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7 clusters · 79 sources · 54 days · First seen · Last updated
Moderna mRNA flu vaccine mFlusiva US launch and scrutiny
Overview
By late September 2026, Moderna’s mFlusiva has become available at over 13,000 locations across the United States, including pharmacies such as CVS and Walgreens. The mRNA-based vaccine, which provides genetic instructions to trigger an immune response rather than using inactivated virus particles, offers a faster production timeline of two to three months compared to the six months required for conventional formulas.
While clinical trials suggest the formulation may offer superior protection against certain influenza A strains, data also indicates a higher frequency of mild-to-moderate systemic side effects, such as fever, fatigue, and muscle aches. No increase in serious adverse events has been reported in these findings. However, the vaccine has not yet been tested in immunocompromised populations.
The rollout continues to face scrutiny following a reanalysis of FDA clinical data published on the preprint server Zenodo. Researchers, including Dr. Peter McCullough and Nicolas Hulscher, have called for the vaccine's withdrawal, claiming it shows ‘abysmal efficacy’ in preventing hospitalizations and carries a higher risk of adverse events, including death, compared to non-mRNA standard-dose vaccines. They have urged Health and Human Services Secretary Robert F. Kennedy Jr. to halt distribution.
In Washington, availability of the vaccine varies as it is only included in some Medicare plans, with an estimated cost of approximately $171 for those without insurance. While some reports indicate the FDA has approved mFlusiva for adults aged 50 and older, other regional guidance recommends it specifically for individuals aged 65 and older, noting that approval for the 50 to 64 age range may still be pending in certain contexts.
Entities
mFLUSIVA · Moderna · U.S. Food and Drug Administration · Robert F. Kennedy Jr. · FDA
Claims
What the coverage asserts, and how many sources carry each claim.
Coverage disagrees
Sources make claims that cannot both be true. CLSTR reports the disagreement; it does not decide who is right.
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"The FDA approved Moderna's mRNA-based influenza vaccine, mFLUSIVA, for adults aged 50 and older."
vs
"mFLUSIVA was granted full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older."
One claim asserts the vaccine received full approval for ages 50-64 and accelerated approval for 65+, while the other asserts a single approval status for all adults aged 50 and older.
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"A reanalysis of FDA clinical data suggests the mRNA vaccine has low efficacy in preventing hospitalization and a higher risk of adverse events compared to standard vaccines."
vs
"In a study of over 40,000 participants, mFLUSIVA was approximately 26.6% to 27% more effective than standard-dose flu vaccines."
One claim asserts the vaccine is significantly more effective than standard vaccines, while the other asserts it has low efficacy in preventing hospitalization.
- [DISPUTED] The FDA approved Moderna's mRNA-based influenza vaccine, mFLUSIVA, for adults aged 50 and older.
- [DISPUTED] mFLUSIVA was granted full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older.
- [DISPUTED] In a study of over 40,000 participants, mFLUSIVA was approximately 26.6% to 27% more effective than standard-dose flu vaccines.
- [DISPUTED] A reanalysis of FDA clinical data suggests the mRNA vaccine has low efficacy in preventing hospitalization and a higher risk of adverse events compared to standard vaccines.
- [● 5 SOURCES] Moderna expects mFLUSIVA to be available for the 2026-2027 respiratory virus season.
- [● 5 SOURCES] As Health and Human Services Secretary, Robert F. Kennedy Jr. has criticized mRNA technology and previously canceled 22 federal mRNA vaccine development projects.
- [● 5 SOURCES] The FDA initially refused to review Moderna's application before reversing its decision following a dispute from the company.
- [● 2 SOURCES] Reported side effects included injection-site pain, fatigue, headache, muscle aches, nausea, and fever.
- [● 2 SOURCES] The mRNA platform allows for a production timeline of two to three months from strain selection, compared to six months for traditional egg-based vaccines.
- [○ 1 SOURCE] The Indonesian Pediatric Society recommends annual flu vaccinations for children starting at six months of age.
Timeline
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[HEALTH] 2 sourcesmFlusiva mRNA flu vaccine becomes available in Washington
Washington is introducing mFlusiva, a new mRNA-based flu vaccine recommended for individuals 65 and older. Coverage varies by insurance, and traditional shots remain an option.
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[HEALTH] 6 sourcesModerna mRNA flu vaccine mFlusiva released for older adults
Moderna’s mFlusiva, the first mRNA-based flu vaccine, is now available for U.S. adults aged 50 and older following FDA approval.
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[HEALTH] 6 sourcesModerna's mRNA flu vaccine mFlusiva arrives in U.S. pharmacies
Moderna’s mRNA flu vaccine, mFlusiva, is now available at U.S. pharmacies for adults 50+. While offering faster production, researchers have raised concerns regarding its efficacy and safety profile.
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[HEALTH] 3 sourcesModerna's mFLUSIVA receives FDA approval as first mRNA flu vaccine
The FDA has approved Moderna’s mFLUSIVA, the first mRNA-based flu vaccine, for adults aged 50 and older, showing higher efficacy in clinical trials for the 50–64 age group.
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[HEALTH] 3 sourcesFDA approves Moderna’s first mRNA flu vaccine for older adults
The FDA has approved Moderna’s mFlusiva, the first mRNA-based flu vaccine for adults 50 and older, offering a faster and potentially more effective response to mutating influenza strains.
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[HEALTH] 11 sourcesModerna's mFLUSIVA receives FDA approval as first mRNA flu vaccine
The FDA has approved Moderna's mFLUSIVA, the first mRNA-based seasonal flu vaccine for adults aged 50+, showing higher efficacy than traditional options.
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[HEALTH] 52 sourcesModerna's mFlusiva mRNA Flu Vaccine Approved by US FDA
The FDA approved Moderna’s mFlusiva, the first mRNA flu vaccine, for adults 50+. Full approval for ages 50‑64 (27% efficacy) and accelerated approval for 65+, with no major safety issues and limited supply for
Sources
2001online.com · 97rockonline.com · activistpost.com · alaraby.co.uk · am.com.mx · americanbazaaronline.com · anannya.com.bd · arabic.euronews.com · brasilemfolhas.com · ca.sports.yahoo.com · cbs58.com · chandpurtimes.com · cienciaysaludnatural.com · cubaheadlines.com · denesen.mk · directoriocubano.info · downtoearth.org.in · drug-dev.com · eenergetica.com.ar · egeszsegkalauz.hu · eldebate.com.ar · es.euronews.com · excelsior.com.mx · exitonoticias.com.bo · fr.euronews.com · health.clevelandclinic.org · infomoney.com.br · informationgovernance.com · issues.fr · kellybookblog.com · kmir.com · kpbs.org · krdo.com · ksfr.org · laopinion.com · lpm.org · lucianne.com · medcitynews.com · news-medical.net · newsday.com · newstalkkit.com · newstarget.com · nezavisen.mk · noticiasyprotagonistas.com · notiulti.com · nouvelles-du-monde.com · pharmexec.com · pplware.sapo.pt
This summary has been updated 6 times: see revision history