Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.

Rhea-AI Summary

Pfizer and BioNTech announced a favorable FDA advisory committee vote (17 to 4) supporting Emergency Use Authorization for their COVID-19 mRNA vaccine, BNT162b2. The decision is based on comprehensive Phase 3 efficacy and safety data, showing a 95% efficacy rate in study participants. If authorized, BNT162b2 will be the first COVID-19 vaccine available in the U.S. The FDA's final decision is pending, considering the advisory committee's recommendation.

Positive

• FDA advisory committee voted 17 to 4 in support of Emergency Use Authorization for BNT162b2.
• Phase 3 data indicates vaccine efficacy of 95% in participants without prior SARS-CoV-2 infection.

Negative

• None.

• FDA expected to make a decision on Emergency Use Authorization in the coming days
• Positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data
• If authorized, BNT162b2 would be the first COVID-19 vaccine available in the U.S.

NEW YORK and MAINZ, GERMANY, December 10, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today 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 this week in The New England Journal of Medicine. The Phase 3 data demonstrated 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. 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.

“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.”

“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.

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.

About the Phase 2/3 Study
The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina.  

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints are prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19.

Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 17 years of age will be gathered in the months ahead. Additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and

FAQ

What was the FDA advisory committee's vote regarding BNTX?

The FDA advisory committee voted 17 to 4 in favor of Emergency Use Authorization for BNTX's COVID-19 vaccine, BNT162b2.

What efficacy rate did the Phase 3 study of BNTX's vaccine show?

The Phase 3 study demonstrated a 95% efficacy rate for BNTX's COVID-19 vaccine, BNT162b2.

When is the FDA expected to make a decision on BNTX's vaccine?

The FDA is expected to make a decision on Emergency Use Authorization for BNTX's vaccine in the coming days.

What is the significance of BNT162b2 if authorized by the FDA?

If authorized, BNT162b2 would be the first COVID-19 vaccine available in the U.S.