Why FDA may raise the bar for COVID vaccine authorizations
FDA announced Tuesday that it may limit its review of emergency use authorization requests for COVID-19 vaccines to those developed by sponsors that have been working closely with the agency.
Citing the need to prioritize EUA reviews, which unlike BLAs or NDAs are not supported by user fees, FDA said that for the remainder of the pandemic, it “may decline to review and process further EUA requests other than those for vaccines whose developers have engaged in an ongoing manner with the Agency during the development of their manufacturing process and clinical trials program.”
In a revised version of a guidance document on EUAs for COVID-19 vaccines, FDA also said it will decline to review and process EUA requests if it cannot verify “stringent evaluation of product quality, including a determination that the facilities producing the product meet appropriate standards; evaluation of the conduct of clinical trials; and assessment of trial data integrity.”
In addition to the three COVID-19 vaccines FDA has authorized, it has worked closely with three other companies that were supported by the Trump administration’s Operation Warp Speed: AstraZeneca plc (LSE:AZN; NASDAQ:AZN), Novavax Inc. (NASDAQ:NVAX), and Sanofi (Euronext:SAN; NASDAQ:SNY).
At least 21 other COVID-19 vaccines are under clinical development and at least 44 are preclinical development, according to BioCentury’s COVID-19 Resource Center.