FDA recommends updated target for fall Covid boosters

The FDA on Friday selected a specific Covid strain to be used in the next booster that should be ready for the public sometime in September.

The agency directed vaccine manufacturers that have authorized or approved Covid boosters to begin gearing up manufacturing of the selected strain, which accounts for about 40 percent of infections in the U.S. currently. The FDA also wants vaccine makers to continue testing the updated booster in trials to demonstrate that it will likely offer protection against severe disease and hospitalizations.

The FDA’s recommendation follows the guidance of its external advisory committee, which unanimously recommended Thursday that updated boosters target a single strain of the Omicron sublineage, which makes up the majority of cases worldwide. The committee agreed with the FDA staff assessment that focusing on the strain prevalent in the U.S. would likely offer adequate protection against other similar strains.

The manufacturers of the three Covid-19 vaccines available in the U.S. — Pfizer-BioNTech, Moderna and Novavax — have already begun preparing updated boosters that target the strain, called XBB.1.5. They’ll work on preparing their final submissions including updated safety data and data comparing immune responses from these boosters to previous Covid immunizations.

In the advisory committee meeting, Peter Marks, director of the Center for Biologics Evaluation and Research and the agency’s top vaccine regulator, said he hoped the next booster rollout could begin in September. He also said that if that can happen, the rollout will coincide with the availability of the newest flu vaccine — leading to more booster uptake among the public. Only 17 percent of eligible Americans have received a bivalent booster, which was most recently recommended by federal health agencies.

What’s next: Marks said the FDA will work closely with manufacturers as they submit data for their next boosters. He also said the agency will meet with the Centers for Disease Control and Prevention to discuss which populations should receive a booster shot.