• Posted June 14, 2023

FDA Advisers Meet to Decide Next COVID Booster Shot

COVID-19 boosters may be offered this fall, but first scientists need to determine what strains to target and who should receive the shots.

Advisers to the U.S. Food and Drug Administration are slated to meet Thursday to discuss plans for fall, a decision with a deadline because drugmakers will need to have the time to manufacture the shots, NBC News reported.

The process is similar to deciding on an annual flu vaccine.

FDA scientists said redesigned boosters should target at least one variant of XBB, according to briefing documents published Monday.

XBB strains have been spreading since last fall and are related to an omicron subvariant.

“These data suggest that an updated strain composition of COVID-19 vaccines to more closely match currently circulating omicron sublineages is warranted for the 2023-2024 vaccination campaign,” the scientists wrote.

The World Health Organization and the European Medicines Agency have both said a booster should target an XBB subvariant.

As the virus has changed, vaccines have evolved, from a shot in December 2020 that targeted the original virus to FDA-approved shots last fall that targeted the original COVID strain as well as the omicron subvariants BA.4 and BA.5.

XBB 1.5 is the dominant strain now circulating, with 40% of new cases having this strain, according to the U.S. Centers for Disease Control and Prevention. About 18% of new cases have XBB.1.16 and 12.5% have XBB 1.9.1.

Current boosters provide some protection against XBB 1.5, but not as much as for BA.4 and BA.5.

The FDA's Advisory Committee on Immunization Practices, which will decide who should get a booster, will also meet next week to talk about this and other vaccines.

It would make sense if the COVID boosters were offered to everyone in the fall, Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children's Hospital, told NBC News.

“In my mind, it seems like a logical framework,” said Levy, a member of the FDA's advisory committee who will be involved in Thursday's meeting. “It will boost your antibody response and it probably affects your T cells as well, in a positive way.”

A new booster could be either bivalent, like last year's, targeting two strains or monovalent, targeting just that which is most prevalent.

More information

The World Health Organization has more on COVID-19.

SOURCE: NBC News, June 13, 2023