Medical expert committee to review BNT162b2 vaccine

The coronavirus (COVID-19) vaccine created by U.S. pharmaceutical company Pfizer and German drugmaker Bio’N’Tech is set for a final review for emergency use by the FDA. If this vaccine is approved, it could be the first COVID-19 vaccine available in the U.S. and could be available for use within days of approval.

COMING UP: At 9 a.m. today, the Vaccines and Related Biological Products Advisory Committee meeting is scheduled to begin.

The committee will discuss the EUA request for a #COVID19 vaccine from Pfizer/BioNTech.

Watch it live here. pic.twitter.com/xz2AXcBnGE

— U.S. FDA (@US_FDA) December 10, 2020

A 17-member independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) will start reviewing data of the BNT162b2 vaccine this morning with a live-stream of the meetings for the general public. The choice to host a live-stream event of the meeting for a transparent process that involves the general public that will end around 5:15 p.m. with an expected vote from the VRBPAC committee.

Though there will be an opportunity for a vote, this doesn’t necessarily mean the committee will come to a decision immediately but there are indications that BNT162b2 will be approved. On Tuesday, the FDA published an overview of BNT162b2’s effectiveness and safety for use with the vaccine meeting all the criteria required by the FDA.

The BNT162b2 vaccine was approved for emergency use for the UK and has delivered the first round of doses since approval last week. The only set-back of the BNT162b2 vaccine was a couple of adverse allergic reactions.

This is what the UK's Covid-19 vaccination cards will look like. Britain's healthcare providers are preparing to start administering the first doses of the vaccine tomorrow. https://t.co/gpbr9RpLFx

— CNN (@CNN) December 7, 2020

If the VRBPAC recommends authorization, the FDA is expected to approve the vaccine for emergency use as soon as Thursday night for distribution across all 50 states. The data shows evidence of the short-term safety and effectiveness of the BNT162b2 vaccine but the study process was compressed with limited data on how long the vaccine will continue to be effective.