Sarah Silbiger
The FDA announced Friday that an independent group of its experts would meet in January to discuss how to revise the composition of currently available COVID-19 vaccines and boosters in response to a fast-changing virus.
The decision comes as studies indicate that the BA.4 and BA.5-adjusted booster shots developed by Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) generate a weaker immune response to fast-emerging COVID subvariants such as BQ.1.1.
The meeting scheduled for Jan. 26 will focus on how to modify the primary doses of the currently available COVID -19 vaccines and whether to change the composition and dosing of updated booster shots.
The FDA has so far greenlighted COVID-19 vaccines developed by Pfizer (PFE)/BioNTech (BNTX), Moderna (MRNA), Johnson & Johnson (JNJ), and Novavax (NVAX).
“Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” the FDA said.
According to the latest data from the Centers for Disease Control and Prevention (CDC), BQ.1.1 looks to become the dominant COVID strain in the U.S., making up an estimated ~38% of cases compared to 10% of BA.5 cases.
The meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will include presentations from vaccine manufacturers, and representatives from the CDC as well as the National Institutes of Health (NIH) will also join the discussion.
In June, the FDA advised vaccine makers to update their booster shots for BA.4 and BA.5 subvariants of Omicron ahead of a booster program in fall 2022.
