The safety and effectiveness of the nation’s first COVID-19 vaccine takes center stage Thursday as a critical committee vets and votes on whether to allow its general use by the American public.
Starting at 9 a.m. EST, the 17-member independent Vaccines and Related Biological Products Advisory Committee will review and discuss data from Pfizer and German startup BioNTech on their vaccine, called BNT162b2.
The daylong, live-streamed meeting comes a day after the nation set a new daily record for COVID-19 deaths, topping 3,000, according to Johns Hopkins University data.
Such meetings are always accessible to the public but Thursday’s is likely to be one of the most-watched ever.
The U.S. Food and Drug Administration published briefing documents in advance, and the public has an opportunity to submit questions. A one-hour public comment period also will be held during the meeting, said Norman Baylor,CEO of Biologics Consulting and the former director of FDA’s Office of Vaccines Research and Review.
“It’s a very transparent process,” he said.
That process will end around 5:15 p.m. when VRBPAC (pronounced verb-pack) is expected to vote to recommend the FDA authorize the Pfizer vaccine, which could come anytime after VRBPAC’s decision.
A vial of the COVID-19 candidate vaccine developed by BioNTech and Pfizer is displayed at the headquarters in Puurs, Belgium. (Photo: AP Images)
It’s not possible to predict with certainty what that vote will be, Baylor said. But judging from FDA’s overview of the vaccine’s safety and effectiveness published Tuesday and the fact that Pfizer and BioNTech have met all the criteria the FDA established for an authorized vaccine, the outlook is good.
“Based on that information, one could predict that if there are no untoward scenarios that come up, authorization could be relatively soon,” he said.
The companies are requesting an “emergency use authorization,” a more rapid overview just shy of a full vaccine approval. While they have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed and it’s not clear how long the vaccine will continue to be effective.
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If the committee recommends authorization, the FDA is expected to sign off on the vaccine, possibly as soon as Thursday night, setting the stage for the first doses to be distributed and administered across all 50 states.
The meeting begins with a presentation by the FDA on what an emergency use authorization is and how it works. Next there will bean update on the epidemiology of COVID-19 by the U.S. Centers for Disease Control and Prevention.
After that, the head of CDC’s National Center for Immunization and Respiratory Diseases, Dr. Nancy Messonnier, will discuss vaccine safety and effectiveness monitoring. A CDC staffer also will give an overview of distribution plans.
The next presentation will explain how placebo-controlled vaccine trials should be handled once a vaccine is available. Ideally, scientists want to continue testing new vaccines on people who are not vaccinated but that becomes ethically complicated once one is allowed for use.
After a lunch break, Pfizer/BioNTech will present their vaccine, BNT162b2. The FDA will follow with its findings.
Once the presentations are completed, the committee has two hours scheduled for discussion before it votes.
This is a developing story. Check back for updates.
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