Report: Approval of Pfizer COVID-19 Vaccine Imminent, Distribution Could Begin Monday

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 may be approved in 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 first vaccines to high priority populations in the United States could begin early as Monday.

“My sense is what’s going to happen today is the [Centers for Disease Control and Prevention] is going to discuss what they think about whether or not they would 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 think they’re going to discuss it today. The FDA is probably going to approve it by Saturday and then the CDC is going to vote on Sunday so that by Monday the vaccine could be rolling out and being given to American citizens.”

The vaccine was previously granted a temporary authorization for emergency use against COVID-19 by the Medicines & Healthcare Products Regulatory Agency in the United Kingdom. This was the first EUA for a COVID-19 vaccine to be issued following an international phase 3 trial testing the safety and efficacy of the vaccine.

“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Dr. Albert Bourla, Pfizer chairman and CEO, in a press release. “We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”

A phase 3 trial demonstrated a vaccine efficacy rate of 95% (p<0.0001) in participants without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, which was the first primary objective, and also in participants with and without prior SARS-CoV-2 infection, which was the second. For both study objectives, the efficacy rate was measured from 7 days after the second dose of the vaccine.

For the first primary objective, the analysis was based on 170 cases of COVID-19. The observed efficacy in adults aged 65 years and over was more than 94%, with consistency in the efficacy rate across age, gender, race, and ethnicity demographics.

During the trial, BNT162b2 was found to be well tolerated by patients. Additionally, there have been no serious safety concerns reported to date by the Data Monitoring Committee.

Trial participants will continue to be monitored for an additional 2 years after the second dose to assess long-term protection and safety. The FDA will take the advisory committee’s recommendation into consideration when it makes a final determination.

“I would like to thank the FDA’s advisory committee for recognizing the critical role that our vaccine may play in helping to address this ongoing pandemic. Today’s positive discussion and vote reinforces the potential of our COVID-19 vaccine candidate in helping to protect people against this deadly and devastating disease,” said Ugur Sahin, CEO and co-founder of BioNTech, in a press release.

In a statement issued on Friday, the FDA said it will “rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”