BioCentury
ARTICLE | Product Development

Pfizer-BioNTech COVID-19 vaccine endorsed at shambolic advisory committee meeting

December 11, 2020 2:23 AM UTC

Thursday’s FDA advisory committee meeting on the Pfizer-BioNTech COVID-19 vaccine could have been the shining culmination of a historic development program, but it failed to live up to its promise. If the meeting had been handled correctly, Dec. 10, 2020, would be remembered as the day a jury of scientists and physicians publicly weighed the evidence, declared that a vaccine safely and effectively protects individuals against COVID-19, and reassured Americans about the integrity and quality of the vaccine’s development and review.

Instead, as a result of poor meeting management, the public was left with no explanation for why four of the committee’s 22 voting members voted that the benefits of the BNT162b vaccine do not outweigh its risks for individuals 16 years of age and older, or why one member abstained. ...