Pfizer and BioNTech said that the FDA is expected to make a decision on Emergency Use Authorization in the coming days after giving a positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data, which would make BNT162b2 the first COVID-19 vaccine available in the U.S.
Pfizer and BioNTech said Friday that the U.S. Food and Drug Administration’s (FDA) 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). There is one member of the Committee whose vote is not included in the 17 to 4 vote decision.
VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced last month and published today in The New England Journal of Medicine, the companies said. As it has announced previously, the testing showed a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.
No serious safety concerns related to the vaccine
The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their 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.
Dr. Albert Bourla, Pfizer Chairman and CEO is pleased with the committee’s majority vote. In the press release, he was referred to as expressing readiness to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic, if the FDA issues an authorization.
Ugur Sahin, CEO, and Co-founder of BioNTech said that the positive discussion and vote reinforces the potential of our COVID-19 vaccine candidate in helping to protect people against this deadly and devastating disease.
FDA Advisory Committees provide non-binding recommendations, with the final decision on approval or authorization to be made by the FDA. Under an EUA, the FDA has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency when there are no adequate, approved, and available alternatives.