FDA panel considers a first-of-its-kind flu vaccine using mRNA
technology
[June 18, 2026]
By LAURAN NEERGAARD and MATTHEW PERRONE
WASHINGTON (AP) — U.S. health advisers are debating a new kind of flu
vaccine Thursday, the first made with the same mRNA technology that was
key to ending the COVID-19 pandemic.
Moderna is seeking Food and Drug Administration approval of its new
shot, dubbed mFlusiva, as an option for people 50 and older. The FDA
advisory committee meeting is a step toward a final decision ahead of
the winter flu season.
Tens of thousands of Americans die from influenza every year, and older
adults are among the most vulnerable. There are various types of flu
vaccines already available in the U.S., including three specifically
recommended for people 65 and older. But vaccines made with the Nobel
Prize-winning mRNA technology are faster to manufacture than other types
— something experts say might help if the shape-shifting flu virus
mutates in a way that requires suddenly brewing new doses to match.
In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine
reduced flu cases by about 27% compared to those given another routinely
used vaccine brand. Ahead of the meeting, FDA published a favorable
review of that data and reported no safety concerns.
Moderna is seeking full approval for the vaccine’s use in the 50- to
64-year-old population — along with authorization for use in those 65
and older while it conducts additional testing.
Earlier this year, Moderna’s data was at the center of a highly unusual
public dispute as a then-top FDA official blocked the company’s
application for its first-of-its-kind shot.
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A sign marks an entrance to a Moderna building in Cambridge, Mass.,
May 18, 2020. (AP Photo/Bill Sikes, File)prnto
 The embattled vaccine chief at the
time, Dr. Vinay Prasad, said the company should have compared its
shot to a high-dose flu vaccine recommended for seniors rather than
a standard-dose brand. It was a sign of FDA’s heightened vaccine
scrutiny under Health Secretary Robert F. Kennedy Jr.
Moderna challenged that decision, noting that FDA staff had approved
that main study’s design and citing a separate, smaller study
comparing the mRNA shot with a high-dose vaccine for seniors. Days
after the spat, the FDA accepted Moderna’s application.
The expert panel also will assess that smaller study, which found
Moderna’s shot generated flu-fighting antibodies similarly to a
high-dose senior shot. The FDA’s initial review noted the new
vaccine lacks data on very frail older adults and those with weak
immune systems.
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