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FDA Analysis Of Pfizer COVID-19 Vaccine Finds It Effective And Safe

The authorization under consideration for the Pfizer/BioNTech vaccine would be for "individuals 16 years of age and older."
The authorization under consideration for the Pfizer/BioNTech vaccine would be for "individuals 16 years of age and older."

The Food and Drug Administration finds "no specific safety concerns" that would stand in the way of authorization of the vaccine for emergency use. Effectiveness is 95% after two doses.

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 an emergency use authorization.

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 the first dose — 82% effective — 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 whether the available scientific evidence supports the proposed emergency use of the vaccine. Specifically, the committee will be asked whether 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.

"If they vote to approve, which most of us believe they will get based on the data we've seen so far, then vaccinations could start quite shortly after that," Dr. Francis Collins, director of the National Institutes of Health, told Noel King on NPR's Morning Edition.

The advisory group makes a recommendation, but then it's up to the FDA's career scientists to approve the vaccine ultimately. Those scientists "have been poring over the details of how these trials have been turning out," Collins said.

The FDA scientists "look at every single record. It's the most detailed analysis you can imagine," he added.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

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