Pfizer is Planning to File an EUA with FDA for its COVID-19 Vaccine Within Days

Pfizer and Biontech announced this morning their investigational vaccine, BNT162b2, is 95% effective against COVID-19, beginning 28 days after the first dose.

The 2 companies jointly involved in the vaccine confirmed 170 cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group. After conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.

With the safety and efficacy endpoints met, the companies are planning to file a request for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) within days.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Pfizer Chairman and CEO Albert Bourla, PhD, said. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”