Reviewers at the Food and Drug Administration (FDA) are working overtime these days. On Friday, the agency issued a late-evening emergency use authorization for Pfizer (PFE 1.92%) and BioNTech's (BNTX 2.10%) coronavirus vaccine, BNT162b2. The EUA comes just a day after the agency's committee of outside experts recommend resoundingly that the agency issue the EUA.
The EUA allows Pfizer and BioNTech to begin distributing the vaccine in the U.S. for treatment of people 16 years and older. But an EUA only lasts as long as the pandemic emergency continues. Pfizer and BioNTech will eventually need to apply for a full approval, which will require additional safety data from the participants in the study. The EUA only required the biotechs to follow the participants for a median of two months after receiving the second dose.
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"Today's action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization," FDA Commissioner Stephen Hahn said in a statement.
The FDA reviewers aren't going to get any rest. Moderna's (MRNA 7.49%) coronavirus vaccine, mRNA-1273, is up next. The agency is scheduled to post its review of the data this Tuesday for another meeting of the advisory committee on Thursday. Considering how similar the data has been for the two vaccines, we'll presumably get another late-night EUA from the FDA next Friday.
