FDA Says Pfizer Vaccine Meets Success Criteria, No Safety Concerns That Would Block Approval

A patient receiving Pfizer's COVID-19 vaccine at the University of Maryland School of Medicine in Baltimore, Md., on May 4, 2020. Courtesy of University of Maryland School of Medicine via AP

The Food and Drug Administration (FDA) released an analysis of the Pfizer-BioNTech COVID-19 vaccine on Tuesday, concluding it is highly effective and finding “no specific safety concerns” that would prevent the agency from authorizing emergency use of the product.

The FDA’s analysis (pdf) was issued ahead of a Thursday meeting with a panel of independent medical advisors that will discuss whether scientific evidence supports the view that the vaccine, called BNT162b2, is effective in preventing COVID-19 in people aged 16 and older, and if the known benefits outweigh potential risks.