FDA Panel Recommends a Covid Vaccine Aimed at Only the XBB Variant

Pfizer, Moderna, and Novavax have emphasized the importance of sufficient time to produce tens of millions of vaccine doses, which are expected to be ready for distribution in the upcoming autumn.

“I think that’s what today’s discussion is about — how to best to come up with what goes into people’s arms to offer the best protection during a period when we think we’ll have waning immunity,” said Dr. Peter Marks, the F.D.A.’s vaccine chief. He added that the winter may also bring “further evolution of the virus.”

Since the beginning of the pandemic, 6.2 million hospitalizations and 1.1 million deaths have been attributed to the virus in the United States, according to data presented by Natalie Thornburg, a vaccine expert at the Centers for Disease Control and Prevention.

She said the picture had improved this year, but those who remain vulnerable include the unvaccinated, people who are immunocompromised and those who have diabetes or chronic kidney, lung, cardiovascular or neurologic diseases. People 65 and older are also at risk, and that rises with age.

The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. About 20 percent of adults, or about 53 million, in the United States got the booster shot, with the rates higher among older adults.

Moving ahead with a shot targeted at only an XBB variant means that newborns and people with compromised immune systems may not have immunity against the earliest coronavirus variants. That should not be a problem, according to a briefing given by a World Health Organization official, who said those variants were no longer in circulation.

The F.D.A. is anticipated to issue an official recommendation to vaccine manufacturers in the near future. Manufacturers will be required to conduct studies on the new vaccine formulations and provide data to the agency. If approvals are granted, the C.D.C. will provide guidance to healthcare providers regarding the recommended age groups for vaccination.

According to an F.D.A. spokesperson, it is expected that an updated vaccine will be accessible by late September, assuming the data supports the safety and effectiveness of the vaccines.

It is currently unclear whether the vaccine manufacturers or the F.D.A. will assess the potential effects of administering multiple vaccines in the fall, including those for the flu and respiratory syncytial virus (R.S.V.), which are expected to be available for pregnant individuals and older adults. Advisory panels have also endorsed the use of an R.S.V. antibody shot for protecting infants.

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