A member of the FDA’s expert advisory committee who voted in favor of Pfizer and BioNTech’s coronavirus disease 2019 (COVID-19) vaccine told MSNBC that an Emergency Use Authorization (EUA) application for the vaccine could also be approved within the coming days.
Yesterday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 in support of granting an EUA for the COVID-19 mRNA vaccine (BNT162b2). Paul Offit, MD, told MSNBC that distribution of the primary vaccines to high priority populations within the us could begin early as Monday.
“My sense is what’s getting to happen today is that the [Centers for Disease Control and Prevention] goes to debate what they believe whether or not they might recommend this vaccine, but they can’t really recommend it until the FDA has approved it,” Offit told MSNBC in an interview. “So, then i feel they’re getting to discuss it today. The FDA is perhaps getting to approve it by Saturday then the CDC goes to vote on Sunday in order that by Monday the vaccine might be rolling out and being given to americans .”
The vaccine was previously granted a short lived authorization for emergency use against COVID-19 by the Medicines & Healthcare Products regulatory authority within the uk . This was the primary EUA for a COVID-19 vaccine to be issued following a world phase 3 trial testing the security and efficacy of the vaccine.
“We are looking forward to presenting our robust data package to the committee of vaccine experts for the United States government since we began our efforts to develop a completely unique COVID-19 vaccine earlier this year,” said Dr. Albert Bourla, Pfizer chairman and CEO, during a handout . “We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the able to bring this vaccine to people within the US in an attempt to assist combat this devastating pandemic.”