FDA Panel to Mull Covid Vaccine Strain Selection

FDA is announcing a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of the 2025-2026 formula for Covid-19 vaccines for use in the U.S.

The meeting should shed some light on how FDA intends to regulate Covid-19 vaccines amid growing concern that the agency, under HHS secretary Robert F. Kennedy Jr.’s leadership, may adopt a more skeptical approach on vaccine approvals. It will also likely be one of the first public appearances of former University of California, San Francisco professor and now CBER director Vinay Prasad, a vocal FDA-industry critic (see story).

Prasad has also been very critical of FDA’s response to the Covid-19 pandemic, including its authorization for boosters in children. He also has previously supported randomized placebo-controlled trials for the Covid vaccines to be used every year, a potential impediment FDA commissioner Marty Makary is contemplating (see story).