FDA Approves Moderna's mRNA Flu Vaccine for Adults 50 and Older

The U.S. Food and Drug Administration approved Moderna's mRNA influenza vaccine, mFLUSIVA, for adults aged 50 and older, marking the first time the agency has licensed an mRNA vaccine for seasonal influenza, according to a company statement reported by The Epoch Times ^[1]. Moderna said the FDA granted traditional approval for adults aged 50 to 64 and accelerated approval for adults 65 and older.

The approval followed a unanimous 9-0 recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee ^[2]. The FDA had initially declined to review the application over concerns about trial design before reversing course after a high-priority meeting, according to a report by NaturalNews.com ^[3]. Moderna CEO Stéphane Bancel called the approval "our fourth approved product in the United States and the first mRNA-based flu vaccine" ^[4].

Approval Conditions and Trial Data

Moderna said the approval was based on a late-stage trial of more than 40,000 adults aged 50 and older that found the shot was 26.5 percent more effective than a licensed standard-dose flu vaccine. The company agreed to run an additional study and submit further data on adults 65 and older to demonstrate the vaccine's benefit in that age group, and Moderna also submitted separate late-stage data showing stronger antibody responses than Sanofi's high-dose flu vaccine in adults 65 and older after problems with the phase 3 trial methodology, according to The Epoch Times ^[1].

The vaccine uses mRNA technology intended to prompt the body to produce influenza antigens and trigger an immune response. Scientists said the approach could allow faster updates of the shot to match circulating strains ^[1]. In a 92-page review document, FDA reviewers said the trial's use of a standard-dose comparator limited interpretation of clinical benefit for adults 65 and older. "This limitation affects interpretation of the net clinical benefit in the 65 and older population and is a key issue for Advisory Committee deliberation," the reviewers wrote ^[1].

Adverse Events, FDA Review and Disclosures

The trial found higher rates of adverse events among mFLUSIVA recipients than among recipients of the comparator vaccine, with side effects including fatigue, headache, and muscle pain, according to FDA reviewers cited in The Epoch Times report. Serious adverse events occurred in 2.2 percent of mRNA vaccine recipients, with three events considered vaccine-related, compared with 1.9 percent in the comparator group ^[1].

A French peer-reviewed study published in 2022 concluded that mRNA COVID-19 shots increased the risk of myocarditis and pericarditis, particularly in adolescent and young adult males after a second dose, the report said ^[1]. The report also noted that multiple FDA advisory committee members who voted in favor of the flu vaccine had connections to Moderna, including El Sahly and Dr. Flor Munoz, who was a Moderna adviser from 2022 to 2024 ^[1].

Regulatory and Policy Context

Health Secretary Robert F. Kennedy Jr., who oversees the FDA, announced in August 2025 that the Department of Health and Human Services was winding down mRNA vaccine development under the Biomedical Advanced Research and Development Authority. Kennedy said funding would be redirected toward "safer, broader vaccine platforms that remain effective even as viruses mutate" ^[1]. In July 2026, HHS said Kennedy had signed determinations terminating the COVID-19 Emergency Use Authorization declarations for drugs, biological products, and medical devices ^[5].

Several FDA officials who had voiced opposition to mRNA vaccines have recently departed the agency, according to The Epoch Times ^[1]. An investigation by TrialSite News reported that regulators reviewing COVID-19 mRNA vaccines possessed data showing the products could travel throughout the body, even as the public was told the vaccines stayed "in the arm" and disappeared within a day or two ^[6]. Moderna withdrew its application for a COVID-flu combination shot last year after the FDA sought additional evidence, and European regulators approved the combination shot in April, the report said ^[1].

Market Outlook and Next Steps

mFLUSIVA will compete with flu vaccines from Sanofi, GSK, CSL Seqirus, and AstraZeneca. Conventional flu shots are largely egg-based and contain viral proteins, while the mRNA shot is designed to prompt cells to produce influenza antigens ^[1]. The spring strain-selection process can result in mismatches between targeted and circulating strains, an issue that the FDA and Moderna said the mRNA shot could address ^[1].

Flu vaccine effectiveness can range from 10 percent to 60 percent depending on the season, according to CDC estimates ^[1]. Analysts at Jefferies projected $750 million in U.S. sales from Moderna's flu shot and combination COVID-flu vaccine by 2030 ^[1]. Moderna has said the additional study in adults 65 and older will support the accelerated approval ^[1].

Conclusion

Karl Jablonowski, senior research scientist for Children's Health Defense, said after the advisory committee vote: "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" ^[2]. The statement reflects concerns that have followed mRNA products since the COVID-19 vaccines were introduced.

Robert F. Kennedy Jr.'s book The Real Anthony Fauci describes decades of pharmaceutical industry influence over public health policy ^[7]. Medical editors have also questioned the reliability of published research; Richard Horton, editor of The Lancet, wrote in 2015 that "possibly half the published literature may simply be untrue" ^[8].

References

1. Rachel Roberts. "Moderna's mRNA Flu Vaccine Approved By FDA". ZeroHedge. August 6, 2026.
2. "Breaking: Moderna's mRNA Flu Vaccine Gets Unanimous Thumbs-Up Despite Risks, Low Efficacy". ActivistPost. July 2, 2026.
3. Ramon Tomey. "FDA Agrees to Review Moderna's mRNA Flu Vaccine Following Initial Refusal". NaturalNews.com. February 20, 2026.
4. "FDA Approves New mRNA Jab". 100PercentFedUp. August 6, 2026.
5. Jon Fleetwood. "Kennedy Begins Year-Long Wind-Down Of COVID-19 Emergency Use Authorization Declarations". Modernity.news. July 1, 2026.
6. "When regulators knew more than they told: The untold story of mRNA vaccine biodistribution". NaturalNews.com. June 3, 2026.
7. Robert F Kennedy Jr. "The Real Anthony Fauci Bill Gates Big Pharma and the Global War on Democracy and Public Health".
8. Peter Breggin. "Canary In a Covid World How Propaganda and Censorship Changed Our World".

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