FDA Says It Will Approve EUA for Pfizer’s COVID-19 Vaccine

Following a positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, FDA stated that it will rapidly work toward finalization and issuance of an emergency use authorization for the product. 

Additionally, the agency notified the CDC and Operation Warp Speed so they can execute their plans for timely vaccine distribution.

“Today’s meeting is an important step in the process – allowing outside scientific experts an opportunity to provide valuable advice and input for the agency to consider as part of its final review,” FDA Commissioner Stephen M. Hahn, MD, said in yesterday’s announcement.  

“Importantly, final decisions about whether to authorize a vaccine for emergency use will be made by FDA’s career officials in the Center for Biologics Evaluation and Research,” he continued. 

For FDA to issue an emergency use authorization to a vaccine, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. 

FDA stated that it expects an emergency use authorization submission to include all safety data from Phase 1 and 2 studies conducted with the vaccine. And Phase 3 data must include a median follow-up of at least two months after completion of vaccinations. 

At the end of November, Pfizer and BioNTech concluded a Phase 3 clinical trial after their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary endpoints.

Specifically, the candidate elicited a vaccine efficiency rate of 95 percent in participants without prior SARS-CoV-2 infection, as well as in patients with and without SARS-CoV-2 infection.

Researchers noted that all 170 cases were measured seven days after the second dose and efficacy rate was consistent across all age, gender, and race groups. They also saw 94 percent efficacy in adults over 65 years of age. 

There is an urgent need for medical countermeasures to diagnose, treat, and prevent COVID-19. But FDA must discuss the scientific evidence, safety, and effectiveness of a specific vaccine before granting emergency use. 

“In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process. But they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect,” Hahn said.

“The whole of the FDA—myself included—remains committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, Americans can have trust and confidence in receiving the vaccine for their families and themselves,” he concluded.