Moderna says FDA refuses its application for new mRNA flu vaccine
[February 11, 2026]
By LAURAN NEERGAARD and MATTHEW PERRONE
WASHINGTON (AP) — The U.S. Food and Drug Administration is refusing to
consider Moderna’s application for a new flu vaccine made with Nobel
Prize-winning mRNA technology, the company announced Tuesday.
The news is 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.
Moderna received what’s called a “refusal-to-file” letter from the FDA
that objected to how it conducted a 40,000-person clinical trial
comparing its new vaccine to one of the standard flu shots used today.
That trial concluded the new vaccine was somewhat more effective in
adults 50 and older than that standard shot.
The letter from FDA vaccine director Dr. Vinay Prasad said the agency
doesn’t consider the application to contain an “adequate and
well-controlled trial” because it didn’t compare the new shot to “the
best-available standard of care in the United States at the time of the
study.” Prasad’s letter pointed to some advice FDA officials gave
Moderna in 2024, under the Biden administration, which Moderna didn’t
follow.
According to Moderna, that feedback said it was acceptable to use the
standard-dose flu shot the company had chosen — but that another brand
specifically recommended for seniors would be preferred for anyone 65
and older in the study. Still, Moderna said, the FDA did agree to let
the study proceed as originally planned.
The company said it also had shared with FDA additional data from a
separate trial comparing the new vaccine against a licensed high-dose
shot used for seniors.
The FDA “did not identify any safety or efficacy concerns with our
product” and “does not further our shared goal of enhancing America’s
leadership in developing innovative medicines,” Moderna CEO Stephane
Bancel said in a statement.
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A sign marks an entrance to a Moderna building in Cambridge,
Mass., May 18, 2020. (AP Photo/Bill Sikes, File)
 It’s rare that FDA refuses to file
an application, particularly for a new vaccine, which requires
companies and FDA staff to engage in months or years of discussions.
Moderna has requested an urgent meeting with FDA, and noted that it
has applied for the vaccine’s approval in Europe, Canada and
Australia.
In the last 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.
Kennedy announced last year that his department would cancel more
than $500 million in contracts and funding for the development of
vaccines using mRNA.
FDA for decades has allowed vaccine makers to quickly update their
annual flu shots to target the latest strains by showing that they
trigger an immune response in patients. That’s a far more efficient
approach than running long-term studies tracking whether patients
get the flu and how they fare. In an internal memo last year, Prasad
wrote that the streamlined method would no longer be permitted –
leading more than a dozen former FDA commissioners to pen an
editorial condemning the statements.
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