Pfizer-BioNTech or Moderna, Reuters reports. One of the reasons for the mix-and-match guidance was concerns about rare and potentially fatal blood clots that have been tied to AZ’s shot, according to the group, pointing to a handful of European countries that have issued similar recommendations.
Abbott Laboratories projects steeper-than-expected declines in diagnostic sales as vaccination rates continue to climb and health authorities loosen up their guidelines. The testing giant slashed its diagnostics sales forecast by as much as $2 billion and cut its spending plans for the rest of the year. Story
UPDATED: Tuesday, June 1 at 10:05 a.m.
Moderna said it's seeking full FDA approval of its COVID-19 vaccine, which is currently under an emergency use authorization. The biotech said it started the rolling review process for a biologics license application (BLA) and will continue to submit data over the coming weeks with the request for a priority review, which would shorten the agency's time to make a decision.
India issued an emergency authorization for Eli Lilly’s combo bamlanivimab and etesevimab treatment to help treat mild-to-moderate COVID-19 patients. The drugmaker’s arthritis drug baricitinib has already been approved in India in combination with remdesivir for hospitalized patients needing supplemental oxygen.
The World Health Organization has prescribed names to troublesome coronavirus variants, which have so far appeared as a jumble of letters and numbers, Reuters reports. The four high-priority variants found in the U.K., South Africa, Brazil and India have now been assigned the Greek letters Alpha, Beta, Gamma and Delta, respectively.
India’s Biological E. has entered into a licensing agreement with Providence Therapeutics Holdings to manufacture doses of the Canadian biotech's mRNA vaccine, which is under development. Biological E., also under contract to manufacture Johnson & Johnson doses, said it expects to produce 600 million Providence shots in 2022 with a target capacity of 1 billion shots.
UPDATED: Friday, May 28 at 9:00 a.m.
The U.K. approved Johnson & Johnson’s COVID-19 vaccine, making it the fourth shot in available the country alongside AstraZeneca, Pfizer-BioNTech and Moderna vaccines. The U.K. has a supply agreement for 20 million J&J doses. Meanwhile, Mexico has also authorized J&J’s shot, although Deputy Health Minister Hugo Lopez-Gatell said there was no immediate plan to acquire doses because Mexico has “a decent supply with the other five vaccines.”
The FDA is said to be nearing a deal with Johnson & Johnson to reopen the Emergent BioSolutions plant responsible for manufacturing its vaccine, The Wall Street Journal reports. The FDA forced the plant to stop production because of unsanitary conditions that led to millions of ruined J&J doses. The agency could clear the plant as early as next week, according to the report.
China’s Sinopharm vaccines successfully prevented symptomatic infections by 72.8% and 78.1% when tested against placebo, according to results published in the U.S. medical journal JAMA. However, in a study including 40,382 people, nearly 85% of the participants were men and less than 2% were aged 60 and older. Sinopharm has been criticized for not sharing detailed findings from its late-stage trial. The shots have already been deployed in mostly poorer nations.
A heart inflammation condition known as myocarditis cropping up in some young people after vaccination appears to be very rare, and it’s still unknown whether the jabs are to blame, the FDA’s top vaccine official Peter Marks said. The CDC’s safety monitoring group said last week that it was evaluating the cases.
To speed up its vaccine rollout, India won’t conduct local trials for “well-established” COVID-19 vaccines, Reuters reports. The move is expected to expedite shots from Pfizer, Johnson & Johnson and Moderna as India continues to face a crushing wave of infections.
UPDATED: Thursday, May 27 at 3:30 p.m.
The United States intelligence community acknowledged that it has two theories on the origin of the coronavirus. Two agencies believe it emerged from human contact with infected animals. Another agency says that it could have emerged from a lab accident. The Director of National Intelligence did not divulge which theories belonged to which agencies. The DNI said that none of the agencies have sufficient evidence to support their theories as conclusive.
On the heels of posting impressive data from a phase 2 trial for their COVID-19 vaccine candidate, Sanofi and GlaxoSmithKline have launched a phase 3 trial and will be ready to manufacture the adjuvanted recombinant vaccine within weeks. The shot could be ready by the end of the year and is vital, the companies said, because a new vaccine is needed to combat emerging coronavirus variants. Story
The United States has granted emergency use approval to a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology. There's just one problem: The company doesn’t have a supply contract with the U.S. The IV-infused drug joins authorized therapies from Regeneron and Ely Lilly and is limited to patients who aren’t hospitalized but are at risk for progressing to a severe case of the disease. Story
The U.S. has restricted the use of Eli Lilly’s COVID-19 antibody treatment in six states where virus variants from Brazil and South Africa account for at least 10% of those with the disease. The states are Arizona, California, Florida, Indiana, Oregon and Washington. Previously, the FDA banned the use of the antibody, a combo of bamlanivimab and etesevimab, in Illinois and Massachusetts. Story
The Department of Justice is investigating an Eli Lilly manufacturing facility in New Jersey which has been cited for quality control issues and for alleged document tampering. The site in Branchburg produces Lilly’s COVID-19 antibody treatment. Part of the investigation revolves around the production of bamlanivimab, one of the two drugs Lilly uses in its antibody cocktail. Story
UPDATED: Thursday, May 27 at 9:50 a.m.
As questions swirl around the need for COVID-19 boosters, new research may aid health officials in making those forthcoming decisions. People who have had a COVID-19 infection and then a vaccine will likely not need boosters, studies say. People who have only had vaccines—and no prior infection—will likely need further protection from booster shots.
Researchers in Germany say they've identified the cause of rare blood clots among some AstraZeneca and Johnson & Johnson vaccine recipients, Reuters reports. Their lab work, which hasn't been peer reviewed, suggests the cold viruses used in those vaccine can in rare cases trigger the body to form clots.
The idea that the European Union would ink another supply deal with AstraZeneca is “nonsense,” a top EU official told CNBC. The problem isn’t with the quality of the vaccine, but the company’s failure to deliver the doses on time, Didier Reynders, the EU commissioner for justice, said.
Novartis and its partner, Molecular Partners, are kicking off a phase 2/3 study examining its antiviral drug, ensovibep, in adults with early-stage COVID-19 to see whether it can ward off severe disease and hospitalization. Novartis aims to enroll a total of 2,100 patients in the trial: 400 for the dose-finding phase 2 portion and 1,700 in the phase 3 part. Story
Roche's rheumatoid arthritis drug tocilizumab showed it could reduce the risk of death in patients with moderate-to-severe COVID-19–associated pneumonia with high C-reactive protein levels 90 days after treatment, according to a JAMA research article. The researchers said that by day 14, just 18% of patients who received the drug with CRP levels greater than 15.0 mg/dL died or required ventilation compared with 57% in the placebo group.
UPDATED: Wednesday, May 26 at 3:27 p.m.
The European Union’s drug regulator said it's investigating the death of a woman in Belgium who received Johnson & Johnson’s COVID-19 vaccine and suffered from a blood clot with low platelets. The European Medicines Agency (EMA) said it was the first report of a death linked to the vaccine, although three fatalities have been associated with the shot in the U.S., Reuters reports. Belgium has suspended the vaccine’s use in people aged 41 and younger following the death.
President Joe Biden said he’s tasked the U.S. intelligence community to intensify their investigation into the origins of COVID-19 and instructed them to report back to him in 90 days. The president said the two prevailing thoughts are that the virus emerged from an animal, or it was the product of a laboratory accident. However, there is not enough evidence to determine which scenario is true, he added.
Scientists at the University of Pittsburgh found that very low doses of a tiny antibody known as a “nanobody,” administered directly through the nose or by inhalation, could prevent and treat severe COVID-19 in hamsters, according to a new study published in Science Advances. The treatment, dubbed PiN-21, could offer an affordable, needle-free option for treating early infections of SARS-CoV-2. Story
UPDATED: Wednesday, May 26 at 9:05 a.m.
The U.S. FDA said it may no longer consider new emergency use authorizations for COVID-19 vaccines if the company hasn’t already initiated discussions with the agency. The news comes as half of adult Americans are now vaccinated against the disease. Novavax, Medicago and AstraZeneca have all started to correspond with the FDA over their shots.
A European Union lawyer asked a Belgian court to impose a fine against AstraZeneca for failing to deliver its contracted vaccine doses on time, Reuters reports. The EU is seeking $12.20 per dose for each day of delay. AZ had originally forecasted 300 million doses delivered by June, but now it’s expecting roughly 100 million.
COVID-19 vaccine makers have ratcheted up their lobbying and public relations efforts against the U.S.-backed patent waiver set forth before the World Trade Organization, The Wall Street Journal reports. Industry representatives have met with Biden administration officials and members of Congress in an effort to reverse the nation’s support for the move.
Japan’s Nipro Corp, which makes syringes and medical devices, has signed an agreement with AstraZeneca to supply the company’s vaccine in Japan. The nation has agreed to purchase 120 million doses of the two-shot vaccine.
UPDATED: Tuesday, May 25 at 3:45 p.m.
India’s Bharat Biotech said it submitted an application to the World Health Organization for an emergency use listing of its COVID-19 vaccine, known as Covaxin, and a regulatory approval could be granted as early as July. The company said it will seek regulatory approval in more than 60 countries, including the U.S.
Half of all adult Americans have now been fully vaccinated against COVID-19, the Biden administration said, marking a “major milestone” in the nation’s pandemic response. Meanwhile, at least 61% of adults have been given at least one dose, inching closer to President Joe Biden’s goal of at least 70% of adult Americans with one shot by July 4.
Several French social media sites say a communications agency has offered them money to spread negative publicity about Pfizer’s BioNTech-partnered COVID-19 vaccine, Reuters reports. French Health Minister Olivier Veran called the attempts “pathetic” and “irresponsible.”
Spain is expecting roughly 94 million Pfizer-BioNTech vaccines beginning this December through June 2023 as part of the European Union’s latest supply deal with the companies. The shipment would be twice the target population in Spain, where around 8.1 million people have already received a full course of vaccines, Reuters reports, citing a government spokesperson.
UPDATED: Tuesday, May 25 at 8:56 a.m.
Moderna’s vaccine posted 100% efficacy in a phase 3 trial studying the shot in adolescents aged 12 to 17. The study, which enrolled 3,700 participants and administered the two-dose vaccine to two-thirds of them, reported no cases among the vaccinated group and four among the placebo. The biotech plans to ask the FDA to expand its emergency listing next month. Story
An internal European Union document shows that the bloc plans to have more than a billion vaccine doses by the end of September, enough to immunize its entire eligible population, Reuters reports. The document takes into account deliveries from four drugmakers: Pfizer, Moderna, AstraZeneca and Johnson & Johnson. It didn't include doses from Germany's CureVac or France's Sanofi, which also hold supply deals with the EU. Those companies are still working to push their vaccines across the regulatory finish line.
Mexico will soon begin phase 3 testing for the COVID-19 vaccines from Sanofi and China's Walvax, the nation’s Foreign Minister Marcel Ebrard said. Mexico is also developing its own vaccine, known as Patria, which will enter phase two trials soon, he added.
Unlike other countries in the Americas, Cuba isn’t waiting for vaccine deliveries from the global program COVAX and has started inoculating citizens with its own shots, known as Soberana 02 and Abdal, Bloomberg reports. Abdal doses have been administered to more than 445,000 Cubans outside of phase 3 clinical trials, while Soberana will be soon to follow, President Miguel Díaz-Canel said last week, adding that the shots appear to be safe and effective.
UPDATED: Monday, May 24 at 2:10 p.m.
Pfizer's next-gen pneumococcal vaccine could be ready for a launch this summer, but with competition expected from rival Merck & Co., the company is looking for an edge. Now, Pfizer has started a co-administration study testing its pneumococcal vaccine candidate with a COVID-19 booster in adults 65 and older. If the trial succeeds, the two vaccines could potentially be administered together when people need their boosters.
After months of criticism from governments and others about AstraZeneca's pandemic work, CEO Pascal Soriot defended his company in a Financial Times interview. While there has been some fair criticism, he said, sometimes there are "armchair generals who have opinions about everything." AstraZeneca's work has saved tens of thousands of lives, he added.
Breathonix, a startup in Singapore, has secured a provisional authorization there for a 60-second COVID-19 breath test dubbed BreFence Go. Clinical trials found that the breathalyzer test achieved 93% sensitivity and 95% specificity in screening 180 study participants for the infection.
UPDATED: Monday, May 24 at 9:22 a.m.
After federal officials stopped distributing Eli Lilly's antibody combo in Illinois due to concerns about the P.1 variant, they're now stopping shipments of the drug regimen to Massachusetts. Officials say Regeneron's competing cocktail should retain activity against that specific variant.
The CDC is investigating reports of heart inflammation in young recipients of COVID-19 vaccines, The New York Times reports. The agency didn't offer many details and said the cases could be unrelated to vaccination.
Working to produce as many mRNA vaccine doses as possible, Moderna has inked two new manufacturing partnerships. In a deal unveiled Saturday, Moderna said CDMO Samsung Biologics will provide fill-finish capacity at a site in Incheon, South Korea. Separately, in an expanded collaboration, Aldevron plans to supply Moderna with plasmid DNA to help with production of the COVID-19 shot and other programs in Moderna's pipeline.
In its vaccine supply lawsuit against AstraZeneca, the European Union is setting out to convince a court that the situation warrants an order that AZ immediately provide missing doses, AP reports. AstraZeneca contends it has done its best to produce and deliver as many doses as possible.
UPDATED: Friday, May 21 at 3:25 p.m.
European Union officials persuaded the Biden administration to loosen export restrictions on materials CureVac needs to make its COVID-19 vaccine currently under development, sources tell Reuters. The German biopharma previously warned that U.S. export controls under the Defense Production Act were hurting its ability to predict short-term supplies.
What’s your vaccination status? That might be the new question among singles looking for love on popular dating apps, which have teamed up with the Biden administration to encourage more people to get vaccinated. The apps, such as Tinder, Bumble and Hinge, will provide users with perks like a vaccination badge on their profile and "premium content like boosts, super likes, and super swipes,” according to the White House.
Germany will donate €100 million ($121.83 million) to the global vaccine sharing program COVAX, along with 30 million surplus doses for poorer nations, German Chancellor Angela Merkel said during a G20 summit, adding that other countries should do the same.
UPDATED: Friday, May 21 at 9:25 a.m.
Johnson & Johnson signed a supply agreement with GAVI for 200 million doses, which will be used for the global vaccine-sharing program COVAX. Gavi said the goal will be to ship the doses to countries beginning in 2021 while it negotiates an additional 300 million J&J shots for 2022.
Japan issued emergency authorizations for COVID-19 vaccines from Moderna and AstraZeneca for people aged 18 and older. The approvals come as Japan faces another wave of infections just months before the Summer Olympics in Tokyo. The country previously agreed to buy 120 million doses of AZ’s two-shot vaccine and 50 million of Moderna’s shot, although the mRNA biotech said it's in discussions to supply an additional 50 million.
Pfizer and BioNTech pledged to provide poorer nations with up to 2 billion doses of their vaccine through 2022, a move that could help patch the unequal global vaccine rollout, Reuters reports. Pfizer chief Albert Bourla said low-income countries would be offered the vaccine at cost while middle-income countries would pay roughly half the price of wealthy countries. The companies have yet to decide whether the vaccine sharing facility COVAX would handle the agreements.
The European Union’s drug regulator is conducting a rolling review of the COVID-19 therapy from GlaxoSmithKline and Vir Biotechnology, dubbed sotrovimab, following a positive ruling from a key committee. The antibody treatment is intended for patients aged 12 and older who don’t require supplemental oxygen but are at risk of severe disease.
Two doses of AstraZeneca’s vaccine could be between 85% to 90% effective at preventing symptomatic disease, according to early estimates from Public Health England, although the agency warned the data is preliminary. The readout of the shot’s performance was the first in a real-world setting. Britain was the first country to authorize and deploy AZ’s jab.
UPDATED: Thursday, May 20 at 3:15 p.m.
A Japanese health panel has endorsed the vaccines from AstraZeneca and Moderna for people aged 18 and older, and the ministry is expected to give the official nod on Friday. This will bring Japan’s total number of approved COVID-19 vaccines to three, including the shot from Pfizer and BioNTech.
India’s Bharat Biotech said on Thursday that it will produce an additional 200 million doses of its COVID-19 vaccine annually. The vaccine, known as Covaxin, will be made at the company’s plant in Gujarat. Doses from the site will be made available beginning in the fourth quarter this year.
BioNTech CEO Ugur Sahin is confident the company’s vaccine, which it developed alongside Pfizer, will work against the troublesome variant found in India, known as B.1.617.2. The biotech chief said in televised comments that he anticipates the shot will be roughly 70 to 75% effective at protecting against infections with the variant, which is now circulating in the U.K.
UPDATED: Thursday, May 20 at 9:15 a.m.
Emergent BioSolutions’ top executive revealed that more than 100 million Johnson & Johnson vaccines are on hold as federal regulators check them for potential contamination. The company, which has yet to receive approval to ship the drug substance it manufactures, also acknowledged the unsanitary conditions at its Bayview Baltimore plant, which J&J now operates.
Pfizer has reached a supply deal with the European Union for 900 million doses of its BioNTech-partnered mRNA vaccine, with the option to secure an additional 900 million. The latest supply deal is in addition to the 600 million the EU has already ordered. Deliveries will begin in December and run into 2023. Story
CSL does not have the capacity to produce both the Novavax and AstraZeneca shots in Australia, Reuters reports. The company is under contract to make 50 million AZ doses locally, but Australia has relied on shipments of Pfizer’s shot after limiting AZ’s rollout due to blood clot concerns. While Novavax is awaiting regulatory approval in Europe, the U.S. and Britain, the company is also searching for an Australian manufacturing partner to help fulfill its supply deal with the country.
The Swiss government said it has recruited 75 workers to staff a Lonza plant in Visp to help manufacture doses of Moderna’s mRNA vaccine. The CDMO reportedly reached out to the government in April seeking 100 additional staff members when it ran into a shortage of qualified workers.
The head of the World Trade Organization Ngozi Okonjo-Iweala said it was clear that waiving IP rights for COVID-19 vaccines wouldn’t be enough to get doses to the world’s poorest nations. Poorer nations that constitute half of the globe's population have received only 17% of available doses so far, the World Health Organization says.
UPDATED: Wednesday, May 19 at 3:30 p.m.
Emergent BioSolutions has been playing defense ever since it ruined millions of doses of Johnson & Johnson's COVID-19 vaccine. Ahead of a congressional hearing Wednesday, the company said its efforts to produce that shot in addition to AstraZeneca's vaccine led to the mishap, The Wall Street Journal reports.
Eli Lilly has inked the latest in a series of deals to boost supplies of pandemic drug baricitinib in India. BDR Pharma has signed up to produce and distribute the drug, which is authorized in India in combination with Gilead's remdesivir in hospitalized patients.
India's Gland Pharma has purchased manufacturing assets from Vitane Biologics for $12.3 million to help with local production of the Russian COVID-19 vaccine Sputnik V. The company earlier this year agreed to make up to 252 million doses of the shot.
UPDATED: Wednesday, May 19 at 9:15 a.m.
Top executives from Emergent BioSolutions—the troubled CDMO responsible for millions of ruined Johnson & Johnson vaccine doses—are set to appear before House lawmakers, including some they’ve made political contributions to, The New York Times reports. Federal campaign records show Emergent’s founder, Fuad El-Hibri, donated at least $150,000 to groups associated with Rep. Steve Scalise (R-L.A.). Two other subcommittee members received funds from the company’s political action committee.
India’s Biological E. will manufacture doses of Johnson & Johnson’s vaccine alongside its own jab, a company executive told Reuters. The company previously told the news agency that it had hoped to manufacture 600 million J&J doses annually. Biological E. is also aiming to produce up to 80 million doses of its own vaccine by the fall, which it developed with Baylor College of Medicine in Houston and Dynavax Technologies Corp.
A forthcoming study found that the vaccine from AstraZeneca and Oxford University can work as a third booster shot, the Financial Times reports, citing people familiar with the matter. The study from Oxford reportedly found that the third dose boosts people’s antibodies against the virus’ despite concerns that the body might fend off the adenovirus, or an inactivated virus.
Pfizer said it will start manufacturing components of its mRNA vaccine at an existing company facility in Ireland and expects its first outputs by the end of the year. Irish Prime Minister Micheál Martin said in a tweet that the $40 million investment would create 75 new jobs at the facility in Dublin.
UPDATED: Tuesday, May 18 at 3:45 p.m.
India likely won’t resume sizable exports of COVID-19 shots it manufactures until October, a move that will worsen already delayed shipments to the global vaccine sharing facility COVAX, three government sources told Reuters. India banned exports of the vaccine last month in order to use that supply for domestic needs. The Serum Institute of India, the globe’s largest vaccine manufacturer, told the news agency that it hopes to resume shipment of AstraZeneca’s shot to COVAX by year’s end, but added that it has “never exported vaccines at the cost of the people of India.”
The U.S. administered roughly 600,000 Pfizer vaccines in adolescents aged 12 to 15 last week after the FDA authorized the shot for that age group, CDC Director Dr. Rochelle Walensky said. That brings the total number of people vaccinated under 17 in the U.S. to more than 4 million.
Medicago and GlaxoSmithKline have presented interim phase 2 data on their plant-derived adjuvanted COVID-19 vaccine candidate, CoVLP+AS03, that suggests its differentiated from other jabs through the mixed cellular response it triggers. Neutralizing antibody levels rose somewhat in the 21 days after the first dose, and jumped over the 21 days after the second shot. Medicago said the antibody levels were 10 times higher than those seen in patients recovering from COVID-19. Story
UPDATED: Tuesday, May 18 at 9:55 a.m.
Johnson & Johnson cut its vaccine deliveries to the European Union by half this week, and it’s unclear how many doses the company will send next week, an EU official told Reuters. J&J committed to sending the EU 55 million doses during the second quarter this year, but so far it’s only sent 5 million. The drugmaker told Reuters it still expects to hit 200 million doses shipped to the bloc in 2021 “as manufacturing sites fully activate throughout the year.”
Leaders representing the world’s largest economies blew off the idea of a patent waiver for COVID-19 vaccines in a draft report from a G20 summit, favoring voluntary licensing instead as a means of expanding access to the shots in the world’s poorest nations, Reuters reports. The draft is the result of a compromise among experts from the G20 nations and could still be subject to changes, according to the report.
Preliminary results from a study out of Spain, known as Combivacs, found that giving people a dose of Pfizer’s vaccine after a first dose using AstraZeneca’s shot is highly safe and effective. The study, which enrolled 670 volunteers, found that the presence of neutralizing antibodies increased sevenfold after a second dose using Pfizer’s vaccine, which was far higher than those produced after a second shot using AZ’s vaccine. Fewer than 2% of participants reported severe side effects, which included headaches, muscle pain and general discomfort.
Roche announced its Cobas coronavirus test has received an FDA emergency nod for people without symptoms or reason to suspect COVID-19 infection. The agency’s authorization of the real-time RT-PCR test comes after the CDC updated its testing guidance to include people who don’t show symptoms, the company said.
UPDATED: Monday, May 17 at 3:10 p.m.
The Biden administration plans to send at least 20 million FDA-authorized vaccine doses to other countries by the end of June, marking the first time the U.S. will share its domestically-used shots abroad. The latest contribution will bring the country’s total number of doses donated to 80 million following its contribution of 60 million AstraZeneca doses earlier this month, although that vaccine hasn't received the FDA's nod.
Researchers at the University of California and the Gladstone Institute of Virology in San Francisco have found that both mRNA vaccines from Moderna and Pfizer-BioNTech induce strong T cell responses against two important coronavirus variants, B.1.1.7 first found in the U.K. and B.1.351 found in South Africa. In a pre-print version of the report, which has yet to undergo peer review, researchers said they'd found a "reassuringly unaltered T cell response against the variants." Story
Humanigen has entered into a manufacturing services agreement with CDMO Chime Biologics to produce bulk drug substance and drug product for its monoclonal antibody lenzilumab, which is currently under development for the treatment of hospitalized COVID-19 patients. Chime’s manufacturing will supply regions outside of the U.S., including Europe, the U.K., India and Brazil, pending regulatory approval, Humanigen said.
UPDATED: Monday, May 17 at 9:05 a.m.
Sanofi and GlaxoSmithKline have passed a small phase 2 COVID-19 vaccine trial and are now plotting a much larger phase 3 study. While the latest data has yet to be published in a peer-reviewed journal, the pair said their recombinant shot “achieved strong rates of neutralizing antibody responses,” which was “in line” with those measured in people who have recovered from COVID-19. Story
The head of UNICEF, Henrietta Fore, asked G7 countries to make an emergency donation to the global vaccine sharing program COVAX, which is facing a shortage of supplies due to export restrictions in India. The program is facing a supply shortfall of 140 million doses by the end of May and about 190 million by the end of June after India curbed exports of AstraZeneca’s vaccine to use those shots to help fight back its latest wave of infections, Reuters reports.
The European Medicines Agency has recommended a change to the storage conditions for Pfizer’s vaccine from just five days at normal refrigerator temperature to up to one month, or 31 days. The move, based on additional stability study data, is “expected to have a significant impact on planning and logistics” for the shot’s European rollout, the EMA said.
Indonesia has stopped distributing a batch of Johnson & Johnson’s one-shot vaccine to run tests for sterility and toxicity after the death of a 22-year-old man, Reuters reports. The batch totaled 448,480 doses, which arrived as part of a 3.85 million-dose shipment from the vaccine sharing facility, COVAX.
Natco Pharma signed a non-exclusive, voluntary licensing agreement with Eli Lilly to manufacture and sell its COVID-19 drug baricitinib in India, the company said in a statement. Lilly’s baricitinib has been authorized to treat hospitalized COVID-19 patients in India when paired with remdesivir. The news comes a week after Lilly said it had inked similar agreements with three other Indian generic drugmakers to ramp up the drug’s supply in the country.
UPDATED: Friday, May 14 at 3:20 p.m.
The U.K. said it will accelerate its vaccine rollout to prevent a worrisome coronavirus variant first identified in India, known as B.1.617.2, from wreaking havoc on its reopening plans. Prime Minister Boris Johnson said the government would speed up second doses to older residents and the medically vulnerable to just eight weeks after the first dose, Reuters reports. The U.K. has so far given a first dose to nearly 70% of its adult population.
The World Health Organization urged rich countries to donate their COVID-19 vaccine to the global sharing facility COVAX, rather than immediately vaccinate their children. The move would allow for other priority populations in low- to-middle income countries to receive doses sooner, the agency argued. The U.S. and Canada recently authorized the use of Pfizer's vaccine for those aged 12 to 15.
Humanigen is prepping its COVID-19 drug lenzilumab for an emergency use authorization with the FDA before the month’s end. The company said it had “recently held a meeting with FDA” to discuss the filing of an EUA for lenzilumab, specifically for hospitalized, hypoxic COVID-19 patients, “at the end of May.” Story
UPDATED: Friday, May 14 at 9:45 a.m.
A longer 12-week wait between someone’s first and second shot with Pfizer's COVID-19 vaccine produces a greater antibody response in elderly people, according to new findings from researchers at the University of Birmingham. The study found that neutralizing antibodies in those with the longer gap were 3.5 times higher on average than those with the recommended three-week period following a second shot. Researchers say the findings support the U.K.’s controversial decision to extend the wait between shots in an effort to administer more first doses.
The Biden administration won’t send any doses of Johnson & Johnson’s one-shot vaccine to states next week following the drugmaker’s troubles with an Emergent manufacturing plant in Baltimore, The Washington Post reports. A White House health official told states leaders on a weekly call last week that more doses will become available once federal regulators clear the Emergent facility.
Russian manufacturers tasked with producing shots of the country’s Sputnik V vaccine are struggling to secure equipment and find qualified staff to ramp up the shot’s production, Reuters reports, citing six sources. So far, Russia has produced 33 million doses and has exported less than half of them. The Russian Direct Investment Fund (RDIF) told Reuters it has shown a “strong commitment” to honoring its supply contracts.
Dr. Reddy’s Laboratories started rolling out its first shipment of Russia’s Sputnik V vaccine, which gained regulatory approval after arriving on May 1. The company has priced the shot at ₹995 ($13.59) per dose, according to a statement, although that price could drop once the shots are made by Indian manufacturers. Dr. Reddy’s has an agreement with the Russian Direct Investment Fund (RDIF) to market 250 million doses of the vaccine, Mint reports.
UPDATED: Thursday, May 13 at 3:25 p.m.
The CDC said in newly issued guidance that Americans who are fully vaccinated can safely stop wearing masks and social distancing in most indoor and outdoor settings. There are some exceptions: People should still wear masks inside crowded areas like buses, planes, hospitals, prisons and homeless shelters, the agency says. U.S. daily infections have been on a steady decline, reaching their lowest level since last September, the AP reports. The CDC considers someone fully vaccinated two weeks following their second shot, or two weeks after a one-dose vaccination.
China said it supports the controversial intellectual property waiver for COVID-19 vaccines set forth before the World Trade Organization, Reuters reports, citing a Commerce Ministry spokesman. China will “work with all parties to actively participate in consultations and jointly promote a balanced and effective solution,” the spokesman said.
Federal health officials have paused shipments of Eli Lilly’s combo bamlanivimab-etesevimab COVID-19 cocktail to Illinois because of concerns about a variant first found in Brazil, known as P.1, circulating there. In vitro studies have indicated that Lilly's combo medicine is "not active against the P.1 variant," federal agencies said in a joint notice. Story
United Airlines and Abbott have teamed up to offer international travelers a much more streamlined approach to obtaining the negative COVID-19 test required to enter the U.S. Now that the country will accept any at-home antigen or nucleic acid amplification test with an FDA emergency nod, United travelers on round-trip international flights that depart from and return to the U.S. can directly order a six-pack of BinaxNOW Home Tests through the airline’s website. Story
UPDATED: Thursday, May 13 at 9:05 a.m.
Eli Lilly has already inked a series of licensing deals to boost availability of its COVID-19 drug baricitinib in India. Now, the Indianapolis drugmaker has brought on MSN Labs and Torrent to help boost production. Baricitinib, approved in many countries as arthritis drug Olumiant, recently scored emergency approval in India in combination with Gilead's remdesivir for hospitalized patients requiring oxygen therapy or mechanical ventilation.
Receiving a second COVID-19 vaccine dose different from the first dose is safe, although it could lead to more mild side effects, such as headache, chills or a fever, according to results from a controversial U.K. study published in the Lancet. The study, which enrolled more than 800 people, studied people who were given a Pfizer shot followed by an AstraZeneca dose, and vice versa. Data on effectiveness is expected next month, CTV reports.
Roche CEO Severin Schwan is the latest high-profile pharmaceutical executive to criticize the COVID-19 vaccine waiver proposal at the World Trade Organization. In an interview with The Financial Times, he compared the potential move to East Germany's nationalization of pharmaceutical companies. Story
India’s most populous state, Uttar Pradesh, will spend up to $1 billion for COVID-19 vaccines and has already held discussions with Pfizer and a local distributor of Russia’s Sputnik V shot, Reuters reports, citing a state official. The move comes as India struggles to battle back a record surge in coronavirus infections.
Australia signed a deal to purchase 25 million doses of Moderna's vaccine. Meanwhile, the country is in talks with the biotech about local production, Reuters reports. Australia has recommended people under 50 don't receive AstraZeneca's shot, which has delayed its overall vaccination push.
UPDATED: Wednesday, May 12 at 3:45 p.m.
The CDC’s Advisory Committee on Immunization Practices (ACIP) endorsed the use of the COVID-19 vaccine from Pfizer and BioNTech in adolescents aged 12 to 15. The ACIP’s recommendation paves the way for teens to get vaccinated as early as Thursday once given the sign off from CDC Director Dr. Rochelle Walensky.
Emergent’s top leadership is set to appear before Congress as part of lawmakers’ investigation into the CDMO’s manufacturing contracts and production errors, which resulted in millions of ruined Johnson & Johnson COVID-19 vaccines. Emergent founder and executive chairman Fuad El-Hibri and CEO Robert Kramer will testify before the House Select Subcommittee on the Coronavirus on May 19. Story
The CDC has confirmed 28 cases of a severe type of blood clot cropping up among some people vaccinated with Johnson & Johnson’s COVID-19 vaccine, known as thrombosis with thrombocytopenia syndrome, according to slides presented during a meeting with a panel of vaccine advisers. However, the cases still remain rare out of the more than 8.7 million people who’ve been vaccinated with J&J’s shot so far, according to the agency's count.
Preliminary studies awaiting peer review show that the vaccines from Pfizer and Moderna have shown decreased effectiveness against a SARS-CoV-2 variant circulating in India, known as B.1.617, according to the World Health Organization. The global health agency warned, however, that real-world studies still need to be conducted. Meanwhile, Bharat Biotech’s Covaxin remained largely effective against the variant, according to one preliminary study the WHO cited.
The CDC is set to drop its recommendation that people not get a COVID-19 vaccine two weeks before or after being vaccinated with another medicine, according to slides presented at its Advisory Committee on Immunization Practices (ACIP) meeting. A handful of drugmakers reported the rule, as well as the accelerated vaccine rollout, as part of the reason why sales for other vaccines slumped during the first quarter.
UPDATED: Wednesday, May 12 at 9:00 a.m.
A key panel of CDC advisors will meet on Wednesday to discuss the use of the vaccine from Pfizer and BioNTech in adolescents aged 12 to 15. Following the Advisory Committee on Immunization Practices (ACIP)’s recommendation, people in that age group could get vaccinated as early as Thursday, officials have said. CDC Director Dr. Rochelle Walensky told CNBC during a health summit on Tuesday that, with the shot's help, she thinks the U.S. should be in “full in-person school in the fall.”
The U.K. government has rethought plans to buy one million doses of AstraZeneca's anti-SARS-CoV-2 antibody currently under development, according to anonymous sources quoted by Bloomberg. A supply agreement between the U.K. and AZ for was first reached in November, but officials have since seen (PDF) data that “indicates lower protection in vaccinated adults who are immunosuppressed,” leading it to prioritize the vaccination of the household contacts of people with severe immunosuppression. Story
Norway will reportedly not resume the use of AstraZeneca’s COVID-19 vaccine, and a decision regarding Johnson & Johnson’s vaccine is also forthcoming, Reuters reports, citing the newspaper VG. Authorities suspended the AstraZeneca vaccine's rollout in March following reports of rare side effects, including blood clots.
Moderna has signed a supply deal with Australia for 25 million doses of its two-shot mRNA vaccine, the company announced. The agreement includes 10 million doses of the vaccine targeting the original strain, expected to be delivered in 2021, plus 15 million doses of the company’s forthcoming booster, which will be supplied in 2022, Moderna says.
The mRNA technology used in the vaccine from Pfizer and BioNTech could lead to “more potent” seasonal flu shots, Kathrin Jansen, the head of Pfizer’s vaccine research and development, told CNBC. As it currently stands, scientists have to monitor rapidly evolving flu strains and select which one will be in a vaccine. However, with mRNA technology, they can now quickly “pivot” their shot to target more dominant strains, Jansen said.
Shortly following its U.S. FDA go ahead, Pfizer is now seeking the U.K.’s approval for its vaccine in adolescents aged 12 to 15, Reuters reports, citing a company representative. The shot is already authorized in Canada and in the U.S., where it’s undergoing the CDC’s review.
Samsung Biologics and Pfizer have denied a report that the pair were working together in South Korea to produce Pfizer’s COVID-19 vaccine. The earlier report from the Korea Economic Daily said the biotech side of Samsung had been revamping production lines at one of its facilities to make room for Pfizer’s vaccine.
UPDATED: Tuesday, May 11 at 3:48 p.m.
With 62% of its population vaccinated, the highest rate of any country in the world, Seychelles believed that it was well on its way to licking its coronavirus problem. But last week, active cases more than doubled, raising concerns that vaccinations aren’t effective. The island nation in the Indian Ocean reported 2,486 new cases last week, with 37% of those coming in people who had received two shots. The country used vaccines made in China, by Sinopharm, and India, under a license from AstraZeneca. A similar situation exists in another Indian Ocean island country, the Maldives, where the same two vaccines have been distributed.
Novavax will not seek approval for its COVID-19 vaccine until July because it needs to demonstrate to regulators that its manufacturing processes are consistent across different sites. CEO Stanley Erck revealed the setback in an earnings call with investors on Monday, confirming a report in the morning by the Washington Post. Erck also said that the company has 30-40 million vaccine doses in storage and plans to produce 150 million doses per month by the fourth quarter. Story
Aenova Group is expanding capacity at its manufacturing site in Latina, Italy, for the production of COVID-19 vaccines. A new high-speed line will provide a capacity of 80 million vials and more than 180 million prefilled syringes per year. It is the first of a planned expansion that will include up to four such lines. The CDMO employs 600 at the site, one of the largest in Aenova’s network.
With the coronavirus pandemic subsiding in the U.S., Eli Lilly announced its plan to reopen offices. At headquarters in Indianapolis, Lilly will welcome back 25% of its workforce starting on June 1, with vaccinations, masking and distancing required. By July 12, the company will open offices to all of its employees. Lilly is urging employees to get vaccinated but is not requiring it. CEO David Ricks, who made the announcement in a streetside media event and in a letter posted on Linkedin, also said some accommodation will be made for those who wanted to work remotely. Story
The pharma industry received a generous reputation boost with its quick response to the coronavirus pandemic, providing a vaccine in record time. But the curve has flattened out according to a Harris Poll survey. Sixty percent of Americans now rate the industry positively as opposed to 62% in February. One of the reasons for the pharma stall is the pauses of the Johnson & Johnson and AstraZeneca COVID-19 vaccines over safety concerns. Story
Despite several months of controversy for AstraZeneca, shareholders have approved a lucrative pay package for CEO Pascal Soriot, bumping up the ceilings on his equity incentive awards and bonus. Despite calls from investor advisory groups to reject increased compensation for Soriot, more than 60% of shareholders voted to increase his awards limit from 550% of his salary to 650%, while his bonus limit goes from 200% of his salary to 250%. Story
Pfizer and Regeneron are among the companies who plan to continue supplying COVID-19 vaccines and treatments into the distant future. Pfizer CEO Albert Bourla said that he is in discussion with countries to supply COVID-19 vaccines through 2024. Regeneron CEO Len Schleifer recently said that, along with partner Roche, they plan to supply 2 million doses of their antibody cocktail per year. Pfizer is poised to provide 3 billion vaccine doses this year and another 3 billion in 2022. Story
UPDATED: Tuesday, May 11 at 9:15 a.m.
For the first time in the U.S., the FDA has issued emergency authorization for the use of the COVID-19 from Pfizer and BioNTech in adolescents aged 12 to 15. The FDA will amend the existing emergency authorization for the vaccine, which was first issued in December, the agency said. The vaccine's two-dose regimen will be the same for adolescents as it is for adults. Story
The U.S. could start vaccinating adolescent Americans as early as Thursday after a key advisory committee from the CDC considers the expansion on Wednesday, said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. President Joe Biden said in a statement following the FDA’s emergency nod that the vaccine’s expanded use is "a promising development in our fight against the virus.”
The European Union launched a new lawsuit against AstraZeneca for breaching its COVID-19 vaccine contract, although this time it could result in financial penalties for the company, Reuters reports. Brussels is demanding AstraZeneca supply the EU with a total of 120 million doses of its vaccine by the end of June, still lower than the 300 million it had expected to deliver by that point. AZ’s lawyers said the latest lawsuit was not needed given the EU had already launched one in April.
Takeda Pharmaceutical is considering doubling its imports of Moderna’s two-dose mRNA vaccine to help Japan speed up its vaccination efforts, CEO Christophe Weber said. The drugmaker, charged with handling Japan’s vaccine imports, is working with the government to boost shipments to 100 million. Story
The CDC earlier this month shifted how it monitors vaccinated people who’ve been infected with COVID-19, which has drawn criticism from some scientists, Bloomberg reports. The CDC now tracks those who are infected and vaccinated only if they’re hospitalized or die in an effort to collect more quality data, the agency told Bloomberg. The CDC also added that there have been few worrying patterns so far, and the agency plans to conduct studies to evaluate infections among vaccinated people.
Bayer plans to repurpose one of its existing nitrogen plants at a facility in Vapi, India, into a permanent source of oxygen supply to a local hospital, The Economic Times reports. The company will also provide oxygen concentrators to primary health centers (PHCs) in rural Indian communities, which have been hit with a recent surge of COVID-19 infections.
UPDATED: Monday, May 10 at 3:35 p.m.
The FDA's independent vaccine panel is set to hold a meeting on June 10 to discuss the use of the COVID-19 vaccines in children. The committee will not discuss any particular vaccine, but rather will inform the public about the FDA’s “expectations for the data and information needed to support requests" for emergency authorizations, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
BioNTech’s COVID-19 vaccine brought in revenues of €2.03 billion ($2.47 billion) in the first quarter, with the majority coming from profit sharing with BioNTech’s U.S. partner Pfizer, the company said. With that cash now in hand, BioNTech plans to invest into further maturing the company with hopes to “deliver multiple product launches over the next five years,” CEO Ugur Sahin told analysts on a call. Story
AstraZeneca has delivered 50 million doses of its COVID-19 vaccine to the European Union, reaching a milestone that was originally scheduled for January, Reuters reports. The achievement comes as the EU moves to sue AstraZeneca for a second time following the original legal action it kicked off in late April, according to the report. The second lawsuit could allow the bloc to seek potential financial penalties.
BioNTech, after making inroads with its COVID-19 vaccine in Western countries under a partnership with Pfizer, is preparing to launch the shot in China with the help of Fosun Pharma, Fosun said in a filing (PDF) to the Hong Kong Exchange. The venture—a 50-50 split to make and sell the mRNA shot in China—comes as the pair expects a Chinese approval for the vaccine, known as BNT162b2 or Comirnaty, by July the latest, executives have said. Story
The World Health Organization listed a coronavirus variant spreading rapidly in India as a “variant of concern,” joining the three other troublesome mutated strains first identified in South Africa, Brazil and the U.K. The variant, dubbed B.1.617, is thought to be more transmissible than the original strains and will require additional tracking and analysis, the global health agency said.
UPDATED: Monday, May 10 at 9:00 a.m.
AstraZeneca could potentially pass over its FDA application for emergency use for its COVID-19 vaccine and seek a full approval instead, The Wall Street Journal reports, citing people familiar with the matter. The move, which would take more time than an emergency nod, could further delay the shot’s rollout in the U.S. by months. The company has previously said it still intends to apply for emergency approval, although the Journal previously reported that AZ has run into trouble gathering data for its application from the millions of people already vaccinated in the U.K.
The European Union signed a contract with Pfizer and partner BioNTech for 1.8 billion doses of the companies’ two-dose vaccine, European Commission head Ursula von der Leyen said in a tweet. The deal, set for 2021 to 2023, is designed to cover booster shots, donations and the reselling of doses, Reuters reports.
The European Union has not placed additional orders for AstraZeneca’s COVID-19 vaccine beyond its current deal, which is set to end in June, European Internal Market Commissioner Thierry Breton said. However, Breton added that the company has “a very good vaccine” and that the bloc “will have other orders.” The EU launched legal action against AZ last month for not respecting its supply contract.
Eli Lilly said it signed licensing deals with three Indian generic drugmakers to expand the availability of its baricitinib, authorized to treat hospitalized COVID-19 patients when paired with remdesivir. The three drugmakers, Cipla, Lupin and Sun Pharma, will help Lilly manufacture and sell baricitinib, the company’s arthritis drug, in India. Story
The GAVI Vaccine Alliance is in talks with China’s Sinopharm, which earned the World Health Organization's emergency backing late last week, and other vaccine makers for additional doses for the vaccine-sharing facility COVAX, a spokesperson told Reuters. So far, COVAX has been hampered by supply setbacks stemming from the Serum Institute of India after Indian authorities restricted exports.
UPDATED: Friday, May 7 at 2:50 p.m.
The World Health Organization issued emergency authorization for a COVID-19 vaccine from China’s state-owned drugmaker Sinopharm, a move that would allow the shot to be included in the vaccine sharing facility COVAX. Sinopharm’s two-dose vaccine is the first shot developed by a non-Western nation to win the WHO’s backing, Reuters reports.
The European Commission is nearing a supply deal with Pfizer for 1.8 billion doses of its two-shot vaccine for 2022 and 2023, Bloomberg reports, citing two people familiar with the matter. The EU closed its negotiations with the company last week and told ambassadors that the deal was ready for signatures on Wednesday. An announcement could come as early as Friday, according to the report.
Senior CDC official Nancy Messonnier, who was among the first high ranking health experts to warn Americans of the grave danger the coronavirus pandemic posed, is resigning from her position with the agency, The Washington Post reports, citing an internal agency email. Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases since 2016, was sidelined at the beginning of the pandemic after her comments angered former President Donald Trump. Messonnier will become executive director for pandemic and public health systems at the Skoll Foundation.
A European Medicines Agency's safety committee said it’s evaluating an assortment of potential side effects following inoculation with leading COVID-19 vaccines. Those concerns include cases of heart inflammation and facial swelling among Pfizer vaccine recipients, as well as reports of a rare nerve-degenerating disorder, known as Guillain-Barre syndrome, among people inoculated with AstraZeneca’s shot. Story
UPDATED: Friday, May 7 at 8:50 a.m.
Pfizer and BioNTech have initiated an FDA application to the FDA for full approval of their COVID-19 vaccine in people 16 and older. The companies said they will submit the required manufacturing and facility data for licensure to complete their application in the coming weeks. Since earning an emergency authorization in December, the companies said they’ve delivered 170 million doses of their two-shot vaccine.
Pfizer CEO Albert Bourla said he is “not at all” in favor of the Biden administration’s decision to endorse a controversial measure that would waive patent protections for COVID-19 vaccines, AFP reports. In an interview, Bourla said the problem is that there are “no facilities in the world outside the ones that we can build ourselves, that can make mRNA vaccines.” The Pfizer chief cautioned against disrupting current operations “with politically motivated announcements,” calling them empty promises.
The European Medicines Agency has started a rolling review of GlaxoSmithKline’s monoclonal antibody for the treatment of COVID-positive adults and adolescents, GSK said. The therapy, dubbed sotrovimab or VIR-7831, is intended for patients who don’t require supplemental oxygen but are at risk of severe disease.
Britain will offer people under the age of 40 an alternative to AstraZeneca’s COVID-19 vaccine following concerns of rare but serious blood clots, The Daily Telegraph and The Independent newspapers report. The Joint Committee on Vaccination and Immunisation (JCVI), an independent group of experts that advises the U.K. on vaccinations, suggested people in that age group be offered shots from Pfizer and Moderna out of "an abundance of caution.”
Japan could authorize the vaccines from AstraZeneca and Moderna as early as May 20, financial newspaper Nikkei reports. So far, Japan has only authorized the vaccine from Pfizer and BioNTech.
UPDATED: Thursday, May 6 at 2:40 p.m.
Moderna said a phase 2/3 trial studying its vaccine in adolescents aged 12 to 17 found the vaccine to be 96% effective with no serious safety concerns. The biotech is in discussions with federal regulators to amend its existing authorization to include that age group. Meanwhile, the company said it will begin the process for full FDA approval in adults this month. Story
Germany rejected the Biden administration’s decision to back a controversial intellectual property waiver for COVID-19 vaccines, saying the problem is with manufacturing and quality standards rather than patents. A government spokesperson told Reuters that IP protection is a “source of innovation and must remain so in the future.”
Moderna CEO Stéphane Bancel said he didn’t lose any sleep over the Biden administration’s decision to back the IP waiver proposal before the World Trade Organization. Even if the measure passed, drugmakers interested in manufacturing mRNA vaccines would need to conduct the clinical trials, apply for authorization and then scale up manufacturing, which could take upwards of 12 to 18 months, Bancel argued. Story
Novavax, nearing a possible emergency use filing for its COVID-19 vaccine, dropped more data on how its shot works against a particular variant. When pinned against the variant found in South Africa, better known as B.1.351, the vaccine’s efficacy hit 51% in HIV-negative subjects of a midstage trial. Meanwhile, efficacy dropped slightly in HIV-positive patients, to 43%, though given the nature of the disease and its impact on the immune system, this was not unexpected. Story
UPDATED: Thursday, May 6 at 8:35 a.m.
Pfizer and BioNTech will donate doses of their mRNA vaccine for athletes set to participate in the Tokyo Olympic Games in July and August. Doses will ship out later this month so athletes can be fully vaccinated before the games begin.
Moderna reported $1.73 billion in sales for its COVID-19 vaccine. The shot is one of the leading vaccines worldwide, but the sales figure is about half of what Pfizer reported earlier this week. That mRNA shot pulled down $3.5 billion during the first quarter. Story
On the therapeutic front, Regeneron said its antibody cocktail Regen-Cov generated $262 million during the first three months of the year. That figure trailed Regeneron's big-selling eye drug Eylea, which generated $1.347 billion, but it came in ahead of Regeneron's other medicines.
Novavax finalized its advance purchase deal with Gavi, the Vaccine Alliance to manufacture and deploy 350 million doses of its vaccine to COVAX-participating countries and economies. Aided by manufacturing partner Serum Institute of India, Novavax aims to start deliveries of a cumulative 1.1 billion doses of its shot to COVAX in the third quarter, assuming the vaccine passes muster with regulators.
With about 24,000 employees worldwide, Amgen is allowing many to continue working remotely for the foreseeable future. About 2,000 employees are still working on a daily basis at the company's California headquarters.
UPDATED: Wednesday, May 5 at 3:15 p.m.
Pfizer’s COVID-19 vaccine, produced alongside Germany’s BioNTech, has been authorized for use in adolescents aged 12 to 15 in Canada, the companies announced. The shot is the first to be authorized in the country for children in that age group. The drugmakers are also seeking to expand the use of their shot to adolescents in Europe and the U.S., where an FDA decision could come by early next week.
The Biden administration will support lifting intellectual property protections for COVID-19 vaccines, a move intended to ramp up global access, U.S. Trade Representative Katherine Tai said in a statement. The U.S., which has been an opponent of a measure presented to the World Trade Organization that would temporarily suspend IP rights, will now "actively participate" in the WTO discussion to pass the measure, Tai said.
Germany’s CureVac is on track to file its COVID-19 vaccine for authorization in Europe as early as this month as cases among its late-stage clinical trial participants quickly accrue, Chief Executive Franz-Werner Haas told Reuters.
Similar to warnings issued for Chinese state-owned drugmaker Sinopharm, a group of World Health Organization vaccine experts are now warning that some data from China’s Sinovac are also lacking. The WHO’s Strategic Advisory Group of Experts (SAGE) said in a report that while Sinovac’s shot appears effective, they have a “low level of confidence” over the risk of serious side effects in people above 60, as well as other groups at high risk from COVID-19.
A U.N. spokesperson told Reuters that Secretary-General Antonio Guterres believes vaccine developers should allow other companies to manufacture their shots. Guterres’ comments come as the World Trade Organization weighs a proposal set forth by South Africa and India to waive patent rights on COVID-19 vaccines to ensure greater access. However, some U.N. officials have called the discussions a “distraction” that won’t solve the world's manufacturing problems.
UPDATED: Wednesday, May 5 at 9:40 a.m.
Eli Lilly employees accused an executive at one of the company's factories of modifying documents required by federal regulators in an effort to downplay serious quality control problems at the facility, which produces Lilly’s COVID-19 antibody drug bamlanivimab, Reuters reports, citing an internal complaint document and a source familiar with the matter. The complaint argues that the executive rewrote findings from Lilly’s technical experts at its factory in Branchburg, New Jersey. Lilly confirmed the internal complaint with Reuters but said it couldn’t comment further since a third-party investigation was underway. Story
Indian regulators issued an emergency authorization for the COVID-19 antibody cocktail from drugmakers Roche and Regeneron, which is a combination of casirivimab with imdevimab. Roche last week said it would seek a fast-tracked authorization for the cocktail in India and said it could begin supplying the drug immediately once given the OK.
World Health Organization experts voiced “very low confidence” in some data provided by Chinese drugmaker Sinopharm over its vaccine and the risk of serious side effects among certain patients who received the shot. According to a report from the WHO’s Strategic Advisory Group of Experts (SAGE), the panel of vaccine experts said they’re confident in the shot’s ability to prevent COVID-19 in adults. However, they warned that the company didn’t have enough data examining the shot in people with comorbidities or “health states that increase risk for severe COVID-19" following vaccination.
Anthony Fauci, the government’s top infectious diseases expert, said he believes the U.S. will be able to pick up its lagging vaccination rate by moving away from its “mass vaccination approach” and targeting local pharmacies and walk-in locations instead, CNN reports. Fauci’s comments come a day after the Biden administration outlined a new strategy amid a slow down in vaccinations nationwide. The U.S. now aims to have at least 70% of the population fully or partially vaccinated by July 4.
UPDATED: Tuesday, May 4 at 3:40 p.m.
The Biden administration, faced with a slowing vaccine rollout in some parts of the country, announced a shift in its strategy that will move doses away from mass vaccination centers and toward more local settings to boost the number of shots in arms, The New York Times reports. The federal government is directing pharmacies to offer walk-in vaccine appointments, creating more pop-up sites and shifting doses to more rural areas in an effort to vaccinate 70% of Americans, at least partially, by July 4.
CureVac chief Franz-Werner Haas said U.S. export controls for key vaccine supplies are hurting the company’s ability to predict short-term supplies for its jab, which is still under development, Reuters reports. Speaking with weekly Der Spiegel, Haas said the problem was due to the Defense Production Act, which has prevented the company from securing all the materials it needs from the U.S. to create its own stockpile.
Moderna will more than double the size of its manufacturing facility in Norwood, Massachusetts, which will support a 50% increase in production for the company’s mRNA COVID-19 vaccine at the site. The latest expansion is part of the reasoning behind Moderna’s accelerated vaccine supply forecasts. The company now estimates it will produce between 800 million to 1 billion doses this year, and up to 3 billion doses in 2022. Story
UPDATED: Tuesday, May 4 at 9:15 a.m.
The FDA is expected to authorize Pfizer’s COVID-19 vaccine, which it created alongside BioNTech, for adolescents 12 to 15 years old by early next week, The New York Times reports, citing federal officials. The agency’s endorsement would be an amendment to Pfizer’s existing emergency use authorization, and the CDC’s Advisory Committee for Immunization Practices (ACIP) would likely meet the following day to examine the clinical trial data.
Eli Lilly will supply India with an initial 400,000 tablets of its COVID-19 therapeutic baricitinib to help the country battle its raging outbreak. Lilly received an emergency authorization from Indian authorities on Monday for baricitinib paired with Gilead’s remdesivir in hospitalized patients requiring supplemental oxygen. The drugmaker said it’s also working with local Indian pharmaceutical companies to “execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India.” Baricitinib is approved in many places as the rheumatoid arthritis drug Olumiant.
BioNTech chief Ugur Sahin said the company, alongside its partner Pfizer, will be able to produce nearly 3 billion doses of its COVID-19 vaccine in 2021 thanks to ramped-up manufacturing. The pair had previously announced a target of 2.5 billion doses in 2021. Sahin said the German biotech is fortunately “not facing too many technical problems,” allowing it to meet its estimated delivery schedules.
Gilead Sciences filed a lawsuit against the Russian government last month for allowing one of its companies, Pharmasyntez, to manufacture and market Gilead’s COVID-19 treatment remdesivir, STAT reports. Russia’s Pharmasyntez is reportedly exploring the idea of sending the medicine to India. A Gilead spokesperson told STAT that it was disappointed in Russia’s decision to grant a compulsory license for remdesivir, which is marketed as Veklury, and that it “falls short” of Russian legal requirements for issuing a license.
UPDATED: Monday, May 3 at 3:30 p.m.
The European Medicines Agency (EMA) started an "accelerated assessment" of Pfizer and BioNTech’s COVID-19 vaccine, known as Comirnaty, for people aged 12 to 15. The EMA said its recommendation could come in June—unless additional information is needed—and would apply to all member states, pending the European Commission’s final consent.
Canada’s National Advisory Committee on Immunization (NACI), which makes recommendations for the use of vaccines, advised residents to weigh the risk of rare but serious blood clots reported among some Johnson & Johnson vaccine recipients and, if considered necessary, wait for a different shot. J&J’s vaccine, which has now been recommended for people 30 and older in Canada, is expected to be distributed across the country soon, CBC reports. The country had held its first shipments of the vaccine on Friday to verify its safety and quality.
Novavax told the European Union that it plans to deliver its vaccine to the bloc by the end of this year, a sign that a forthcoming supply contract could be announced as early as this week, Reuters reports, citing an EU official. Under the deal, Novavax would supply up to 200 million doses, providing the EU with booster shots to help contain the coronavirus and potentially guard against new variants, the official said. Story
AstraZeneca said it still plans to submit its vaccine for emergency authorization in the U.S. "in the coming weeks," even though the nation has an ample supply of doses from companies like Pfizer, Moderna and Johnson & Johnson. CEO Pascal Soriot defended the drugmaker when grilled by reporters about its recent stumbles, pointing to AZ's rollout across Europe and in India, where 300 million people are set to be inoculated by this summer. Story
UPDATED: Monday, May 3 at 9:00 a.m.
Pfizer CEO Albert Bourla said the drugmaker is discussing an “expedited approval pathway” with the Indian government to authorize its vaccine in the nation, which is facing a raging outbreak driven by variants of the virus. In a statement, Bourla said Pfizer would also donate $70 million worth of medicines to India, including steroids to reduce inflammation, anticoagulants and antibiotics.
The World Health Organization listed Moderna’s COVID-19 vaccine for emergency use for people ages 18 and older, a designation that will allow other countries to expedite their own approval process for the shot. Moderna’s vaccine is the fifth to receive emergency validation from the organization.
Moderna signed a supply deal with the global vaccine-sharing facility COVAX for up to 500 million doses of its mRNA shot with the option to procure an additional 466 million doses in 2022. The biotech said it would deliver an initial 34 million doses to the facility, which is backed by the World Health Organization, in the fourth quarter this year. Separately, Sweden donated 1 million AstraZeneca doses to COVAX, saying it plans to receive future shipments of vaccines from other companies, Reuters reports.
India and South Africa plan to review their proposal that would temporarily limit IP rights for drugmakers’ COVID-19 vaccines, Law360 reports. The countries said they will meet with other World Trade Organization members that have opposed the IP waiver, including the U.S. and EU, in an effort to find common ground.
UPDATED: Friday, April 30 at 3:20 p.m.
Pfizer will begin shipping doses of its mRNA vaccine made in the U.S. to Canada starting next week, Reuters reports, citing a senior official. Canada will become the second country outside the U.S. to receive doses of the drugmaker’s vaccine from its plant in Kalamazoo, Michigan, following Mexico. The country said it expects 2 million doses per week in May.
Pfizer and BioNTech announced that they've asked the European Medicines Agency to expand the use of their COVID-19 vaccine to people between the ages of 12 and 15. Currently, the pair's vaccine is authorized in Europe for those aged 16 and older. The drugmakers said the request was based on early data from a phase 3 trial that showed the shot was 100% effective against COVID-19 among the more than 2,200 trial participants within that age group.
Some European Union member countries, including France and Germany, are still pushing the bloc to strike a supply deal with French drugmaker Valneva for its COVID-19 vaccine, sources familiar with the matter tell Reuters. The news comes just over a week after Valneva said it would no longer prioritize supply talks with the EU but rather try to sign deals on a country-by-country basis. Previous discussions were held in January for up to 60 million doses of the company’s inactivated vaccine candidate.
Gilead Sciences reported $1.5 billion in sales for its COVID-19 antiviral remdesivir during the first quarter, which helped offset declines for its HIV and hepatitis C drugs. Executives at the company said they anticipate remdesivir "will have an important role to play" over the next couple of quarters. The drug's share of the U.S. market remains strong: Roughly half of hospitalized COVID-19 patients now receive the antiviral, which continues to “play a key role as a standard of care treatment” for patients globally, Gilead chief Daniel O’Day said. Story
Emergent BioSolutions CEO Robert Kramer said he takes “full responsibility” for the mishaps at the CDMO’s plant in Baltimore, which discarded millions of doses of Johnson & Johnson’s COVID-19 vaccine following a production mishap. Following the incident, Emergent announced a number of executive changes during the company’s earnings call. Mary Oates, who joined Emergent after 25 years at Pfizer, is now handling the contract manufacturer's response to the FDA’s list of concerns at the Baltimore Bayview plant. Story
UPDATED: Friday, April 30 at 11:32 a.m.
Emergent BioSolutions has made more than 115 million doses of Johnson & Johnson's single-dose COVID-19 vaccine, with some 60 million shots loaded into vials and ready for delivery, a person close to the matter told Bloomberg. The FDA has yet to clear those doses for release, however, and with a majority of American adults now vaccinated, new immunizations are slowing. Emergent has been under an intense spotlight after workers at its Baltimore plant mixed up ingredients for AstraZeneca and J&J's shots, ruining a batch that contained up to 15 million J&J doses.
Pfizer exported the first U.S.-made doses of its BioNTech-partnered vaccine this week, starting with deliveries to Mexico. The country has locked up 10 million Pfizer doses so far and said it expected to receive 2 million doses this week, though it's unclear how much of that shipment was made in the U.S., Reuters reports. As the U.S. makes headway on its vaccination drive, it's faced mounting pressure to re-distribute surplus shots to other countries.
Argentina met with AstraZeneca to talk about "possible difficulties" in its vaccine production there, Reuters reports, citing the country's health minister, Carla Vizzotti. During the meeting, Vizzotti also pressed AZ to lock down an estimated delivery schedule for the shots. Argentina last year struck a deal to receive roughly 22 million AZ doses, which it planned to produce locally and send to Mexico and the U.S. for finishing.
The U.K.'s drug regulator on Thursday said it had received another 41 reports of rare blood clots in people after they received AstraZeneca's COVID-19 vaccine. In an update this week, the Medicines and Healthcare products Regulatory Agency said it was aware of a total of 209 clots with low platelet counts linked to the shot, up from 168 cases reported last week. The EMA has said AZ should list clotting as a "very rare" side effect of the shot. Meanwhile, the U.K. has instructed people under the age of 30 to seek out an alternative vaccine.
Companies working on COVID-19 shots handed their executives some hefty pay packages in 2020, and Novavax, targeting an emergency nod for its protein-based vaccine candidate later this year, is no exception. President and CEO Stanley Erck reeled in roughly $48.09 million, while the company's R&D lead, Gregory Glenn, M.D., scored $24.92 million, according to the company's 2021 proxy statement.
UPDATED: Thursday, April 29 at 3:20 p.m.
The European Medicines Agency (EMA) said it will quickly review Eli Lilly's rheumatoid arthritis drug Olumiant, also known as baricitinib, for emergency use in hospitalized COVID-19 patients receiving oxygen. The regulator, which will review data from two randomized trials of hospitalized patients, told the news agency it expects a decision by July.
Israel’s Teva likely won’t strike a co-production deal with COVID-19 vaccine makers, although discussions are still ongoing, CEO Kare Schultz told Reuters. The company, which has the capacity to produce the shots in Israel and Europe, has offered to help, but “the key players that have actually been successful in developing the vaccines that have come to the market have found other partners or their own internal capacity,” Schultz said.
Moderna has increasingly heard from a mix of governments, public health officials and scientists that mRNA vaccines are the best way forward as variants of the coronavirus emerge, president Stephen Hoge, M.D., told Fierce Pharma in an interview. That's because as variants spread, drugmakers are forced to "update their vaccines really quickly," and mRNA offers the necessary speed for that response, Hoge said. Story
Total global spending on COVID-19 vaccines is projected to reach $157 billion through 2025, according to an annual forecast from IQVIA Institute for Human Data Science. This year alone, IQVIA projects spending of roughly $53 billion and $51 billion in 2022. The group sees a precipitous drop in total spending in 2023, to roughly $23 billion. Story
The European Union’s latest supply contracts for COVID-19 vaccines to be delivered in the next couple of years now have clear rules on what will happen if drugmakers fall short on their deliveries, Germany’s Health Minister Jens Spahn said. The EU took legal action against AstraZeneca this week for not adhering to its contract and providing a “reliable” plan to ensure timely deliveries.
UPDATED: Thursday, April 29 at 9:25 a.m.
Moderna said it’s ramping up its vaccine manufacturing and will boost its supply estimates as a result. The biotech said it’s now able to make up to 3 billion doses in 2022 and raised its bottom forecast this year from 700 million doses to 800 million. The company also announced that new data shows its vaccine can be safely stored at refrigerated temperatures for up to three months. Story
BioNTech’s CEO Ugur Sahin said he expects results by September from trials testing the company’s mRNA vaccine, developed alongside Pfizer, in babies as young as six months old, Reuters reports, citing an interview Sahin conducted German magazine Spiegel. Results from trials testing the vaccine in kids between the ages of five and 12 will be available in July, Sahin said.
Spanish pharmaceutical company Reig Jofre will begin manufacturing doses of Johnson & Johnson’s COVID-19 vaccine by the end of the second quarter. At the company’s new plant in Barcelona, Reig said it will be able to produce as many as 250 million doses annually.
French prosecutors have opened an involuntary manslaughter probe into three deaths among recipients of AstraZeneca’s COVID-19 vaccine, AFP reports. The prosecutors, who are taking over and combining three local cases, haven’t charged any entity or individual yet. According to the prosecutor's office, plaintiffs are trying to determine whether the vaccine caused the deaths of their loved ones.
Roche said it’s seeking a fast-tracked emergency authorization for its COVID-19 antibody cocktail, a combination of casirivimab with imdevimab, in India and can begin supplying the country with the drug immediately once given the OK, the Business Standard reports. Roche is also expanding production of its arthritis med Actemra, which has shown mixed results in treating COVID-19 patients.