FDA to Discuss Pfizer’s Coronavirus Vaccine Authorization Request in December


The rollout of potential new coronavirus vaccines have a more concrete timeline following the FDA’s latest update regarding Pfizer‘s (NYSE:PFE) recent authorization request. Late on Friday afternoon, the FDA announced a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be held on Dec. 10. The group of independent experts will discuss Pfizer’s request for emergency use authorization (EUA) of BNT162b2, a coronavirus vaccine candidate the big pharmaceutical company is developing in partnership with BioNTech (NASDAQ:BNTX).

Meeting between physicians.

Image source: Getty Images.

Pfizer submitted its request to the FDA following positive results from a clinical trial with over 43,000 participants. At an interim analysis, there were 162 confirmed cases of COVID-19 among volunteers that received a placebo and just eight confirmed cases among patients that received the vaccine. Efficacy appears consistent regardless of volunteers’ age, gender, race, or ethnicity but with just eight positive cases there’s only so much that can be inferred. 

The VRBPAC is comprised of independent experts that will pick apart details in clinical trial data Pfizer submitted and whether it proves BNT162b2 is safe and effective enough to authorize for emergency usage. The FDA doesn’t have to follow the advice of its independent experts, but the agency and experts from the broader medical community usually land on the same page when it comes to interpreting clinical trial results. 

To date, the results we’ve seen from Pfizer have been from the company itself, but that will change roughly two days before the VRBPAC convenes. As is customary with independent advisory committee meetings, the FDA will release briefing documents to the public that highlight all of the agency’s concerns in an unfiltered format roughly 48 hours ahead of the meeting itself.

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