FDA panel debates COVID vaccine recipe as questions swirl about fall shots

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter

WASHINGTON -- Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and winter — even as a new Trump administration policy has thrown into question who may be eligible for shots.

The Food and Drug Administration’s outside experts have met regularly since the launch of the first COVID-19 vaccines to discuss tweaking their recipes to stay ahead of the virus. Thursday’s meeting is the group's first since President Donald Trump took office.

But it comes just two days after FDA leaders upended the prior U.S. policy of recommending annual COVID-19 boosters for all Americans ages 6 months and older.

Instead, the FDA said routine approval of COVID-19 boosters will be limited to seniors and to younger people who are at high risk of severe infection. Manufacturers will need to do new studies to show whether seasonal shots still benefit healthy people younger than 65.

That has big implications for the fall vaccination campaign, with uncertainty over whether healthy people still could get a vaccine even if it's not recommended for them — or whether insurers will keep paying for the shots for everyone. Nor is it clear what the policy means for babies who have never been vaccinated.

“This is a mess,” said Michael Osterholm, a University of Minnesota infectious disease expert. “The one thing we don't want to do is put a barrier in place that prevents parents from getting their children vaccinated if they want to.”

The FDA deflected questions about the new policy at Thursday's meeting to decide whether the virus has mutated enough to warrant strain updates for shots from Pfizer, Moderna and Novavax. The committee’s recommendation is nonbinding guidance ahead of an agency decision.

Last fall’s recipe was tailored to omicron descendants on the JN.1 branch of the virus family tree. Novavax brewed shots targeting the parent JN.1 variant while Pfizer and Moderna opted for a subtype called KP.2.

With JN.1 descendants still dominating worldwide, Pfizer and Moderna representatives told panelists Thursday that their current vaccines remain effective, although switching to a newer subtype, LP.8.1, could provide even more protection. Novavax said sticking with the parent strain JN.1 — the company’s current vaccine formula — might be best.

The challenge for regulators is there's no way to predict how the virus will evolve by the time fall vaccinations begin.

The World Health Organization recently issued guidance that last year's version remained OK but that vaccine-makers could also choose an update. A representative for the organization told FDA panelists that current data on the COVID-19's continuing evolution might not yet warrant switching to a newer subtype. In contrast, the European Medicines Agency recently recommended targeting the newest subtype.

While demand for vaccinations has dropped, the Centers for Disease Control and Prevention estimates 30,000 to 50,000 adults have died from COVID-19 since October. The virus continues to cause “enormous burden” on the health care system, CDC’s Dr. Fiona Havers told panelists. Older adults count for most hospitalizations and deaths but COVID-19 also is “a major cause of pediatric hospitalization,” especially in children under 2 -- many of whom had no underlying medical problems before their infections.

The strain decision normally isn't the final word on recommendations about who should be vaccinated.

The CDC's own advisory panel meets in June to make recommendations about the fall shots. Among its options are keeping universal access or recommending vaccination for high-risk groups but still giving lower-risk people the choice in getting a shot.

CDC staffers presented real-world data Thursday showing that getting a booster last fall offered added protection even in people who had been infected and previously vaccinated. Company studies reached the same conclusion — including one by Moderna that compared medical records of about 900,000 people.

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