Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country met to discuss the first request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH.
The FDA authorized the approval of the Pfizer vaccine to for COVID-19.
The FDA is considered the "gold standard" regulator of medical products. The process that the FDA uses to review is respected worldwide because of a well-established history that the FDA has among the most rigorous – and accurate – review processes globally. Normally, the review process for vaccines studied in tens of thousands of people takes months.
Even though the process has been expedited in association with the review of this EUA, the FDA’s expert review staff has reviewed thousands of pages of technical information. These data include, but are not limited to clinical trial data, non-clinical data on the development of the vaccine in the lab, and manufacturing data on how the vaccine is made. FDA career officials have been reviewing the data and information ahead of the public advisory committee meeting to ensure a robust discussion with the independent experts.