FDA panel recommends keeping COVID shots targeted to same strain as last year

Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons, maintaining guidance they gave last year.

The advisory committee convened Thursday for the first time under the Trump administration, meeting two days after FDA leadership unveiled new guidelines for COVID vaccine approvals. All nine members of the panel voted in favor of targeting shots to the JN.1 family of variants.

The FDA doesn’t have to follow the panel’s advice, but usually does.

The meeting featured introductory remarks from Vinay Prasad, who was recently made head of the FDA office that reviews vaccines and, together with Commissioner Martin Makary, wrote the new COVID framework. In it, they said the agency would continue to accept immune data for vaccine approvals in older adults and people with underlying medical conditions. But the FDA will now require placebo-controlled data to support clearances in healthy, younger adults, raising the bar for companies seeking broad OKs for new boosters they develop.

The new framework was not the focus of the meeting, however. “Ultimately, we still want to give people a little more time to digest the policy,” said Prasad. “We are asking for guidance to help the FDA decide what strains to select for COVID-19 vaccines going forward,” he added.

Committee members grappled with whether the current vaccine formulations needed to be updated at all. The World Health Organization and the European Medicines Agency both recently said monovalent shots targeting the JN.1 or KP.2 strains would continue to be appropriate. The EMA indicated it would prefer vaccine makers update shots to target a JN.1 subvariant known as LP.8.1, however.

That linage is currently the dominant strain in circulation in the U.S., although its spread may be leveling off. Some members weighed whether to get ahead of a new emerging variant, but noted it’s hard to predict how variants might evolve.

“From my perspective, I would say it’s maybe OK to stay with the current formulation for the summer, but we definitely should re-look at it,” said Archana Chatterjee, senior vice president for medical affairs at Rosalind Franklin University of Medicine and Science and a panel member.

Vaccine makers Pfizer, Moderna and Novavax all said they would be ready to deliver JN.1-targeting shot for the season, but Novavax noted timing would be close if LP.8.1 was chosen, which gave some advisers pause. (Novavax’s technology takes longer to adapt than the mRNA shots of Pfizer and Moderna.)

Henry Bernstein, a professor of pediatrics at Hofstra University School of Medicine and panel member, pressed FDA officials on how the new guidelines might affect vaccine access. “If we were to change strains, can we assume that age-specific licensure won’t change for any of these products?” he asked.

Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review, said he was unsure. “I don’t have an answer today. As I said at the start, I think a lot of this is still under discussion how this will be handled in the coming weeks and months.”

His boss, David Kaslow, said the agency couldn’t talk about specific company discussions, but added that the agency is “engaging with the manufacturers on this topic.”

Novavax just received a long-awaited FDA approval for its protein-based shot. But the clearance is limited to adults 65 years or over, or individuals between 12 and 64 years who are at high risk of severe disease — in keeping with the agency’s new guidance.

Separately, the FDA has asked Moderna and Pfizer to expand warning labels on their vaccines regarding heart in boys and young men, according to reporting from CBS News.

Advisers to the Centers for Disease Control and Prevention will meet next month and is expected to vote on updating its recommendations for who should receive boosters. In April, they discussed changes similar to the approval guidelines Prasad and Makary outlined Tuesday.

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