FDA steers updated vaccine to focus on dominant omicron subvariants

The FDA told vaccine manufacturers June 30 to focus on leading omicron subvariants BA.4 and BA.5, two days after an independent panel voted to recommend modified omicron-targeted vaccines. 

In the daylong meeting June 28, the independent panel didn't direct vaccine manufacturers on which omicron strains to target or whether to focus on a bivalent (containing omicron and a prototype) or a monovalent (containing omicron) vaccine. The FDA now points to the two subvariants and a bivalent vaccine containing a "BA.4/5 spike protein component."

"As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19," Peter Marks, MD, PhD, the director of the Center for Biologics Evaluation and Research, said in a statement. 

Subvariants BA.4 and BA.5 account for 52.3 percent of COVID-19 infections in the U.S., according to recent CDC estimates. 

 

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