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Final steps in US review of COVID-19 vaccine

Public hearing to be held on Dec. 10 to to review Pfizer vaccine

December 8, 2020  by Associated Press

Pfizer’s COVID-19 vaccine is entering the final phase of review before the U.S. government decides whether to allow millions to get the shots.

The Food and Drug Administration posted a positive review of the Pfizer vaccine on Dec. 8 and will hold a public hearing on Dec. 10. Next week, it will do the same thing for Moderna’s coronavirus vaccine candidate.

A look at the process:

FDA REVIEW

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The agency’s scientific review is a key step — not just for the U.S. — but for countries around the world weighing whether to begin using a vaccine. Teams of FDA scientists scrutinize tens of thousands of pages of technical data provided by the companies, focusing on vaccine effectiveness, safety, side effects and the manufacturing process needed to ensure the quality and consistency of the doses.

Up until now, Pfizer and its partner BioNTech had only released minimal results about their vaccine’s safety and performance in company press releases. The details have yet to be reviewed and published in a medical journal.

“I’ve answered emails from three other continents today wanting to know what we’re doing because people trust us — they know we’re going to do a good job,” said Dr. Peter Marks, in an online event hosted by the American Medical Association

VACCINE EXPERT MEETING

Next, a group of about two dozen outside experts weighs in on the FDA’s findings and gives their own assessment. The panelists have expertise in vaccines, infectious diseases and medical statistics. The FDA is not required to follow their advice, though it usually does.

The daylong event also gives the agency a chance to pull back the curtain on its review process and try to assure the public that the vaccine was independently vetted.

FDA DECISION

Importantly, if the FDA gives the thumbs-up, it would still only allow limited use in certain high-risk groups because final-stage studies are not yet complete. That comes under FDA’s “emergency use authorization,” which is used to speed up the availability of medical products during a health crisis.