Pfizer, BioNTech to Submit Emergency Authorization Request to FDA Friday for COVID-19 Vaccine

November 20, 2020

(ABC News) – Pfizer and partner BioNTech announced they will submit a request on Friday to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate. The submission, which is based on a vaccine efficacy rate of 95% demonstrated in the Phase 3 clinical study with no serious safety concerns to date, will potentially enable the use of the drug in high-risk populations in the United States by the middle to end of December, according to a joint press release.