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Posted on 06/18/2026 2:46:42 PM PDT by nickcarraway
Recommendation could pave the way for approval of the mRNA vaccine in adults 50 and up
An FDA advisory panel on Thursday unanimously endorsed the use of Moderna's trivalent flu vaccine candidate, which uses mRNA technology that's come under fire from the nation's top health official.
In two 9-0 votes, the Vaccines and Related Biological Products Advisory Committee said the benefits of the mRNA vaccine outweigh its risks for preventing the flu in adults 50 to 64 years and in those 65 and up.
"I do believe the data presented support that the benefits of the vaccine in both age groups outweighed the risks," said Flor Munoz-Rivas, MD, of Baylor College of Medicine in Houston.
Moderna's vaccine uses the mRNA platform it used to develop its lifesaving COVID shots, but under the leadership of Health Secretary Robert F. Kennedy Jr -- a prominent anti-vaccine activist before joining the federal government -- HHS cancelled $500 million in funding for mRNA vaccine research in favor of what he called "safer" platforms.
But panelists pointed to discrete benefits of mRNA vaccines.
"Having this technology available puts us in a position to be better prepared for emerging strains or pandemic strains in the future," said Munoz-Rivas.
Hayley Gans, MD, of Stanford Medicine Children's Health in California, called out the potential for lasting immune benefits beyond a single flu season.
"My biggest excitement about this particular vaccine is that it actually induces better T-cell responses," said Gans. "We've been struggling with the current flu vaccines because they don't maintain great immunity."
The supporting data did have limitations, noted panelist Adam Berger, PhD, of the NIH's Office of the Director, including the pivotal study's single-season length, limited efficacy data against influenza B, and the little data with the vaccine in immunocompromised or frail patients.
But Berger said the immunogenicity data presented were "very suggestive of potential efficacy clinically," and noted the vaccine's high efficacy compared to existing shots and the relatively reassuring safety data.
In the pivotal phase III Fluent randomized trial, the mRNA vaccine -- which targeted influenza A/H1N1, A/H3N2, and B/Victoria -- outperformed standard-dose flu shots, with a relative vaccine efficacy of 26.6% among all participants 50 and up and 27.4% for the 65-and-older subset.
People older than 65 accounted for most of the 2024-2025 season's hospitalizations and deaths, according to CDC estimates, with 57.4% of all flu hospitalizations and 70.6% of all flu deaths happening in that age cohort.
Following its dustup with the FDA, Moderna is pursuing a traditional approval in adults ages 50 to 64 and an accelerated approval for those 65 and older, with a postmarketing effectiveness study planned in that older group that will cover two flu seasons.
The agency in February initially rejected Moderna's application, with then-vaccine chief Vinay Prasad, MD, MPH, asserting the company lacked an "adequate and well-controlled trial" as it failed to compare the mRNA vaccine to "the best-available standard of care in the United States at the time of the study" -- a reference to the fact that the CDC recommends a high-dose vaccine for people 65 or older rather than the standard-dose shots used in the control arm.
The agency reversed itself after the drugmaker showed immune response data in the older subset at least matched the high-dose vaccines and committed to conducting a large and expensive randomized postmarketing study to compare effectiveness.
The planned post-approval study "will be important to answer some of the issues pertaining to efficacy and immunogenicity," said panelist Hana El Sahly, MD, also of Baylor College of Medicine.
Reactogenicity Messaging Will Need Work
While serious adverse event (AE) data with the mRNA vaccine were "reassuring," the greater rates of transient local (67.5% vs 32.1%) and systemic (58.0% vs 32.4%) AEs compared with the standard flu vaccines could be an issue for patients, according to El Sahly.
"While this is not a safety concern, this is an important acceptability concern, especially in light of vaccine alternatives," El Sahly said. Such reactions "have to be highlighted in our approach if we are to increase the vaccination coverage in our populations."
Having even a small percentage of people not going to work for 1 or 2 days because of AEs "is not trivial when we're talking about millions of individuals," she noted.
Retooling Shots in Mismatch Years?
All of the current FDA-licensed flu vaccines are manufactured using egg-based, cell-culture based, or recombinant production technologies. Those production processes can take 6 to 8 months to deliver vaccines after strain selection, a timeline that can slow reformulation during vaccine-strain mismatch seasons. In addition, most of the vaccines use egg-based manufacturing, which can lead to egg-adaptive mutations.
Adding mRNA technology to the manufacturing lineup could avoid adaptive mutations and improve response when vaccines don't match circulating flu strains. Moderna staff pointed to a 2- to 3-month turnaround from strain selection to production with its mRNA vaccines for COVID-19.
While the FDA is not required to follow the advice of its advisory committees in its approval decisions, it typically does.
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RFK Jr has completely checked out. He’s not calling the shots around there anymore.
Voluntarily mandatory, of course.
Why?
Now I definitely WON’T get a flu vaxxx.
I now foresee an argument with my doctor. I have been able to avoid mRNA-based shots, but they insist I get the flu shot.
It is your body. Tell them to GTH.
A.I. can make all the supposed “better” things about mRNA technology unnecessary. The only thing the old method lacked was the processing time needed to advance the vaccine made in the old method took too long. With A.I. that should no longer be an issue.
Kleon wrote: “RFK Jr has completely checked out. He’s not calling the shots around there anymore.”
Which is a great improvement.
“but they insist I get the flu shot.”
My PCP suggested that same thing yesterday. I laughed in her face. (She knew I would.)
“FDA Panel Endorses New Flu Shot That Uses Tech Dissed by RFK Jr.” I wonder how much bank a person could get for getting that shot?
Why is Moderna still a company? Why are not all its officers in jail or not breathing? They perpetrated a huge scam on the American people and caused immense damage with their bioweapon. Why are they not being tried and imprisoned or executed?
I can hardly wait to get an experimental MRNA vaccine from the same people who made the Moderna Covid vaccine!
How many boosters can I get to go with it?
I had a flu shot back in the ‘78s, then came down with a serious case of flu.
No shots since them and no flu.
My own MD told me I didn’t need a Covid shot either. Or any kind of vax. Healthy as can be, just turned 90 last week, which was a little shocking but now I’m used to it. Sure beats the alternative,
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