In this photo from Monday, Jan. 31, 2011, the Pfizer logo is displayed at the drug company's world headquarters in New York. Pfizer Inc. said Tuesday, Feb. 1, its fourth-quarter profit nearly quadrupled from a year ago when it was weighed down by charges as revenue rose 6 percent, thanks to the addition of products from fellow drugmaker Wyeth, acquired late in 2009.
Mark Lennihan / AP Photo
Mark Lennihan / AP Photo
In this photo from Monday, Jan. 31, 2011, the Pfizer logo is displayed at the drug company's world headquarters in New York. Pfizer Inc. said Tuesday, Feb. 1, its fourth-quarter profit nearly quadrupled from a year ago when it was weighed down by charges as revenue rose 6 percent, thanks to the addition of products from fellow drugmaker Wyeth, acquired late in 2009.
(Washington) — The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from Pfizer and its partner BioNTech ahead of a Thursday meeting of a group of independent experts that will advise the agency on whether to grant the vaccine emergency use authorization, or EUA.
The agency’s analysis finds “no specific safety concerns identified that would preclude issuance of an EUA.” Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing reactions at the site of injection, headaches and fatigue.
The analysis also affirms the previously stated vaccine effectiveness of 95%, assessed a week after two doses of vaccine. The vaccine doses are given 21 days apart.
The clinical data also suggest that the vaccine may be able to prevent COVID-19 after a single dose, though the FDA analysis says the available information doesn’t allow for a firm conclusion on that potential effect.
The vaccine authorization under consideration is “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
On Thursday the Vaccines and Related Biological Products Advisory Committee, an advisory group, will discuss the vaccine in an open public meeting.
The agency will ask the experts to assess if the available scientific evidence available supports the proposed emergency use of the vaccine. Specifically, the committee will be asked if the known and potential benefits of the vaccine outweigh its known and potential risks in people 16 and older.
The FDA will also ask the experts to weigh in on what additional studies should be done by the companies to further elucidate the safety and effectiveness of the vaccine after it is available under an EUA.
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