Moderna says the FDA will consider its new flu shot after resolving a
public dispute
[February 19, 2026]
By LAURAN NEERGAARD
WASHINGTON (AP) — The Food and Drug Administration will consider whether
to approve Moderna’s new flu vaccine after all, resolving a dispute that
had blocked the company’s application for the first-of-its-kind shot.
Moderna announced the change Wednesday, about a week after revealing
that the FDA’s vaccine chief was refusing to review the new vaccine,
made with Nobel Prize-winning mRNA technology.
The dispute centered over a 40,000-person clinical trial that concluded
Moderna’s new vaccine was more effective in adults aged 50 and older
than one of the standard flu shots used today. In the FDA’s rare
“refusal to file” letter, vaccine director Dr. Vinay Prasad faulted the
trial for not including another brand specifically recommended for
people 65 and older.
Moderna publicly objected. It said that while the FDA had recommended
that approach, the agency ultimately agreed to the study's design — and
that the company shared additional comparison data from a separate trial
that used a high-dose shot for older people. Nor did the FDA identify
any safety concerns.
Still, Moderna said Wednesday that in a compromise, it is seeking full
approval for the vaccine’s use in adults 50 to 64 and accelerated
approval for those 65 and older, with an additional study once the shot
is on the market. Shares of Moderna Inc. closed up 6% Wednesday.
The FDA is targeting a decision on the application by Aug. 5, and
Moderna said it hoped to make the vaccine available later this year. It
also has applied for the vaccine’s approval in Europe, Canada and
Australia.
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A sign marks an entrance to a Moderna building in Cambridge, Mass.,
May 18, 2020. (AP Photo/Bill Sikes, File)
 “FDA will maintain its high
standards during review and potential licensure stages as it does
with all products,” HHS spokesman Andrew Nixon said.
The highly unusual public dispute was the latest sign of the FDA’s
heightened scrutiny of vaccines under Health Secretary Robert F.
Kennedy Jr., particularly those using mRNA technology, which he has
criticized before and after becoming the nation’s top health
official.
In the past year, FDA officials working under Kennedy have rolled
back recommendations around COVID-19 shots, added extra warnings to
the two leading COVID vaccines — which are made with mRNA technology
— and removed critics of the administration’s approach from an FDA
advisory panel.
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