Pfizer and BioNTech announced that they will be submitting an application for an Emergency Use Authorization for their candidate coronavirus vaccine to the US Food and Drug Administration today.
Earlier this week, the companies reported additional data from their late-stage trial showing that their vaccine, dubbed BNT162b2, had an efficacy rate of 95 percent. As CNBC previously noted, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said that a vaccine that is only 50 percent or 60 percent effective could be acceptable.
In their statement, Pfizer and BioNTech said that their EUA application could pave the way for their vaccine to be given to people in high-risk populations by mid-December.
As Vox notes, FDA's threshold for an EUA is lower than that of full approval, as treatments generally have to show "a likely benefit" for an EUA, rather than the "proven benefit" needed for approval. The Washington Post adds that FDA has required vaccine developers to submit at least two months of safety data on half their trial participants.
Vox further adds that FDA needs to be transparent in this process, as some critics say the agency may have damaged its reputation by giving EUAs to hydroxychloroquine and convalescent plasma.
According to the Post, Pfizer and BioNTech say they are ready to distribute their vaccine shortly after a regulatory decision.