FDA panel is split on updates to COVID shots as questions loom for fall
vaccinations
[May 23, 2025]
By MATTHEW PERRONE and LAURAN NEERGAARD
WASHINGTON (AP) — Government advisers were split Thursday on whether
drugmakers need to update their COVID-19 vaccines for next season, a
decision overshadowed by confusion over a new Trump administration
policy that may limit which Americans can get the shots.
The Food and Drug Administration’s outside experts have met annually
since the launch of the first COVID-19 vaccines to discuss tweaking
their recipes to stay ahead of the virus. The challenge is trying to
gauge how the virus might evolve before fall vaccinations begin.
“We all want to make the perfect choice and that’s probably not
possible," FDA’s Jerry Weir told the panel of outside experts.
Some of the panelists voiced support for a switch to a newer coronavirus
subtype named LP.8.1. It's currently the dominant version and part of
the same family that circulated last year — known as the JN.1 branch of
the virus family tree.
“We cannot predict the future, but it seems like LP.8 would be more
likely to provide us better coverage," said Dr. Eric Rubin, a Harvard
infectious disease expert and editor of the New England Journal of
Medicine.
Other panelists noted that subtype is such a close relative that last
year's shots seem to offer cross-protection, at least for now but with
no guarantee there wouldn't be a different version circulating by the
time a vaccination campaign ramps up in the late summer or early fall.
Several advisers noted that people who want to get ahead of a summer
surge like the U.S. typically experiences could seek out the current
vaccines.
Hanging over the meeting was an FDA announcement earlier this week that
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
vaccine approvals will be limited to seniors and younger people with
underlying medical risks, pending new research for healthy adults and
children.
While that change has big implications for a fall vaccination campaign,
FDA leaders repeatedly sidestepped questions from advisers about whether
recommending an updated formula would trigger restrictions outlined in
the new policy.
“I don’t have an answer today,” said Weir. “I think a lot of this is
still under discussion.”
FDA staffers also wouldn't confirm whether the advisers would be given a
chance to meet about the new standards later.
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 FDA vaccine chief Dr. Vinay Prasad
said in opening the meeting that the agency wants “to give people a
little more time to digest” the new policy and is open to feedback
from its experts — although apparently not in Thursday’s public
forum.
Last fall’s recipe was tailored to the so-called
JN.1 family of omicron descendants. The advisory panel voted
unanimously that the family still is the right overall target, but
left the FDA to decide which specific subtype to choose.
Novavax brewed shots targeting the parent JN.1 variant and said
Thursday it was a good choice for this fall as well. Pfizer and
Moderna vaccines last year targeted a subtype called KP.2 and
company representatives told the FDA meeting that it showed
cross-protection, but that they favored an update.
The debate reflected an international difference of opinion on the
closely related virus strains. The World Health Organization
recently issued guidance that last year’s version remained OK but
that vaccine-makers could also choose an update, while the European
Medicines Agency preferred that newer LP.8.1 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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