Today, the FDA's Vaccines and Related Biological Products Advisory Committee voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for Pfizer and BioNTech's COVID-19 mRNA vaccine (BNT162b2).
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the U.S. government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “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 U.S. in an effort to help combat this devastating pandemic.”
Pfizer's partner, Biopharmaceutical New Technologies (BioNTech), is a immunotherapy company that exploits a wide array of computational discovery and therapeutic drug platforms. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies.
The FDA will take the advisory committee's recommendation into consideration when it makes a final determination. The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. The Phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection.
More than 44,000 patients participated, most of whom received their second dose, in the ongoing Phase 3 clinical trial of the BNT162B2 based on BioNTech's patented mRNA technology.
All trial participants will continue to be monitored for an additional two years after their second dose. The ongoing Phase 3 clinical trial of BNT162b2 has enrolled more than 44,000 participants. The trial's primary endpoint is the prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization. The study also will explore prevention of infection by the virus that causes the disease.