A new COVID-19 variant, the omicron variant, could soon cause a global surge, the World Health Organization said.
Those who received the Johnson & Johnson vaccine are often opting for other vaccines as a booster.
The worldwide case count stood at more than 261.7 million Monday morning, with more than 5.2 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.
UPDATED: Monday, November 29 at 10 a.m.
A new variant of COVID-19, the omicron variant, was discovered in South Africa last week. The WHO said the variant could quickly surge around the globe with "severe consequences," USA Today reports. The WHO said no deaths linked to the omicron variant have been reported, and there is currently no information that suggests symptoms differ from those associated with other variants.
The new variant caused the World Trade Organization's new director, Ngozi Okonjo-Iweala, on Friday to postpone indefinitely the organization's conference scheduled for Tuesday in Geneva. The goal of the meeting was to reach a compromise among nations over vaccine patents, Politico reports.
The FDA has issued a clinical hold on biopharma Ocugen, Inc.'s investigational new drug application for its COVID-19 vaccine candidate, COVAXIN.
As more and more people receive their booster shots, many who received Johnson & Johnson's single-dose vaccine are opting for a different vaccine for their booster, The Wall Street Journal reports. Of the 15.7 million people who got Johnson & Johnson's vaccine, about 1.7 million have received an additional dose. Of those, 26% stayed with Johnson & Johnson for their second dose, the CDC reported. Some 31% received a Pfizer-BioNTech booster, and 43% got the Moderna vaccine. Meanwhile, a majority of those who received the Moderna or Pfizer-BioNTech vaccine stuck with the same shots for their boosters.
UPDATED: Wednesday, November 24 at 10 a.m.
Johnson & Johnson's single-dose COVID-19 vaccine has been granted full approval by Health Canada, its first major regulatory approval, MarketWatch reports. In the U.S., it has only been granted emergency use authorization so far.
GreenLight Biosciences and Samsung Biologics announced an agreement for Samsung Biologics to manufacture GreenLight's mRNA COVID-19 vaccine candidate at commercial scale.
The U.S. could have access to a new antiviral pill from Merck within a few weeks and a second option from Pfizer to follow, Kaiser Health News reports. Both pills are under federal review now.
A man with an "obsessive interest in COVID-19" has been jailed after sending a suspicious package to a vaccine manufacturing site in Wrexham, Wales in January, sparking a bomb scare and halting manufacturing of the AstraZeneca vaccine. Anthony Collins, 54, from Chatham, Kent, was convicted Wednesday, BBC reports.
UPDATED: Tuesday, November 23 at 4 p.m.
The Justice Department filed a motion Tuesday urging the U.S. Court of Appeals for the Sixth Circuit, in Cincinnati, to lift a hold on the Biden administration's vaccine mandate for companies while it is being challenged in court, The New York Times reports. The federal mandate would start in January and mandates employers with more than 100 workers require vaccination or weekly testing.
AstraZeneca's CEO Pascal Soriot says differing hospitalization rates between the U.K. and the rest of Europe demonstrate that the AstraZeneca vaccine may provide longer-lasting protection against severe disease than rival mRNA shots. The heightened T-cell immunity afforded by the AstraZeneca vaccine works more effectively on those who contract the virus, CEO Pascal Soriot told the BBC on Tuesday. Story
WHO Europe, which is based in Copenhagen, Denmark, said projections show the 53-country region could face another 700,000 COVID-19 deaths by next spring, totaling 2 million, AP reports. Driving factors include the delta variant, the large number of people who remain unvaccinated and an easing of restrictive measures like mask requirements and social distancing.
UPDATED: Tuesday, November 23 at 10 a.m.
COVID-19 cases in children are surging. From about two weeks ago, cases in kids in the U.S. have risen by 32%, The New York Times reports. More than 140,000 children tested positive between Nov. 11 and 18, accounting for about a quarter of the country's caseload for the week and up from 107,000 cases the week ending Nov. 4.
The CDC added Germany and Denmark to its list of "very high" risk travel destinations as COVID-19 cases surge amid winter's onset, CNN reports. Last week, Germany reported a record single-day surge in cases.
UPDATED: Monday, November 22 at 4 p.m.
A House panel investigating former President Donald Trump's administration's response to the pandemic is calling former FDA Commissioner Stephen Hahn to appear for questioning. Hahn was involved in the FDA’s decision to approve hydroxychloroquine for emergency use during the pandemic, Politico reports.
A follow-up study of 2,228 kids ages 12 to 15 has shown the Pfizer-BioNTech COVID-19 vaccine to be 100% effective in preventing infection seven days to four months after the second dose. The results likely set the companies up for a full approval. Story
UPDATED: Monday, November 22 at 10 a.m.
The European Union's drug regulator said Monday it is evaluating Johnson & Johnson data on booster doses of its vaccine. A decision could come "within weeks," Reuters reports.
As Europe awaits the European Medicines Agency's decision on vaccines for children and countries seek booster shots, Germany is facing a dwindling supply of doses of the Pfizer-BioNTech vaccine, The New York Times reports.
Older people and those with underlying health conditions are most likely to get serious COVID-19 infections after full vaccination, The Wall Street Journal reports. Data shows there have been more than 1.89 million cases, at least 72,000 hospitalizations and 20,000 deaths this year among fully vaccinated people in the U.S.
UPDATED: Friday, November 19 at 4 p.m.
A CDC advisory committee has voted unanimously to open COVID-19 booster shots by Moderna and Pfizer to those age 18 and older. The vote upholds the FDA's approval earlier in the day. The recommendations now await CDC director Rochelle Walensky's final approval. Story
The FDA asked a federal judge for 55 years to complete a FOIA request for data and information on the approval of Pfizer's COVID-19 vaccine. Story
Austria reinstated a national lockdown as cases surge and became Europe's first country to mandate vaccines nationwide for all eligible people, CNN reports. Chancellor Alexander Schallenberg said the national vaccine requirement will start in February. The lockdown starts Monday and will last for 10 days minimum, and could be extended for a further 10 days.
UPDATED: Friday, November 19 at 10 a.m.
The FDA authorized additional shots of the Moderna and Pfizer-BioNTech vaccines as boosters for all U.S. adults, CNBC reports. The CDC still has to approve distribution of the doses before they can be administered. The CDC panel is set to meet later today to review new data, and its director, Rochelle Walensky, said Wednesday the agency would "act swiftly" after the FDA's authorization.
Clinical trials for CureVac's second-generation COVID-19 vaccine are expected to begin within the next few months, Reuters reports.
The Pan American Health Organization warned overuse of antibiotics during the COVID-19 pandemic is helping bacteria develop resistance to important medicines, Reuters reports.
UPDATED: Thursday, November 18 at 4 p.m.
Italy will acquire 50,000 courses of Merck and Pfizer's COVID-19 antiviral drugs, Reuters reports. Italy's COVID-19 Special Commissioner was given a mandate by the health ministry to acquire the courses.
Pfizer officially struck a deal to sell its investigational COVID-19 antiviral to the U.S. for $5.29 billion. Under the agreement, Pfizer will deliver 10 million courses of the oral therapy, starting this year and wrapping up in 2022. Story
UPDATED: Thursday, November 18 at 9:30 a.m.
As with a similar request from Pfizer, Moderna has asked federal regulators to approve booster shots of its COVID-19 vaccine for all adults. The FDA could grant authorization as early as this week, The New York Times reports.
A clinical trial of AstraZeneca's antibody treatment showed the drug to be 83% effective at preventing symptomatic cases of COVID-19 in people who may not respond well to vaccines compared to those who were given a placebo, CNBC reports. A separate trial showed patients with mild-to-moderate cases who were given the antibody within three days of developing symptoms had their risk of developing severe disease reduced by 88%.
UPDATED: Wednesday, November 17 at 4 p.m.
The European Medicines Agency has started reviewing an application for conditional marketing authorization for Novavax's COVID-19 vaccine, Nuvaxovid, continuing its rolling review of the vaccine. A decision could come within weeks if the data submitted are complete enough to show efficacy, safety and quality of the vaccine, the agency said.
Following the CDC's authorization of the Pfizer-BioNTech vaccine for children two weeks ago, the White House said 2.6 million kids, about 10% of 5-to-11-year-olds in the U.S., have received their shots as of Wednesday.
Six months after gaining FDA authorization for their COVID-19 antibody, GlaxoSmithKline and Vir Biotechnology have secured a U.S. supply deal. The U.S. will pay $1 billion to expand access to sotrovimab throughout the country. Story
UPDATED: Wednesday, November 17 at 9:30 a.m.
The FDA is set to expand eligibility for additional doses of Pfizer-BioNTech's vaccine to all adults as soon as Thursday. The move would increase the number of Americans eligible for extra doses by tens of millions, The New York Times reports. With FDA approval, those who received a second dose of the vaccine at least six months ago would be eligible. Additionally, the CDC's independent committee has scheduled a meeting for Friday to discuss data on booster efficacy and safety.
Roche is walking away from its collaboration with Atea Pharmaceuticals to develop an oral COVID-19 antiviral. However, Atea currently has no plans to ditch the drug and said it is still working on its phase 3 trial. Story
In Japan, Daiichi Sankyo has begun a phase 2 trial of its mRNA COVID-19 vaccine as the first patient has been dosed. The trial will be conducted in 80 unvaccinated, healthy adults, the company said.
UPDATED: Tuesday, November 16 at 4 p.m.
Pfizer filed an emergency use authorization request to the FDA for its COVID-19 oral antiviral for high-risk patients, the company said Tuesday. A phase 2/3 study of the pill, Paxlovid, showed it reduced the risk of COVID-19-related hospitalization or death by 89%.
The Biden administration is planning to buy 10 million courses of Pfizer's COVID-19 pill, The Washington Post reports, citing two people close to the matter. The deal is expected to ring in at roughly $5 billion. Story
UPDATED: Tuesday, November 16 at 10 a.m.
Moderna entered an agreement to expand access to COVID-19 resources. The company will allow the European Union and European Economic Area countries to donate more than 70 million doses of its vaccine to low income countries under COVAX.
Pfizer entered a licensing agreement with a United Nations-backed group to allow its COVID-19 pill to be made and sold cheaply in low- and middle-income countries. The company granted a license for the antiviral to the Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, or about 53% of the world's population, Pfizer said. Story
Following Colorado, California and New Mexico, Arkansas is the latest state to expand eligibility for booster shots to all adults, The New York Times reports.
UPDATED: Monday, November 15 at 4 p.m.
Ahead of the holiday season and colder weather, New York City health officials encouraged all adults who want to receive a vaccine booster to seek them out and health providers should give them, The New York Times reports. Dr. Dave Chokshi, the city’s health commissioner, said those 18 or older and seeking a booster should not be turned away provided it has been at least six months since their second shot of the Pfizer or Moderna vaccine, or at least two months since they received the single-dose Johnson & Johnson vaccine. Health officials say those in New York City are deemed at risk of exposure. The move comes as federal regulators consider expanding eligibility for boosters and follows similar moves of states including Colorado and California.
A Texas doctor, Dr. Mary Bowden, has been suspended from treating patients at Houston Methodist Hospital for spreading COVID-19 misinformation and refusing to treat vaccinated patients, CBS reports.
In Europe, some countries are tightening restrictions for those who are unvaccinated. The Austrian government implemented a lockdown for those unvaccinated and older than 12, allowing them to only travel for work, school, to buy groceries and to get medical care, The New York Times reports. Italy is requiring vaccination, recent recovery from COVID-19 or frequent testing in order to work. In Germany, unvaccinated people will be mandated to obtain a negative COVID-19 test to travel on buses or trains.
UPDATED: Monday, November 15 at 9:30 a.m.
Following the CDC's endorsement of the Pfizer-BioNTech vaccine for children ages 5-11, some U.S. states are offering incentives, such as cash payments and lotteries, for the shots for children, The New York Times reports. The White House estimates more than a million children have received doses since the endorsement.
U.S. Surgeon General Dr. Vivek Murthy said if courts continue to block the White House's mandates for companies with 100 or more employees to require COVID-19 vaccines or receive weekly testing, it would be a "setback for public health," The New York Times reports.
After 20 months of restrictions, India has reopened its borders to travelers from 99 reciprocating countries as cases remain low and vaccination rates rise, Bloomberg reports.
UPDATED: Friday, November 12 at 4 p.m.
Following Colorado, California is the second state to broaden eligibility for additional COVID-19 vaccine shots to include anyone 18 or older, The New York Times reports. The move extends access beyond older adults and people at high risk. Additional shots can be administered six months after the second dose of the Pfizer-BioNTech or Moderna vaccines and two months after Johnson & Johnson’s single shot.
The House Select Subcommittee on the Coronavirus Crisis released to CNN Friday new evidence on how CDC officials were pressured by former-President Donald Trump's administration officials to alter scientific guidance and prevented communication with the public. In transcripts from conversations and briefings with CDC officials and White House officials, CDC officials described how requests to hold briefings about mask guidance and pediatric cases and deaths were denied, CNN reports.
The European Medicines Agency has recommended COVID-19 antibody treatments from Roche-Regeneron and Celltrion for approval, nearly a year after the U.S. authorized the former. Story
UPDATED: Friday, November 12 at 10 a.m.
Shifting away from its nonprofit approach, AstraZeneca plans to start selling its COVID-19 vaccine at profit starting in 2022, The Wall Street Journal reports. The pharma giant will price its vaccine to make it profitable as it signs new contracts to allow it to make money off the shot. AstraZeneca expects some earnings contribution from new orders in the last quarter of 2021.
Colorado Gov. Jared Polis signed an executive order declaring the state is at high risk from exposure amid surging case numbers. Polis then urged all adults to receive additional shots of the Pfizer/BioNTech or Moderna vaccines if they are at least six months past the second dose or the Johnson & Johnson vaccine if two months past the single-dose shot, The New York Times reports.
In Austria, Chancellor Alexander Schallenberg said Friday the government should give the green light on Sunday for a nationwide lockdown for those who are unvaccinated, CNN reports.
UPDATED: Thursday, November 11 at 4 p.m.
The European Medicines Agency recommended a rare type of spinal inflammation, transverse myelitis, be added to the label of Johnson & Johnson's COVID-19 vaccine. Its vaccine label in the U.S. already warns of the possibility of a rare blood clotting disorder that occurs alongside excessive bleeding as well as of Guillain-Barre syndrome. Story
Ten states filed a lawsuit against the Biden administration's vaccine mandate for healthcare workers. The lawsuit follows a similar one filed by states last week over the White House's mandate for employees of companies with 100 or more employees. Story.
UPDATED: Thursday, November 11 at 10 a.m.
In an effort to increase access to vaccines, Johnson & Johnson entered into an agreement with the U.S. government to provide its single-shot vaccine through the COVAX Humanitarian Buffer to vulnerable populations throughout the world. Deliveries to the COVAX Humanitarian Buffer are expected in the coming days.
Moderna defended use of its COVID-19 vaccine Thursday, saying the protection against severe cases, hospitalization and death outweighs the risk of myocarditis, CNBC reports. While Moderna said the vaccine has fewer breakthrough cases than the Pfizer/BioNTech vaccine, reported cases of the rare heart inflammation in men under 30 are relatively higher in the Moderna vaccine, the company said. Moderna announced last week the FDA needed more time to discuss whether to authorize its vaccine in children ages 12-17 as the agency looks into the risk of myocarditis.
A federal judge ruled that Texas Gov. Greg Abbott's ban on mask mandates in state schools violates the rights of students with disabilities, The New York Times reports. This clears the way for districts to issue their own rules when it comes to masks.
World Health Organization data showed Europe had over half of the world's COVID-19 deaths in the first week of November. COVID-19 deaths in Europe rose 10% that first week, The New York Times reports.
UPDATED: Wednesday, November 10 at 4:15 p.m.
Pfizer CEO Albert Bourla said people who spread vaccine disinformation are "criminals," The Washington Post reports. Bourla also said a "very small" group has been responsible for spreading disinformation about COVID-19 vaccines to those still hesitant about the vaccine.
Speaking of being hesitant, new Deloitte research finds personal connections may be the most effective approach to boost current flu and COVID-19 vaccination efforts. In a survey of 3,000 U.S. adults, Deloitte found 59% of those who were previously hesitant say they got vaccinated because of family and friends compared to only 5% who said they were motivated by an incentive, such as free tickets, meals or paid time off.
Following France, Germany also recommended people under 30 should only receive the Pfizer/BioNTech vaccine due to lower risk of heart inflammation compared to Moderna, Reuters reports. The advisory committee made a similar recommendation for pregnant women.
Japan is the latest country to buy Merck's antiviral pill. Japan's government will buy 1.6 million courses of molnupiravir for about $1.2 billion, Reuters reports.
UPDATED: Wednesday, November 10 at 10 a.m.
With cases on the rise, the European Medicines Agency is set to authorize monoclonal antibody therapies from Regeneron-Roche and Celltrion, Reuters reports. The decision is expected in the coming days, two EU sources told the news service.
The White House is set to unveil its deal to get more doses of the Johnson & Johnson vaccine into conflict zones around the world, an official told Axios. It continues the Biden administration's efforts to get the rest of the world vaccinated. Due to liability concerns, Johnson & Johnson doses could previously only be used for official government vaccination programs, Axios reports.
The European Commission has agreed to purchase up to 60 million doses of Valneva's inactivated COVID-19 vaccine candidate over two years. The deal is contingent on a vaccine approval from Europe's drug regulator.
UPDATED: Tuesday, November 9 at 4 p.m.
Moderna and the National Institutes of Health are at odds over which inventors deserve vaccine patent rights for a certain component of the mRNA vaccine. Moderna's patent application names several employees as inventors but leaves out three government scientists, The New York Times reports. The vaccine was created by a collaboration between Moderna and the NIH. The conflict could have broad implications for future profits and the vaccine's long-term distribution.
In France, the country's public health authority advised against the Moderna vaccine for those under 30 due to concerns over risks of heart-related problems, Reuters reports. Instead, the agency has recommended people under 30 be given the Pfizer/BioNTech vaccine when available.
UPDATED: Tuesday, November 9 at 10 a.m.
Moderna filed a request to the European Medicines Agency Tuesday to expand usage of its COVID-19 vaccine in Europe to children ages 6-11 at a half dose, Politico reports. It is the first submission for use of the vaccine in this age group, Moderna CEO Stéphane Bancel said.
Merck and Ridgeback Biotherapeutics said that the U.S. will buy an additional 1.4 million additional courses of Merck's COVID-19 antiviral, molnupiravir, for about $1 billion if the pill is granted emergency use authorization or approval by the FDA. In total, the U.S. has now pledged to purchase about 3.1 million courses of the drug for about $2.2 billion. Story
Speaking of molnupiravir, Bangladeshi drugmaker Beximco will soon sell the first generic version of Merck's pill, Reuters reports.
In Singapore, the country will no longer cover medical costs for COVID-19 patients who are eligible to get vaccinated but decline to be, The New York Times reports. The move will begin Dec. 8.
UPDATED: Monday, November 8 at 4 p.m.
Following the lawsuit 11 states filed against the Biden administration over its latest vaccine mandate for companies with 100 or more employees, the White House is "prepared to defend" the rules, Dr. Vivek Murthy, the surgeon general, said Sunday. The mandate, set to take effect Jan. 4, was temporarily blocked by a federal appeals panel, The New York Times reports. The court ordered the Biden administration to respond by 5 p.m. Monday to a request for a permanent injunction.
The global COVID-19 case count has topped 250 million. Russia and eastern Europe are seeing infections at record levels, Reuters reports.
Also in Europe, the European Union's medicines regulator said Monday it will provide its recommendations for Merck's COVID-19 antiviral pill in the "shortest possible" time frame, Reuters reports.
UPDATED: Monday, November 8 at 9:30 a.m.
The U.S. lifted its travel ban Monday for fully vaccinated travelers from dozens of countries after 18 months of restrictions, The New York Times reports. Under the new travel rules, travelers must show proof of vaccination and negative COVID-19 test taken within three days prior to enter the U.S. Unvaccinated Americans and children under 18 are exempt from the requirement but are required to take a test within one day of travel.
India ordered 10 million doses of Zydus Cadila's COVID-19 vaccine at about $4 per dose. The three-dose vaccine won approval from the country's drug regulator in August for emergency use in people 12 and older, Reuters reports.
Regeneron said its antibody cocktail reduced the risk of contracting COVID-19 by 81.6% in the two-to-eight months period following the first dose in a late-stage trial. Story
UPDATED: Friday, November 5 at 4 p.m.
Following a similar lawsuit filed Tuesday, 11 attorneys general, 10 Republicans and one Democrat, filed a lawsuit Friday to stop the White House's new mandate requiring employers with more than 100 workers to ensure employees are vaccinated or receive weekly testing, The Wall Street Journal reports. The attorneys general said the mandate will hurt businesses and worsen the job market.
The U.S. cut ended a production contract with the troubled COVID-19 vaccine manufacturer Emergent. The manufacturer ruined millions of doses and had to halt production for months over quality concerns, The New York Times reports.
UPDATED: Friday, November 5 at 10:30 a.m.
Novavax submitted its application for emergency use listing for its COVID-19 vaccine to the World Health Organization.
The EU is reviewing data on AstraZeneca COVID-19 vaccine booster shots to determine whether it will authorize boosters for the vaccine, Reuters reports. European regulators have already given the green light to mRNA booster shots for the Pfizer/BioNTech and Moderna vaccines.
Pfizer said its experimental pill reduced the risk of hospitalization and death from COVID-19 by 89% for high-risk patients in a trial, CNN reports. The company hopes it can offer the pill, in combination with an older antiviral ritonavir, to people to take at home before hospitalization.
The FDA declined emergency use authorization for NRx Pharmaceuticals' therapy Zyesami. The FDA cited insufficient data for the benefits of the treatment versus the risk in COVID-19 patients with respiratory failure, Pharmafile reports. The drug aims to treat critical COVID-19 patients.
A Florida legislature panel authorized a $1.2 billion funding request by the state's Division of Emergency Management to respond to the pandemic. Part of it includes $643.4 million to go toward a "precautionary" stash of 300,000 doses of GlaxoSmithKline's sotrovimab, a monoclonal antibody treatment, The Apopka Voice reports. Gov. Ron DeSantis sponsored the funding request and said he wants the state to acquire sotrovimab as a precaution after the state was purposely shorted after the Biden administration rationed supplies of Regeneron's monoclonal antibody treatments.
UPDATED: Thursday, November 4 at 3:45 p.m.
Dr. Hans Kluge, World Health Organization director for the 53 countries in its European region, said Europe is back at the epicenter of the pandemic. The region is again seeing near-record levels of COVID-19 cases, accounting for 59% of the world's newly reported cases last week, The New York Times reports. Europe could experience half a million COVID-19-related deaths in the next three months, WHO said.
Elsewhere, China is also working to contain an outbreak that has reached 19 of its 31 provinces. It is the most widespread outbreak since the first wave of infections that began in Wuhan in 2019, CNN reports.
Shipping delays are taking a toll on Moderna's growth. International shipments of its COVID-19 vaccine doses are requiring "longer delivery lead times" than earlier batches. Story
UPDATED: Thursday, November 4 at 10 a.m.
U.K. regulators authorized Merck's antiviral pill, molnupiravir, to treat COVID-19. It is the first country to OK the treatment. The pill, licensed for adults 18 and older who have tested positive for COVID-19, reduces symptoms and speeds recovery.
The Biden administration issued a federal mandate stating that U.S. companies with more than 100 employees must require COVID-19 vaccines or weekly testing, Bloomberg reports. The requirement is set to take effect Jan. 4.
UPDATED: Wednesday, November 3 at 4 p.m.
Following the CDC's approval Tuesday, dozens of healthcare sites around the U.S. began administering first doses of the Pfizer/BioNTech vaccine to elementary school-age kids. Hundreds more sites are expected to in the coming days as part of the effort to get this next group of eligible people vaccinated, USA Today reports.
In Colorado, hospitals are nearly full as the state experiences its worst COVID-19 wave in a year, The New York Times reports. Gov. Jared Polis signed an executive order Sunday to allow hospitals to redirect incoming patients as they face staffing shortages and overwhelmed facilities. Hospitalizations in Colorado have increased 14% in the last two weeks as the state's daily case count reached its highest level since peaking in November 2020.
UPDATED: Wednesday, November 3 at 10 a.m.
The CDC gave the final signoff Tuesday evening for using the Pfizer-BioNTech vaccine in a lowered dose for children ages 5-11. The decision expands vaccine recommendations to about 28 million children in the U.S.
A study of patients within the Mayo Clinic Health System showed the Johnson & Johnson vaccine is 73.6% effective, CNN reports. The research looked at almost 9,000 patients vaccinated with the Johnson & Johnson vaccine and nearly 89,000 unvaccinated patients to see how many tested positive for COVID-19.
A World Health Organization independent advisory panel, the Technical Advisory Group, granted emergency use listing approval for Bharat Biotech's Covaxin vaccine, Times of India reports. The approval comes after WHO delayed its decision, seeking additional assessments. Covaxin has showed to be 77.8% effective against symptomatic COVID-19 and 65.2% against the delta variant.
Following Merck's deal with the United Nations-backed Medicines Patent Pool to allow more companies to manufacture generic versions of its antiviral molnupiravir, the company has also signed eight deals to sell more than 2 million courses of the pill to governments around the world. Merck has applied for approval in the U.S. and said it can make 10 million courses in 2021, Reuters reports.
UPDATED: Tuesday, November 2 at 4 p.m.
The CDC's vaccine advisors are expected to vote on whether to recommend use of the Pfizer/BioNTech vaccine for children ages 5 to 11 later Tuesday. The panel's meeting is ongoing and is one of the last remaining regulatory steps before shots could be administered, CBS reports.
Dr. Anthony Fauci said it is expected everyone will need additional doses eventually, and Pfizer and Moderna boosters could soon be available to all Americans by winter, ABC reports. Currently, boosters are available to seniors, plus those who are immunocompromised and those who can be exposed to the virus at work.
Following Florida's lawsuit, more states are teeing up against the Biden administration's federal mandate for federal contractors to be vaccinated by Dec. 8. Ten Republican-led states, including Alaska, Arkansas, Iowa, Missouri, Montana, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming, have filed a lawsuit in federal court in Missouri accusing the White House of various overreaches, The New York Times reports. Missouri Attorney General Eric Schmitt and Nebraska Attorney General Doug Peterson led the filing.
UPDATED: Tuesday, November 2 at 10 a.m.
Eli Lilly will supply 614,000 additional doses of its COVID-19 treatment bamlanivimab and etesevimab to the U.S. government before February 2022 for $1.29 billion. The antibody therapies are authorized for emergency use treatment of mild to severe COVID-19 or for post-exposure prophylaxis of COVID-19 in some individuals. Story
A potentially faster-spreading COVID-19 delta variant, named AY.4.2, has been spotted in labs in at least 8 states, CBS reports. Labs in California, Florida, Maryland, Massachusetts, Nevada, North Carolina, Rhode Island, Washington and Washington, D.C., have identified at least one case of AY.4.2. Health authorities say current vaccines are effective against it and that they have not found evidence of more severe cases caused by the variant. In the U.K., health authorities are looking into a number of cases from this strain.
As deadlines loom for the military to get mandated COVID-19 vaccines, the Pentagon says it is up to unit commanders on a "case-by-case" basis to make exemption decisions for medical, religious and administrative reasons, AP reports.
UPDATED: Monday, November 1 at 3:30 p.m.
The U.S.'s vaccination program for children ages 5-11 will be "running at full strength" next week, White House Coronavirus Response Coordinator Jeff Zients said Monday. More than 15 million doses of the Pfizer/BioNTech vaccine for that age group will be transported to distribution centers, CNN reports. Starting the week of Nov. 8, the kids' vaccination program will be fully up and running.
According to guidance the White House released Monday, federal contractors will have broad leeway to enforce the federal vaccine mandate, giving them flexibility to determine how they enforce the vaccination requirements for workers who refuse to be vaccinated, CNBC reports.
COVID-19 cases are on the rise again in Europe amid eased restrictions and approaching colder weather. From Oct. 18-24, Europe reported more than half the world's new confirmed cases, a World Health Organization report said. It was the only region that saw increases in both new infections and deaths, The New York Times reports.
UPDATED: Monday, November 1 at 10 a.m.
The Novavax COVID-19 vaccine has received its first regulatory go-ahead: emergency use authorization in Indonesia. Novavax announced the news along with its manufacturing partner, the Serum Institute of India.
Novavax also reported more positive news on the shot, saying it has completed submissions to Health Canada and the European Medicines Agency. The data included in the submissions show that in a trial of 30,000 in the U.S. and Mexico, the shot provided 100% protection against moderate and severe disease and 90% efficacy overall. The developments come after the company has had trouble hitting its timeline targets because of manufacturing issues. Despite coming late to the vaccine party, the protein-based shot has a chance to thrive, especially in lesser-developed countries, because it doesn’t have the cold-storage requirements of the mRNA vaccines produced by Pfizer/BioNTech and Moderna.
In response to the news, Novavax shares jumped 9.5% by the late morning on Monday. “We are keenly awaiting approvals from the WHO and U.K., as we believe sign-off by these agencies will facilitate a rapid global rollout,” wrote Jefferies analysts in a note to investors. Jefferies points out that the WHO has approved seven vaccines, and the EU has approved four of the 10 vaccines that have been authorized in Indonesia, suggesting the approval is a “positive sign but not a guarantee of approval from major regulatory agencies.”
The FDA called for more time to review Moderna's emergency use authorization request for its COVID-19 vaccine for adolescents ages 12-17. The FDA said the review may not come before January 2022. The agency needs more time to evaluate recent international research of the risk of myocarditis after vaccination.
As New York City's mandate to require vaccination for city department workers including police officers, firefighters and other city employees arrived, the city saw a sharp increase in vaccinations among New York workers, The New York Times reports.
UPDATED: Friday, October 29 at 4 p.m.
Following the advisory committee's recommendation, the FDA authorized the Pfizer/BioNTech vaccine for children ages 5 to 11. It is the first vaccine cleared for use in the U.S. for children as young as 5,. The vaccine now awaits the CDC's signoff for kids. Story.
A new CDC study suggests vaccination provides people with more protection against COVID-19 than a past infection, The New York Times reports. The CDC said unvaccinated people who had previously recovered from infection were five times as likely to get COVID-19 than those fully vaccinated with the Pfizer/BioNTech or Moderna vaccines.
About 50,000 students have dropped from enrollment in New York City's public school system since fall 2019, the Department of Education said Friday. The decline is likely driven by various factors, including parents choosing to home-school kids and moving away from the city, The New York Times reports.
UPDATED: Friday, October 29 at 10 a.m.
The CDC added mental health illnesses including depression and schizophrenia to its list of health conditions that make people more likely to become severely ill with COVID-19. With that decision, about 85% of the adult U.S. population is now eligible for additional vaccine doses, The New York Times reports.
In Iowa, legislators passed a bill to allow unemployment benefits for those fired over noncompliance with vaccine mandates. The bill also broadened religious and medical exemptions from immunization, The Washington Post reports.
UPDATED: Thursday, October 28 at 4 p.m.
With the success of Merck's antiviral molnupiravir thus far, the company plans to produce 10 million courses of the treatment by the end of this year and at least 20 million next year. Merck said Thursday, as the company reported third-quarter earnings. The 2022 figure only takes into consideration Merck’s in-house production. As part of its deal with the United Nations-backed Medicines Patent Pool, the group will provide the treatment to 105 low- and middle-income countries. Story
Alabama Gov. Kay Ivey issued an executive order this week ordering state officials to not enforce federal vaccine mandates. The White House ordered to require all federal employees, federal contractors and people who work for healthcare companies receiving Medicare and Medicaid to be vaccinated. Ivey called the requirements federal overreach, The New York Times reports.
Florida is following suit in opposition to the Biden administration's vaccine mandates. The state said Thursday it is suing the administration over its mandate for federal contractors, AP reports.
UPDATED: Thursday, October 28 at 9:30 a.m.
Some immunocompromised adults who received a third dose of either the Moderna or Pfizer/BioNTech vaccine will become eligible for a fourth shot as a booster next year, The New York Times reports. Federal regulators cleared a third dose in August.
The U.S. government bought an additional 50 million doses of the Pfizer/BioNTech vaccine following the authorization of the vaccine for children. Doses are expected to be delivered by April 2022 and help the U.S. prepare for pediatric vaccinations, including securing vaccines for children under 5, should they receive regulatory authorization.
A new study showed COVID-19 patients who received the widely available antidepressant fluvoxamine were significantly less likely to require hospitalization, The Wall Street Journal reports.
UPDATED: Wednesday, October 27 at 4 p.m.
GlaxoSmithKline is ending development of its antibody otilimab in COVID-19 in response to a midstage trial failure. Development of the drug in rheumatoid arthritis is continuing. Story
Following Novavax's request for authorization of its vaccine in the U.K., the company also said it will file a request to the FDA by the end of the year. The Maryland biotech originally aimed to submit to the FDA in May. Story
A new study suggests pregnant and breastfeeding women respond to COVID-19 vaccines slower than other women after the first dose but almost the same after a second dose, The New York Times reports.
A new Urban Institute study estimates $26.8 billion remains in the COVID-19 provider relief fund passed by Congress under the CARES Act last year. More money could be on the way as providers start to return unspent dollars. Story
UPDATED: Wednesday, October 27 at 9:45 a.m.
Novavax submitted a request for authorization of its COVID-19 vaccine in the U.K. The company's application for Conditional Marketing Authorization is the first submission for a protein-based COVID-19 vaccine in the U.K. Novavax has submitted all data required by the U.K. Medicines and Healthcare products Regulatory Agency, including data from its phase 3 trial of 15,000 volunteers, the company said.
Merck has signed a licensing agreement with the United Nations-backed Medicines Patent Pool to expand manufacturing generic versions of its COVID-19 antiviral pill, Reuters reports.
BioNTech will build an mRNA vaccine manufacturing plant in Africa in mid-2022 to scale production of its COVID-19 vaccine. The Pfizer partner could beat Moderna in building the first mRNA vaccine manufacturing site on the continent. Story
In the Czech Republic, more than 6,000 new COVID-19 cases were reported, a first for the country since April, Reuters reports.
UPDATED: Tuesday, October 26 at 4:30 p.m.
Following a long discussion, the FDA advisory committee panel voted Tuesday afternoon to recommend the emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine for children ages 5-11. Of its 18 voting members, 94% voted yes, while Dr. Michael Kurilla abstained.
A study of more than 32 million vaccine recipients in England showed that people given the AstraZeneca vaccine were at a slightly increased risk of an extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), The New York Times reports. Although, researchers said the risk of the disorder is smaller than COVID-19 itself. U.K. drug regulators added the disorder as a potential side effect of the AstraZeneca vaccine last week.
UPDATED: Tuesday, October 26 at 10 a.m.
An FDA panel began meeting Tuesday to discuss whether to recommend a pediatric dose of the Pfizer/BioNTech vaccine for children ages 5-11. The federal advisory committee's decisions could lead to children getting shots as soon as next week, The New York Times reports.
Moderna entered an agreement with the African Union to offer its vaccine at the lowest tiered price as part of its commitment to improve global access to COVID-19 vaccines. The African Union plans to buy up to 110 million doses of the Moderna vaccine.
Elsewhere, France has ordered 50,000 doses of Merck's COVID-19 antiviral pill for adults, Reuters reports.
UPDATED: Monday, October 25 at 4 p.m.
Following news that the U.S. will lift travel restrictions on Nov. 8 for vaccinated travelers, the Biden administration announced Monday that unvaccinated children and some people from countries with low rates will be exempted from the new travel rules, The New York Times reports.
South Korea also loosened restrictions as President Moon Jae-in announced the country has now fully vaccinated 70% of its population, The New York Times reports.
In a continued effort to improve the availability of COVID-19 tests and support manufacturing of supplies needed for testing, the Biden administration, through the Department of Health and Human Services (HHS), has awarded a total of about $560 million to 13 companies including Thermo Fisher Scientific's Nalge Nunc as well as OraSure. Story
A study of 740 patients showed long-term COVID-19 side effects could include memory loss and other cognitive dysfunctions commonly labeled as "brain fog," USA Today reports.
UPDATED: Monday, October 25 at 9:30 a.m.
As Merck looks to provide access to its oral COVID-19 antiviral, molnupiravir, worldwide, the European Medicines Agency has started the rolling review process in anticipation of Merck filing a formal marketing authorization application once data are ready. This follows Merck's application for emergency use authorization to the FDA. Story
Moderna said Monday its vaccine showed positive results in children six to 11 years in a phase 2/3 study. The company plans to submit results to the FDA, EMA and other global regulators soon.
Vaccines for kids ages five to 11 will likely be available come November, Dr. Anthony Fauci said. The U.S. infectious disease expert said he could see many kids getting fully vaccinated by the end of the year, Reuters reports.
UPDATED: Friday, October 22 at 4 p.m.
The UK Health Security Agency moved a new mutated form of COVID-19, which some are calling "Delta Plus," to its "variant under investigation" category. Although there is no evidence yet that it causes worse illness and scientists are confident that existing vaccines should protect people, it may spread more easily than the regular delta variant, BBC reports.
India has now administered 1 billion doses of COVID-19 vaccinations despite a slow start. However, there is still a ways to go. The New York Times reported that 30% of India's 900 million people eligible for vaccination have received two doses.
The World Health Organization warned that several Caribbean countries are reporting significant surges in COVID-19 cases, The New York Times reports. Also outside the U.S., the British government warns for a possible need to reintroduce some restrictions in the country if vaccine booster rollout fails to contain the situation as case numbers increase. Despite calls for action, the government has not taken action yet.
Illinois Gov. J.B. Pritzker said its statewide indoor mask mandate could be lifted by the holidays if COVID-19 cases continue to decline, Forbes reports. The city of Chicago will only lift its mandate when daily cases drop below 200, compared to its average of 245 per day now. Meanwhile, California's Bay Area counties have lifted some indoor mask requirements in spaces like offices, gyms and religious gatherings.
UPDATED: Friday, October 22 at 10 a.m.
Following the FDA's nod for additional doses of the Moderna and Johnson & Johnson vaccines, the CDC followed suit and authorized the same recommendations. Boosters for all three vaccines available in the U.S., are now recommended.
As it seeks emergency use authorization for its vaccine in children, Pfizer and BioNTech said its COVID-19 vaccine was more than 90.7% effective at protecting children ages 5-11 from symptomatic infections, The Wall Street Journal reports.
UPDATED: Thursday, October 21 at 4 p.m.
The U.K. drug regulator added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), as a potential side effect of the AstraZeneca COVID-19 vaccine, Reuters reports.
During a CDC advisory meeting Thursday, officials said myocarditis rates are higher among 18- to 39-year-olds who received the Moderna vaccine than those who received the the Pfizer/BioNTech vaccine, CNBC's Meg Tirrell reports.
In Egypt, authorities mandated COVID-19 vaccines for all government employees, university students, teachers and people seeking any government services, The New York Times reports. The mandate comes as the country anticipates the delivery of more vaccine doses.
UPDATED: Thursday, October 21 at 10 a.m.
Data from a phase 3 trial showed an additional dose of the Pfizer/BioNTech vaccine demonstrated 95.6% efficacy. Investigators ran the trial when Delta was the primary strain, Pfizer said.
The FDA has authorized a booster dose of Moderna's COVID-19 vaccine, allowing it to play catch up with the Pfizer-BioNTech shot, which scored a booster approval last month. The agency also blessed a second dose of the Johnson & Johnson vaccine. That nod applies to adults who have received one J&J shot two months prior. Story
In Japan, pharmaceutical company Daiichi Sankyo touted progress in its development of a mRNA COVID-19 vaccine. The company will continue efforts following a successful phase 1/2 clinical trial.
UPDATED: Wednesday, October 20 at 4 p.m.
New documents released by Public Citizen show how Pfizer is using aggressive tactics when negotiating vaccine supply deals. The company is able to "silence" governments and "throttle supply" in an effort to "maximize profits," the group says. Story
Novavax is reportedly struggling to meet quality standards in its COVID-19 vaccine production push. The company reaped $1.6 billion from the federal government last year to develop and manufacture a COVID-19 vaccine. Story
Abbott Laboratories has shipped more than 1 billion COVID-19 tests since the start of the pandemic, Forbes reports.
UPDATED: Wednesday, October 20 at 9:30 a.m.
New York City will mandate COVID-19 vaccinations for all city workers and eliminate the option for testing, Bloomberg reports. Starting Wednesday, employees will receive an extra $500 in their paycheck if they get their first shot at a city-run site. The benefit will end on Oct. 29, which is the deadline for employees to submit proof of at least one dose. Employees not vaccinated by then will be placed on unpaid leave, Mayor Bill de Blasio said.
The Biden administration said it plans to make COVID-19 vaccines available at more than 25,000 pediatric offices and primary care sites—and at nationwide pharmacies—once they're authorized for children ages 5 to 11, The Wall Street Journal reports.
The Bill & Melinda Gates Foundation announced its commitment of up to $120 million to accelerate access to the Merck COVID-19 antiviral molnupiravir for lower-income countries if authorized by regulators.
COVID-19 vaccine output is estimated to reach over 12 billion doses by the end of 2021 and 24 billion by mid-2022. As G20 countries prepare to meet at the end of October, the biopharma industry is teaming up to increase supply efforts.
UPDATED: Tuesday, October 19 at 3:45 p.m.
The FDA is expected to allow Americans to use a different COVID-19 vaccine for a booster dose than they initially received following data from an NIH study, The New York Times reports. A ruling could come this week. Story
CDC data showed roughly 15% of seniors ages 65 and up received additional doses of their COVID-19 vaccines, CNN reports. About 10.7 million people total have received a booster shot.
The Pfizer/BioNTech vaccine was found to be 93% effective at preventing hospitalization among patients ages 12-18, MedPage Today reports.
UPDATED: Tuesday, October 19 at 10 a.m.
The European Medicines Agency is reviewing data on the Pfizer/BioNTech vaccine and evaluating use for it in children as young as 5, Reuters reports. The agency also approved two new production sites for the shot in Italy.
A World Health Organization-led program is aiming to buy COVID-19 antiviral pills for as little as $10 per course as part of the effort to ensure access to COVID-19 countermeasuers for low- and middle-income countries, Reuters reports. The goal is to enable access to new COVID-19 drugs for 120 million people.
Atea Pharmaceuticals said Tuesday its COVID-19 antiviral pill failed to combat the virus in a mid-stage trial. The company will delay its pivotal study by a year.
Biopharma InflaRx scored up to $50.7 million in grant money from the German government to advance the development of its vilobelimab treatment for severe COVID-19.
UPDATED: Monday, October 18 at 4 p.m.
Data from the CDC showed adults over the age of 65 make up 85% of breakthrough COVID-19 deaths, NBC reports.
Following the FDA advisory committee meetings, the CDC will meet this week to discuss additional doses of the Moderna and Johnson & Johnson COVID-19 vaccines, ABC7 reports.
UPDATED: Monday, October 18 at 9:45 a.m.
Following an FDA advisory panel's recommendation for a second Johnson & Johnson dose for recipients 18 and older, Dr. Anthony Fauci said the vaccine should have been a two-dose regimen from the start, USA Today reports.
Chicago Mayor Lori Lightfoot and the head of the city's largest police union, John Catanzara, are clashing over vaccination requirements as the city filed a complaint against the union, The New York Times reports. Catanzara urged police offices to ignore orders to report vaccination status. The city's complaint argues that the union was threatening an illegal strike.
A small vaccine developer, Valneva, said its own COVID-19 vaccine has spurred more antibodies than AstraZeneca's when pitted in a head-to-head trial.
The World Health Organization said it expects Indian biotech Bharat Biotech to provide more information on its COVID-19 vaccine Covaxin, Reuters reports. The response is a setback to the company's goal of getting emergency use authorization for the shot.
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.
The CDC is predicting the rate of COVID-19 deaths in the U.S. will decrease over the next four weeks. This is the first time since June deaths are projected to decrease, CNN reports.
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
Clover Biopharmaceuticals' COVID-19 vaccine candidate showed 79% efficacy against the delta variant in its phase 2/3 trial. 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 U.K.-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