A committee of physicians, academics, disease experts and biostatisticians told the FDA that more data should be collected before a COVID-19 vaccine is approved. The group convened for a full-day meeting Oct. 22 to discuss the COVID-19 vaccine approval process. The Vaccines and Related Biological Products Advisory Committee will advise the FDA in how it should approve a future COVID-19 vaccine.
Four takeaways from the meeting:
- Some committee members said that the FDA’s current requirement that data be collected for two months after a patient receives their second dose of the vaccine isn’t enough, The New York Times reported. They urged the FDA to require vaccine developers to collect longer-term data to evaluate potential risks and to determine if immunity to the virus wanes after a few months or if rare side effects emerge.
- Several committee members argued against ending clinical trials if a vaccine becomes available through emergency use authorization. Pfizer has said it would be ethically obligated to give the vaccine to people in its clinical trial instead of a placebo if a vaccine were authorized, Times reported. But the experts say ending clinical trials after an emergency use authorization wouldn’t allow for researchers to gain enough data on the vaccines to ensure they’re safe in the long term. The FDA has said it doesn’t consider emergency use authorization to be grounds for stopping a clinical trial, The Hill reported.
- Some members, including Marion Gruber, PhD, the director of the Office of Vaccines Research and Review, suggested making the vaccine initially available under expanded access instead of an emergency use authorization. Expanded access, which is typically used to give experimental drugs to critically ill patients, would allow clinical trials to continue while people who are high risk could be vaccinated, the Times reported.
“We are concerned about the risk that use of a vaccine under an EUA would interfere with long-term assessment of safety and efficacy in ongoing trials and potentially even jeopardize product approval. And not only the first vaccine, but maybe even follow-on vaccines,” Dr. Gruber said, according to STAT.
- A vaccine maker that receives an emergency use authorization might not be able to generate enough additional data to ever successfully gain full approval from the FDA if clinical trials are stopped, said Arnold Monto, MD, chair of the committee and professor of epidemiology and global public health at the University of Michigan in Ann Arbor. An emergency use authorization could also mean the participants in a clinical trial may choose to pull out of the trial to make sure they get the vaccine, STAT reported.
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