Pfizer, BioNTech submit EUA request for COVID-19 vaccine

Nov. 20, 2020

Pfizer and BioNTech announced that they have submitted a request to the U.S. FDA for an Emergency Use Authorization (EUA) of their COVID-19 vaccine candidate.

While the FDA reviews the data, the drugmakers will present the safety and efficacy data to the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a public meeting and field questions from the committee. Pfizer expects this meeting will be scheduled for early December.

According to Pfizer, the EUA submission includes efficacy data from the total 170 confirmed cases of COVID-19 accrued in drugmaker's phase 3 trial, and safety data from a randomized subset of at least 8,000 participants 18 years and older. Data has also been collected from approximately 19,000 trial participants who have been followed for a median of two months following the second and final dose of the vaccine candidate as well as data on manufacturing processes.

If authorized by the FDA, the investigational vaccine could be used in high-risk populations in the U.S. by the end of December 2020. “If all goes well, I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if it all goes positively,” Ugur Sahin, the CEO of BioNTech told Reuters TV.

Read more on the Pfizer site