FDA advisory panel takes up Pfizer-BioNTech COVID-19 vaccine

The Vaccines and Related Biological Products Advisory Committee is likely to recommend today that FDA approve a COVID-19 vaccine developed by Pfizer and BioNTech. The panel’s chairman, University of Michigan health researcher Arnold Monto, cited research demonstrating that the vaccine is 95% effective and safe to use, with few adverse events (AEs). Importantly, company and agency analyses released this week indicate the vaccine works well across different age and ethnic groups and in spite of underlying conditions. Severe AEs were rare, although many patients experienced headache, fatigue, and other mild reactions soon after receiving the injections. If the 23-member committee votes in favor of FDA approval and the agency follows the recommendation, convincing Americans to get vaccinated could still be a challenge. FDA officials hope that by opening today’s meeting to the public and live-streaming it, they can convey the care that has been taken to ensure the vaccine is safe and has not been rushed through the review process for political reasons. The advisory committee’s meeting will be public and live-streamed.