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A federal advisory committee today unanimously voted to endorse Moderna’s mRNA flu vaccine — just months after rejecting the company’s application on the basis that Moderna had not performed an “adequate and well-controlled” clinical trial.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews scientific data on the safety and effectiveness of vaccines and other therapeutics on behalf of the U.S. Food and Drug Administration (FDA), voted 9-0 in dual votes to recommend approval of the vaccine for the 50-64 and 65-plus age groups.
Today’s votes took place after several hours of presentations based on the findings of Moderna’s Phase 4 clinical trial data for its mRNA-1010 vaccine. The trial compared the efficacy of mRNA-1010 to that of a conventional, non-mRNA flu vaccine.
Daniel O’Connor, founder and CEO of TrialSite News, told The Defender today’s favorable votes “may reflect the committee’s view that the benefit-risk profile is acceptable.” However, the vote “does not erase the fundamental concerns surrounding this application.”
“Significant questions remain about comparator selection, study design and whether the reported efficacy advantage represents a clinically meaningful improvement for patients or simply a statistical advantage within the framework of the trial,” O’Connor said.
According to an FDA briefing document prepared in advance of today’s meeting, “no major deficiencies were identified” with the vaccine for adults 50 and over. Citing the clinical trial data, the document states that the mRNA-1010 vaccine had a 26.6% relative efficacy rate in adults 50 and over, with similar rates for adults 65 and up.
The mRNA-1010 vaccine also showed a higher immune response than Sanofi’s Fluzone vaccine, the document noted. According to Fierce Biotech, these results met all of the FDA’s “pre-specified criteria for success” and bolstered Moderna’s application for approval.
Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said today’s vote shifts mRNA-1010 safety monitoring to after licensure.
“VRBPAC meetings proceed to the beat of the rubber stamp. The unanimous vote guarantees a lot of really good questions of harm will have to be answered in the post-marketing period, when that harm manifests in the population,” Jablonowski said.
Moderna seeks traditional approval for the mRNA-1010 vaccine for the 50-64 age group and accelerated approval for the 65-plus age group.
Fierce Biotech reported that the FDA uses VRBPAC meetings to “seek outside counsel on tough or high-profile regulatory decisions.”
The FDA will make an approval decision on mRNA-1010 by Aug. 5 — and while the agency is not bound to VRBPAC’s votes, it “often follows the opinions” of its advisory committees.
Moderna’s stock was up over 4% in trading immediately after the vote, and up 3.50% at the close of market.
mRNA vaccine had higher rate of adverse events than conventional flu shot
According to MedPage Today, all current flu vaccines are “manufactured using egg-based, cell-culture based, or recombinant production technologies” — a production process that could result in “egg-adaptive mutations” and which makes it slow to reformulate vaccines when they don’t match currently circulating flu strains.
In their briefing document, FDA scientists suggested that “high-volume manufacturing” of a flu vaccine “capable of rapid strain reformulation is … needed.”
However, the briefing document did identify some concerns with mRNA-1010. FDA scientists noted the higher rate of solicited adverse events among clinical trial participants who received mRNA-1010 — and the higher number of unspecified deaths and serious adverse events related to anemia or urinary tract infections.
The document also noted that “efficacy in immunocompromised individuals and very frail older adults has not been established” — which is “significant because these populations face the highest absolute risk of severe influenza-related complications and may respond differently to mRNA-based vaccine platforms.”
Several experts told The Defender that Moderna’s mRNA-1010 vaccine poses risks. “Throughout the study, solicited adverse events are almost, and in some cases more than, double that of the comparator,” Jablonowski said.
The briefing document acknowledged a higher rate of solicited adverse reactions for mRNA-1010 vaccine recipients than among the conventional flu vaccine recipients. According to the Association of Health Care Journalists, solicited adverse events are “those that the trial investigators specifically ask participants about because they are either expected or likely based on known reactions to other vaccines.”
Unsolicited (unexpected) adverse events, serious adverse events, adverse events of special interest and deaths “were balanced between treatment groups,” and “no cases of myocarditis or pericarditis were identified within 42 days postvaccination,” the document states.
Immunologist and biochemist Jessica Rose, Ph.D., said this period is too small to detect long-term risks. “There is no way to know what the long-term adverse events will encompass,” she said.
Dr. Angus Dalgleish, professor emeritus of oncology at City St. George’s, University of London, said, “There is no need for any specific flu vaccine.” He cited the high number of serious adverse events related to the mRNA COVID-19 vaccines.
“The case for mRNA gene therapies for any infectious disease can never be approved with current technology, given the totally unacceptable serious side effect risks,” Dalgleish said.
Rose agreed. She said that since mRNA-1010 is based on the same “flawed” platform as the COVID-19 shots, she anticipates “exactly the same problems as for the COVID shots, as per the millions of reported adverse events to pharmacovigilance databases.”
FDA glosses over safety concerns
These concerns are similar to those expressed when Moderna first filed its application for licensure in December 2025 and which contributed to the FDA declining to review the company’s application in February.
In a “refusal-to-file” letter signed by Dr. Vinay Prasad, then-director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccines, the agency cited Moderna’s failure to perform an “adequate and well-controlled” clinical trial and its failure to use the “best-available standard of care” during the trial process.
In February, STAT reported that Prasad overruled senior FDA vaccine reviewers, who were ready to review Moderna’s application. However, Andrew Nixon, a spokesperson for the U.S. Department of Health and Human Services, told STAT at the time that the claim was “categorically false.”
In response to Moderna’s claim that mRNA-1010 had a 26.6% higher relative efficacy rate than the existing Fluzone vaccine, former pharmaceutical research and development executive Sasha Latypova wrote on Substack that this is significantly lower than the 95% relative efficacy claimed for the mRNA COVID-19 vaccines during Phase 3 clinical trials.
Jablonowski told The Defender in February that the mRNA-1010 clinical trial data show that mRNA recipients had a 329% higher chance of sustaining a serious adverse event and a 278% higher chance of experiencing an unsolicited adverse event — referring to a condition that was not expected or previously known.
However, the FDA’s briefing document found that mRNA-1010’s safety profile was “acceptable for the intended population” and that there was no causal relationship between the vaccine and the unspecified deaths and cases of anemia and urinary tract infections identified during the clinical trial.
The document said these adverse events are “unlikely to represent a vaccine safety signal” and that the risk of rare adverse events should be tracked through post-licensure monitoring.
But according to Jablonowski, conventional flu vaccines have shown they have negative efficacy — placing the vaccinated at higher risk of flu than the unvaccinated. He said this makes any comparison between the candidate mRNA vaccine and existing vaccines invalid.
“If the current flu vaccines have negative efficacy, a placebo would be more efficacious. … In the 2024-2025 season, the Cleveland Clinic found a negative 27% efficacy,” Jablonowski said.
‘They’re promoting the platform’
The FDA’s decision to decline review of Moderna’s application led to an uproar within the pharmaceutical and public health spheres. Within two weeks, the FDA accepted the company’s application for licensure of mRNA-1010. Leadership shake-ups at the FDA soon followed.
Last month, Dr. Marty Makary resigned his FDA commissioner post, following rumors that he would be fired. In April, Dr. Vinay Prasad resigned from the Center for Biologics Evaluation and Research (CBER) — for the second time in less than a year. The FDA then fired Tracy Beth Høeg, M.D., Ph.D., the agency’s top drug regulator and a staunch advocate for vaccine safety.
Some experts suggested that political pressure — and corporate lobbying — contributed to the FDA’s about-face.
Blackstone, a New York-based investment firm, is the world’s largest alternative assets manager, with a portfolio exceeding $1 trillion. In 2024, the company launched an ongoing, $750 million investment in Moderna, explicitly to support the development of its mRNA flu shot.
Aside from its financial might, Blackstone is also closely connected to the Republican Party and the Trump administration, through significant donations from its executives and employees and through its ties with prominent lobbying firms linked to Republicans — and Big Pharma.
In turn, Blackstone’s CEO and co-founder, Stephen A. Schwarzman, has close ties to President Donald Trump and his administration, while members of Blackstone’s Life Sciences division have ties with several vaccine makers, including Pfizer.
In a post on X, Max Bayer, a science reporter with Endpoints News, noted that today’s meeting included the participation of a non-voting pharmaceutical industry representative and that “no waivers were issued for conflicts of interest.”
Working on a few other things so I won’t be live tweeting in abundance. But some notable bits:
– there’s still a non-voting industry rep on VRBPAC
– the committee is pretty much intact, much different than ACIP
– no waivers were issued for conflicts of interest— Max Bayer (@maxonwifi) June 18, 2026
Bayer also noted that unlike the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), which advises the agency on vaccine recommendations and which U.S. Health Secretary Robert F. Kennedy Jr. revamped before a federal court froze those changes, VRBPAC’s membership remains “pretty much intact.”
According to a February study, 557 clinical trials of mRNA therapeutic products are in progress, 507 of which involve vaccines, with Pfizer and Moderna leading the way in what analysts project will be a rapidly growing — and lucrative — market for mRNA products in the coming years.
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Rose suggested that these moves signal a desire on the part of the FDA to continue promoting mRNA vaccine technology.
“They’re promoting the platform,” Rose said. “People who acknowledge risk who oppose using an unsafe and ineffective platform are a problem for the industry players aligned with pushing this technology forward.”
Related articles in The Defender
- ‘Textbook Conflict of Interest’: Did Blackstone Pressure FDA to Reverse Course on Moderna mRNA Flu Vaccine?
- Moderna ‘Shocked’ After FDA Scuttles Review of New mRNA Flu Vaccine
- FDA Ousts Another Top Official: Who’s Behind the Shakeup — and Why?
- Moderna Pulls Application for FDA Approval of Flu-COVID Shot After FDA Calls for New Clinical Trials
- ‘Step in the Right Direction’: RFK Jr. Cancels $500 Million in mRNA Vaccine Contracts
- ‘Deeply Concerning’: This Year’s Flu Shots Led to 27% Higher Risk of Flu
