FDA vaccine panel gives thumbs up to Pfizer shot

Dec. 11, 2020

Pfizer and BioNTech have announced that the U.S. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine, BNT162b2.

In a brief FDA press statement, the agency said it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the CDC and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.

Pending an official FDA decision, the rollout Pfizer's vaccine could begin in the U.S. in a matter of days.

The advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted in favor of emergency authorization for people 16 and older. The "no" votes were reportedly from panel members with concerns about vaccinating people with severe allergies as well as those who felt there wasn't enough data to support inclusion of 16- and 17-year-old adolescents in the request for authorization.  Panel member Dr. Cody Meissner, a pediatric specialist, abstained from voting for that reason. Meissner told NPR that there were only 163 children aged 16 to 17 years old included in the trial, half of which received placebos.

Last week, the U.K. regulator, MHRA, authorized the Pfizer vaccine for emergency supply under Regulation 174.

The VRBPAC will meet in open session on Dec. 17 to discuss EUA for Moderna's vaccine in individuals 18 years and older.

Watch the archived Dec 10 meeting