Pfizer's COVID-19 Vaccine Set for Final Review, Could Become First Authorized By FDA for US Use As Early As Thursday
Dec 10, 2020
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The safety and effectiveness of the nation's first COVID-19 vaccine is taking center stage Thursday as a critical committee spends the day vetting and then voting on whether to recommend its general use by the American public.
The 17-member independent Vaccines and Related Biological Products Advisory Committee is reviewing and discussing 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.
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.
Monitoring for post-vaccination problems
Watching for any adverse reactions among people who’ve gotten the vaccine is a major concern. During the morning portion of the meeting, the U.S. Centers for Disease Control and Prevention Dr. Nancy Messonnier outlined the multiple systems that will be monitoring possible problems.
New to the vaccine world is V-SAFE, a smartphone-based after-vaccination health checker that people who get COVID-19 vaccine can sign up for if they choose.
It will send text messages and web surveys to those who do, and feed information about any health problems directly back to CDC. Anyone who reports a medically significant adverse event will get a telephone call from a CDC staffer to find out more.
Another monitoring system is VAERS, the Vaccine Adverse Event Reporting System. This is a joint CDC and FDA system established in 1990. It collects reports about adverse events from vaccines from health care professionals, vaccine manufacturers and the public.
Any adverse events that are unexpected, appear to happen more often than expected or have unusual patterns are followed up with specific studies.
The Department of Defense also has its own system for following adverse events among its personnel, as does the Indian Health Service.
Finally, there's the Vaccine Safety Datalink, a network of nine large integrated health care organizations across the United States that conduct active surveillance and research on vaccine side effects. Because these health systems have access to their members’ medical records, they can often see patterns that might not immediately be visible to other networks.