AstraZeneca could try to skip over the emergency use authorization process at the FDA and instead focus on a full approval for its vaccine, the Wall Street Journal reports.
The EU finalized a supply deal with Pfizer and vaccine partner BioNTech for 1.8 billion doses of the companies' two-dose vaccine through 2023, European Commission chief Ursula von der Leyen said.
The worldwide case count stood at more than 158.4 million on Monday morning, with more than 3.2 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. Entries from Aug. 11 to Oct. 30 are here. Entries from April 21 through Aug. 11 are here. Entries from Jan. 30 through April 20 are here.
UPDATED: Monday, May 10 at 9:00 a.m.
AstraZeneca could potentially pass over its FDA application for emergency use for its COVID-19 vaccine and seek a full approval instead, The Wall Street Journal reports, citing people familiar with the matter. The move, which would take more time than an emergency nod, could further delay the shot’s rollout in the U.S. by months. The company has previously said it still intends to apply for emergency approval, although the Journal previously reported that AZ has run into trouble gathering data for its application from the millions of people already vaccinated in the U.K.
The European Union signed a contract with Pfizer and partner BioNTech for 1.8 billion doses of the companies’ two-dose vaccine, European Commission head Ursula von der Leyen said in a tweet. The deal, set for 2021 to 2023, is designed to cover booster shots, donations and the reselling of doses, Reuters reports.
The European Union has not placed additional orders for AstraZeneca’s COVID-19 vaccine beyond its current deal, which is set to end in June, European Internal Market Commissioner Thierry Breton said. However, Breton added that the company has “a very good vaccine” and that the bloc “will have other orders.” The EU launched legal action against AZ last month for not respecting its supply contract.
Eli Lilly said it signed licensing deals with three Indian generic drugmakers to expand the availability of its baricitinib, authorized to treat hospitalized COVID-19 patients when paired with remdesivir. The three drugmakers, Cipla, Lupin and Sun Pharma, will help Lilly manufacture and sell baricitinib, the company’s arthritis drug, in India, Reuters reports.
The GAVI Vaccine Alliance is in talks with China’s Sinopharm, which earned the World Health Organization's emergency backing late last week, and other vaccine makers for additional doses for the vaccine-sharing facility COVAX, a spokesperson told Reuters. So far, COVAX has been hampered by supply setbacks stemming from the Serum Institute of India after Indian authorities restricted exports.
UPDATED: Friday, May 7 at 2:50 p.m.
The World Health Organization issued emergency authorization for a COVID-19 vaccine from China’s state-owned drugmaker Sinopharm, a move that would allow the shot to be included in the vaccine sharing facility COVAX. Sinopharm’s two-dose vaccine is the first shot developed by a non-Western nation to win the WHO’s backing, Reuters reports.
The European Commission is nearing a supply deal with Pfizer for 1.8 billion doses of its two-shot vaccine for 2022 and 2023, Bloomberg reports, citing two people familiar with the matter. The EU closed its negotiations with the company last week and told ambassadors that the deal was ready for signatures on Wednesday. An announcement could come as early as Friday, according to the report.
Senior CDC official Nancy Messonnier, who was among the first high ranking health experts to warn Americans of the grave danger the coronavirus pandemic posed, is resigning from her position with the agency, The Washington Post reports, citing an internal agency email. Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases since 2016, was sidelined at the beginning of the pandemic after her comments angered former President Donald Trump. Messonnier will become executive director for pandemic and public health systems at the Skoll Foundation.
A European Medicines Agency's safety committee said it’s evaluating an assortment of potential side effects following inoculation with leading COVID-19 vaccines. Those concerns include cases of heart inflammation and facial swelling among Pfizer vaccine recipients, as well as reports of a rare nerve-degenerating disorder, known as Guillain-Barre syndrome, among people inoculated with AstraZeneca’s shot. Story
UPDATED: Friday, May 7 at 8:50 a.m.
Pfizer and BioNTech have initiated an FDA application to the FDA for full approval of their COVID-19 vaccine in people 16 and older. The companies said they will submit the required manufacturing and facility data for licensure to complete their application in the coming weeks. Since earning an emergency authorization in December, the companies said they’ve delivered 170 million doses of their two-shot vaccine.
Pfizer CEO Albert Bourla said he is “not at all” in favor of the Biden administration’s decision to endorse a controversial measure that would waive patent protections for COVID-19 vaccines, AFP reports. In an interview, Bourla said the problem is that there are “no facilities in the world outside the ones that we can build ourselves, that can make mRNA vaccines.” The Pfizer chief cautioned against disrupting current operations “with politically motivated announcements,” calling them empty promises.
The European Medicines Agency has started a rolling review of GlaxoSmithKline’s monoclonal antibody for the treatment of COVID-positive adults and adolescents, GSK said. The therapy, dubbed sotrovimab or VIR-7831, is intended for patients who don’t require supplemental oxygen but are at risk of severe disease.
Britain will offer people under the age of 40 an alternative to AstraZeneca’s COVID-19 vaccine following concerns of rare but serious blood clots, The Daily Telegraph and The Independent newspapers report. The Joint Committee on Vaccination and Immunisation (JCVI), an independent group of experts that advises the U.K. on vaccinations, suggested people in that age group be offered shots from Pfizer and Moderna out of "an abundance of caution.”
Japan could authorize the vaccines from AstraZeneca and Moderna as early as May 20, financial newspaper Nikkei reports. So far, Japan has only authorized the vaccine from Pfizer and BioNTech.
UPDATED: Thursday, May 6 at 2:40 p.m.
Moderna said a phase 2/3 trial studying its vaccine in adolescents aged 12 to 17 found the vaccine to be 96% effective with no serious safety concerns. The biotech is in discussions with federal regulators to amend its existing authorization to include that age group. Meanwhile, the company said it will begin the process for full FDA approval in adults this month. Story
Germany rejected the Biden administration’s decision to back a controversial intellectual property waiver for COVID-19 vaccines, saying the problem is with manufacturing and quality standards rather than patents. A government spokesperson told Reuters that IP protection is a “source of innovation and must remain so in the future.”
Moderna CEO Stéphane Bancel said he didn’t lose any sleep over the Biden administration’s decision to back the IP waiver proposal before the World Trade Organization. Even if the measure passed, drugmakers interested in manufacturing mRNA vaccines would need to conduct the clinical trials, apply for authorization and then scale up manufacturing, which could take upwards of 12 to 18 months, Bancel argued. Story
Novavax, nearing a possible emergency use filing for its COVID-19 vaccine, dropped more data on how its shot works against a particular variant. When pinned against the variant found in South Africa, better known as B.1.351, the vaccine’s efficacy hit 51% in HIV-negative subjects of a midstage trial. Meanwhile, efficacy dropped slightly in HIV-positive patients, to 43%, though given the nature of the disease and its impact on the immune system, this was not unexpected. Story
UPDATED: Thursday, May 6 at 8:35 a.m.
Pfizer and BioNTech will donate doses of their mRNA vaccine for athletes set to participate in the Tokyo Olympic Games in July and August. Doses will ship out later this month so athletes can be fully vaccinated before the games begin.
Moderna reported $1.73 billion in sales for its COVID-19 vaccine. The shot is one of the leading vaccines worldwide, but the sales figure is about half of what Pfizer reported earlier this week. That mRNA shot pulled down $3.5 billion during the first quarter. Story
On the therapeutic front, Regeneron said its antibody cocktail Regen-Cov generated $262 million during the first three months of the year. That figure trailed Regeneron's big-selling eye drug Eylea, which generated $1.347 billion, but it came in ahead of Regeneron's other medicines.
Novavax finalized its advance purchase deal with Gavi, the Vaccine Alliance to manufacture and deploy 350 million doses of its vaccine to COVAX-participating countries and economies. Aided by manufacturing partner Serum Institute of India, Novavax aims to start deliveries of a cumulative 1.1 billion doses of its shot to COVAX in the third quarter, assuming the vaccine passes muster with regulators.
With about 24,000 employees worldwide, Amgen is allowing many to continue working remotely for the foreseeable future. About 2,000 employees are still working on a daily basis at the company's California headquarters.
UPDATED: Wednesday, May 5 at 3:15 p.m.
Pfizer’s COVID-19 vaccine, produced alongside Germany’s BioNTech, has been authorized for use in adolescents aged 12 to 15 in Canada, the companies announced. The shot is the first to be authorized in the country for children in that age group. The drugmakers are also seeking to expand the use of their shot to adolescents in Europe and the U.S., where an FDA decision could come by early next week.
The Biden administration will support lifting intellectual property protections for COVID-19 vaccines, a move intended to ramp up global access, U.S. Trade Representative Katherine Tai said in a statement. The U.S., which has been an opponent of a measure presented to the World Trade Organization that would temporarily suspend IP rights, will now "actively participate" in the WTO discussion to pass the measure, Tai said.
Germany’s CureVac is on track to file its COVID-19 vaccine for authorization in Europe as early as this month as cases among its late-stage clinical trial participants quickly accrue, Chief Executive Franz-Werner Haas told Reuters.
Similar to warnings issued for Chinese state-owned drugmaker Sinopharm, a group of World Health Organization vaccine experts are now warning that some data from China’s Sinovac are also lacking. The WHO’s Strategic Advisory Group of Experts (SAGE) said in a report that while Sinovac’s shot appears effective, they have a “low level of confidence” over the risk of serious side effects in people above 60, as well as other groups at high risk from COVID-19.
A U.N. spokesperson told Reuters that Secretary-General Antonio Guterres believes vaccine developers should allow other companies to manufacture their shots. Guterres’ comments come as the World Trade Organization weighs a proposal set forth by South Africa and India to waive patent rights on COVID-19 vaccines to ensure greater access. However, some U.N. officials have called the discussions a “distraction” that won’t solve the world's manufacturing problems.
UPDATED: Wednesday, May 5 at 9:40 a.m.
Eli Lilly employees accused an executive at one of the company's factories of modifying documents required by federal regulators in an effort to downplay serious quality control problems at the facility, which produces Lilly’s COVID-19 antibody drug bamlanivimab, Reuters reports, citing an internal complaint document and a source familiar with the matter. The complaint argues that the executive rewrote findings from Lilly’s technical experts at its factory in Branchburg, New Jersey. Lilly confirmed the internal complaint with Reuters but said it couldn’t comment further since a third-party investigation was underway. Story
Indian regulators issued an emergency authorization for the COVID-19 antibody cocktail from drugmakers Roche and Regeneron, which is a combination of casirivimab with imdevimab. Roche last week said it would seek a fast-tracked authorization for the cocktail in India and said it could begin supplying the drug immediately once given the OK.
World Health Organization experts voiced “very low confidence” in some data provided by Chinese drugmaker Sinopharm over its vaccine and the risk of serious side effects among certain patients who received the shot. According to a report from the WHO’s Strategic Advisory Group of Experts (SAGE), the panel of vaccine experts said they’re confident in the shot’s ability to prevent COVID-19 in adults. However, they warned that the company didn’t have enough data examining the shot in people with comorbidities or “health states that increase risk for severe COVID-19" following vaccination.
Anthony Fauci, the government’s top infectious diseases expert, said he believes the U.S. will be able to pick up its lagging vaccination rate by moving away from its “mass vaccination approach” and targeting local pharmacies and walk-in locations instead, CNN reports. Fauci’s comments come a day after the Biden administration outlined a new strategy amid a slow down in vaccinations nationwide. The U.S. now aims to have at least 70% of the population fully or partially vaccinated by July 4.
UPDATED: Tuesday, May 4 at 3:40 p.m.
The Biden administration, faced with a slowing vaccine rollout in some parts of the country, announced a shift in its strategy that will move doses away from mass vaccination centers and toward more local settings to boost the number of shots in arms, The New York Times reports. The federal government is directing pharmacies to offer walk-in vaccine appointments, creating more pop-up sites and shifting doses to more rural areas in an effort to vaccinate 70% of Americans, at least partially, by July 4.
CureVac chief Franz-Werner Haas said U.S. export controls for key vaccine supplies are hurting the company’s ability to predict short-term supplies for its jab, which is still under development, Reuters reports. Speaking with weekly Der Spiegel, Haas said the problem was due to the Defense Production Act, which has prevented the company from securing all the materials it needs from the U.S. to create its own stockpile.
Moderna will more than double the size of its manufacturing facility in Norwood, Massachusetts, which will support a 50% increase in production for the company’s mRNA COVID-19 vaccine at the site. The latest expansion is part of the reasoning behind Moderna’s accelerated vaccine supply forecasts. The company now estimates it will produce between 800 million to 1 billion doses this year, and up to 3 billion doses in 2022. Story
UPDATED: Tuesday, May 4 at 9:15 a.m.
The FDA is expected to authorize Pfizer’s COVID-19 vaccine, which it created alongside BioNTech, for adolescents 12 to 15 years old by early next week, The New York Times reports, citing federal officials. The agency’s endorsement would be an amendment to Pfizer’s existing emergency use authorization, and the CDC’s Advisory Committee for Immunization Practices (ACIP) would likely meet the following day to examine the clinical trial data.
Eli Lilly will supply India with an initial 400,000 tablets of its COVID-19 therapeutic baricitinib to help the country battle its raging outbreak. Lilly received an emergency authorization from Indian authorities on Monday for baricitinib paired with Gilead’s remdesivir in hospitalized patients requiring supplemental oxygen. The drugmaker said it’s also working with local Indian pharmaceutical companies to “execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India.” Baricitinib is approved in many places as the rheumatoid arthritis drug Olumiant.
BioNTech chief Ugur Sahin said the company, alongside its partner Pfizer, will be able to produce nearly 3 billion doses of its COVID-19 vaccine in 2021 thanks to ramped-up manufacturing. The pair had previously announced a target of 2.5 billion doses in 2021. Sahin said the German biotech is fortunately “not facing too many technical problems,” allowing it to meet its estimated delivery schedules.
Gilead Sciences filed a lawsuit against the Russian government last month for allowing one of its companies, Pharmasyntez, to manufacture and market Gilead’s COVID-19 treatment remdesivir, STAT reports. Russia’s Pharmasyntez is reportedly exploring the idea of sending the medicine to India. A Gilead spokesperson told STAT that it was disappointed in Russia’s decision to grant a compulsory license for remdesivir, which is marketed as Veklury, and that it “falls short” of Russian legal requirements for issuing a license.
UPDATED: Monday, May 3 at 3:30 p.m.
The European Medicines Agency (EMA) started an "accelerated assessment" of Pfizer and BioNTech’s COVID-19 vaccine, known as Comirnaty, for people aged 12 to 15. The EMA said its recommendation could come in June—unless additional information is needed—and would apply to all member states, pending the European Commission’s final consent.
Canada’s National Advisory Committee on Immunization (NACI), which makes recommendations for the use of vaccines, advised residents to weigh the risk of rare but serious blood clots reported among some Johnson & Johnson vaccine recipients and, if considered necessary, wait for a different shot. J&J’s vaccine, which has now been recommended for people 30 and older in Canada, is expected to be distributed across the country soon, CBC reports. The country had held its first shipments of the vaccine on Friday to verify its safety and quality.
Novavax told the European Union that it plans to deliver its vaccine to the bloc by the end of this year, a sign that a forthcoming supply contract could be announced as early as this week, Reuters reports, citing an EU official. Under the deal, Novavax would supply up to 200 million doses, providing the EU with booster shots to help contain the coronavirus and potentially guard against new variants, the official said. Story
AstraZeneca said it still plans to submit its vaccine for emergency authorization in the U.S. "in the coming weeks," even though the nation has an ample supply of doses from companies like Pfizer, Moderna and Johnson & Johnson. CEO Pascal Soriot defended the drugmaker when grilled by reporters about its recent stumbles, pointing to AZ's rollout across Europe and in India, where 300 million people are set to be inoculated by this summer. Story
UPDATED: Monday, May 3 at 9:00 a.m.
Pfizer CEO Albert Bourla said the drugmaker is discussing an “expedited approval pathway” with the Indian government to authorize its vaccine in the nation, which is facing a raging outbreak driven by variants of the virus. In a statement, Bourla said Pfizer would also donate $70 million worth of medicines to India, including steroids to reduce inflammation, anticoagulants and antibiotics.
The World Health Organization listed Moderna’s COVID-19 vaccine for emergency use for people ages 18 and older, a designation that will allow other countries to expedite their own approval process for the shot. Moderna’s vaccine is the fifth to receive emergency validation from the organization.
Moderna signed a supply deal with the global vaccine-sharing facility COVAX for up to 500 million doses of its mRNA shot with the option to procure an additional 466 million doses in 2022. The biotech said it would deliver an initial 34 million doses to the facility, which is backed by the World Health Organization, in the fourth quarter this year. Separately, Sweden donated 1 million AstraZeneca doses to COVAX, saying it plans to receive future shipments of vaccines from other companies, Reuters reports.
India and South Africa plan to review their proposal that would temporarily limit IP rights for drugmakers’ COVID-19 vaccines, Law360 reports. The countries said they will meet with other World Trade Organization members that have opposed the IP waiver, including the U.S. and EU, in an effort to find common ground.
UPDATED: Friday, April 30 at 3:20 p.m.
Pfizer will begin shipping doses of its mRNA vaccine made in the U.S. to Canada starting next week, Reuters reports, citing a senior official. Canada will become the second country outside the U.S. to receive doses of the drugmaker’s vaccine from its plant in Kalamazoo, Michigan, following Mexico. The country said it expects 2 million doses per week in May.
Pfizer and BioNTech announced that they've asked the European Medicines Agency to expand the use of their COVID-19 vaccine to people between the ages of 12 and 15. Currently, the pair's vaccine is authorized in Europe for those aged 16 and older. The drugmakers said the request was based on early data from a phase 3 trial that showed the shot was 100% effective against COVID-19 among the more than 2,200 trial participants within that age group.
Some European Union member countries, including France and Germany, are still pushing the bloc to strike a supply deal with French drugmaker Valneva for its COVID-19 vaccine, sources familiar with the matter tell Reuters. The news comes just over a week after Valneva said it would no longer prioritize supply talks with the EU but rather try to sign deals on a country-by-country basis. Previous discussions were held in January for up to 60 million doses of the company’s inactivated vaccine candidate.
Gilead Sciences reported $1.5 billion in sales for its COVID-19 antiviral remdesivir during the first quarter, which helped offset declines for its HIV and hepatitis C drugs. Executives at the company said they anticipate remdesivir "will have an important role to play" over the next couple of quarters. The drug's share of the U.S. market remains strong: Roughly half of hospitalized COVID-19 patients now receive the antiviral, which continues to “play a key role as a standard of care treatment” for patients globally, Gilead chief Daniel O’Day said. Story
Emergent BioSolutions CEO Robert Kramer said he takes “full responsibility” for the mishaps at the CDMO’s plant in Baltimore, which discarded millions of doses of Johnson & Johnson’s COVID-19 vaccine following a production mishap. Following the incident, Emergent announced a number of executive changes during the company’s earnings call. Mary Oates, who joined Emergent after 25 years at Pfizer, is now handling the contract manufacturer's response to the FDA’s list of concerns at the Baltimore Bayview plant. Story
UPDATED: Friday, April 30 at 11:32 a.m.
Emergent BioSolutions has made more than 115 million doses of Johnson & Johnson's single-dose COVID-19 vaccine, with some 60 million shots loaded into vials and ready for delivery, a person close to the matter told Bloomberg. The FDA has yet to clear those doses for release, however, and with a majority of American adults now vaccinated, new immunizations are slowing. Emergent has been under an intense spotlight after workers at its Baltimore plant mixed up ingredients for AstraZeneca and J&J's shots, ruining a batch that contained up to 15 million J&J doses.
Pfizer exported the first U.S.-made doses of its BioNTech-partnered vaccine this week, starting with deliveries to Mexico. The country has locked up 10 million Pfizer doses so far and said it expected to receive 2 million doses this week, though it's unclear how much of that shipment was made in the U.S., Reuters reports. As the U.S. makes headway on its vaccination drive, it's faced mounting pressure to re-distribute surplus shots to other countries.
Argentina met with AstraZeneca to talk about "possible difficulties" in its vaccine production there, Reuters reports, citing the country's health minister, Carla Vizzotti. During the meeting, Vizzotti also pressed AZ to lock down an estimated delivery schedule for the shots. Argentina last year struck a deal to receive roughly 22 million AZ doses, which it planned to produce locally and send to Mexico and the U.S. for finishing.
The U.K.'s drug regulator on Thursday said it had received another 41 reports of rare blood clots in people after they received AstraZeneca's COVID-19 vaccine. In an update this week, the Medicines and Healthcare products Regulatory Agency said it was aware of a total of 209 clots with low platelet counts linked to the shot, up from 168 cases reported last week. The EMA has said AZ should list clotting as a "very rare" side effect of the shot. Meanwhile, the U.K. has instructed people under the age of 30 to seek out an alternative vaccine.
Companies working on COVID-19 shots handed their executives some hefty pay packages in 2020, and Novavax, targeting an emergency nod for its protein-based vaccine candidate later this year, is no exception. President and CEO Stanley Erck reeled in roughly $48.09 million, while the company's R&D lead, Gregory Glenn, M.D., scored $24.92 million, according to the company's 2021 proxy statement.
UPDATED: Thursday, April 29 at 3:20 p.m.
The European Medicines Agency (EMA) said it will quickly review Eli Lilly's rheumatoid arthritis drug Olumiant, also known as baricitinib, for emergency use in hospitalized COVID-19 patients receiving oxygen. The regulator, which will review data from two randomized trials of hospitalized patients, told the news agency it expects a decision by July.
Israel’s Teva likely won’t strike a co-production deal with COVID-19 vaccine makers, although discussions are still ongoing, CEO Kare Schultz told Reuters. The company, which has the capacity to produce the shots in Israel and Europe, has offered to help, but “the key players that have actually been successful in developing the vaccines that have come to the market have found other partners or their own internal capacity,” Schultz said.
Moderna has increasingly heard from a mix of governments, public health officials and scientists that mRNA vaccines are the best way forward as variants of the coronavirus emerge, president Stephen Hoge, M.D., told Fierce Pharma in an interview. That's because as variants spread, drugmakers are forced to "update their vaccines really quickly," and mRNA offers the necessary speed for that response, Hoge said. Story
Total global spending on COVID-19 vaccines is projected to reach $157 billion through 2025, according to an annual forecast from IQVIA Institute for Human Data Science. This year alone, IQVIA projects spending of roughly $53 billion and $51 billion in 2022. The group sees a precipitous drop in total spending in 2023, to roughly $23 billion. Story
The European Union’s latest supply contracts for COVID-19 vaccines to be delivered in the next couple of years now have clear rules on what will happen if drugmakers fall short on their deliveries, Germany’s Health Minister Jens Spahn said. The EU took legal action against AstraZeneca this week for not adhering to its contract and providing a “reliable” plan to ensure timely deliveries.
UPDATED: Thursday, April 29 at 9:25 a.m.
Moderna said it’s ramping up its vaccine manufacturing and will boost its supply estimates as a result. The biotech said it’s now able to make up to 3 billion doses in 2022 and raised its bottom forecast this year from 700 million doses to 800 million. The company also announced that new data shows its vaccine can be safely stored at refrigerated temperatures for up to three months. Story
BioNTech’s CEO Ugur Sahin said he expects results by September from trials testing the company’s mRNA vaccine, developed alongside Pfizer, in babies as young as six months old, Reuters reports, citing an interview Sahin conducted German magazine Spiegel. Results from trials testing the vaccine in kids between the ages of five and 12 will be available in July, Sahin said.
Spanish pharmaceutical company Reig Jofre will begin manufacturing doses of Johnson & Johnson’s COVID-19 vaccine by the end of the second quarter. At the company’s new plant in Barcelona, Reig said it will be able to produce as many as 250 million doses annually.
French prosecutors have opened an involuntary manslaughter probe into three deaths among recipients of AstraZeneca’s COVID-19 vaccine, AFP reports. The prosecutors, who are taking over and combining three local cases, haven’t charged any entity or individual yet. According to the prosecutor's office, plaintiffs are trying to determine whether the vaccine caused the deaths of their loved ones.
Roche said it’s seeking a fast-tracked emergency authorization for its COVID-19 antibody cocktail, a combination of casirivimab with imdevimab, in India and can begin supplying the country with the drug immediately once given the OK, the Business Standard reports. Roche is also expanding production of its arthritis med Actemra, which has shown mixed results in treating COVID-19 patients.