Upcoming COVID-19 Vaccine Approval: What to Expect Soon
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Vaccine Authorization Timeline
Exciting developments surrounding coronavirus vaccines continue to emerge. On November 9, Pfizer announced promising results from its clinical trials, demonstrating that its vaccine effectively prevents COVID-19. This was soon followed by Moderna's positive findings on November 16, and AstraZeneca shared encouraging data just last week.
As the U.S. eagerly anticipates, the pressing question remains: When will Americans be able to receive their vaccines?
Pfizer has already sought emergency use authorization (EUA) from the Food and Drug Administration (FDA), with Moderna planning to submit its request imminently. Once the FDA approves these applications, some Americans may begin receiving their vaccinations within days.
Key Milestones for Vaccine Distribution
The timeline of critical events leading up to widespread vaccine distribution is as follows:
- November 30: Moderna is expected to submit its EUA application.
- December 7: The FDA will issue a Federal Register notice detailing its upcoming meeting to discuss Moderna's EUA.
- December 8: Briefing documents for the Pfizer vaccine meeting will be published by the FDA, which has already invited public commentary.
- December 10: An advisory committee of independent scientific experts will convene to review Pfizer’s EUA request. This meeting will be streamed online. Pfizer will present its data on safety and efficacy, followed by a Q&A session. The committee will then recommend whether to authorize the vaccine, and the FDA is likely to heed this advice, possibly authorizing it the same day or shortly thereafter.
- December 11-12: If Pfizer’s vaccine receives authorization, shots could commence within 24 to 48 hours. On December 1, an advisory committee from the CDC is anticipated to finalize guidelines for prioritizing vaccine recipients, with frontline healthcare workers likely at the forefront.
- December 17: An FDA advisory committee will evaluate Moderna's EUA request.
- December 21: Moderna's CEO stated that it could take 24 to 72 hours for the FDA advisers to make a decision, which means Moderna vaccines might not be available until four days post-meeting.
The video provides an update on the expected approval for new COVID-19 vaccines, highlighting key dates and processes involved.
Vaccine Distribution Projections
Moncef Slaoui, the chief advisor for Operation Warp Speed, has projected that up to 20 million Americans could receive their COVID-19 vaccinations by the end of 2020, with an additional 25 to 30 million people being vaccinated each month thereafter. This would enable the U.S. to potentially immunize around 70 to 80 million individuals—approximately a quarter of the population—by the end of February. By April, vaccines may also start reaching younger, healthier individuals.
Moderna's CEO recently indicated that by Memorial Day, every American who wishes to receive a vaccine should be able to do so. Furthermore, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, suggested that the general populace could have access to vaccinations by late spring or early summer.
Alternative Vaccine Candidates
The vaccination landscape could shift significantly depending on the authorization of additional vaccine candidates beyond those from Pfizer and Moderna. Operation Warp Speed has secured 100 million doses each from Pfizer and Moderna, with aspirations to distribute between 400 and 450 million doses by May.
Slaoui mentioned that "Plan A" includes distributing vaccines from AstraZeneca and Johnson & Johnson, which are also expected to report trial results soon. The U.S. has already purchased 100 million doses from both companies.
Should AstraZeneca and Johnson & Johnson’s trials yield successful results, they could receive authorization this winter. The remaining candidates backed by Operation Warp Speed are from Novavax and a partnership between Sanofi and GlaxoSmithKline, which are anticipated to provide pivotal data early in 2021.
In a recent NPR discussion, Fauci noted that additional vaccine candidates will be crucial to ensure sufficient supply for everyone in need.
This article has been updated with the latest information regarding Moderna’s EUA application, and was originally published on November 25.
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