Pfizer and BioNTech Request Emergency FDA Authorization for 95% Effective COVID-19 Vaccine
Pfizer and BioNTech officially request emergency use authorization from the FDA for their highly effective COVID-19 vaccine. The companies plan to distribute millions of doses globally within hours of receiving approval.
Pfizer and BioNTech submit a request to the U.S. Food and Drug Administration for Emergency Use Authorization of their COVID-19 vaccine candidate, BNT162b2. This submission potentially allows high-risk populations in the U.S. to receive the vaccine by the middle to end of December. The companies also initiate rolling submissions across the globe, including in Europe, Canada, and the United Kingdom.
The authorization request relies on clinical data showing a 95% efficacy rate in Phase 3 trials. Researchers observe no serious safety concerns among the approximately 38,000 trial participants who receive the vaccine. The study includes a diverse group of participants, with 42% of global enrollees representing various racial and ethnic backgrounds and 41% falling into the 56 to 85 age bracket.
Manufacturing and distribution plans move forward rapidly alongside the regulatory submission. Pfizer and BioNTech project the production of up to 50 million vaccine doses globally by the end of 2020, scaling up to 1.3 billion doses by the end of 2021. The pharmaceutical partners confirm they stand ready to distribute the vaccine within hours after receiving the necessary regulatory authorization.