Even though the alleged benefit for adults 65 and older was never proven.
The move comes after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in June that the “benefits” of Moderna’s experimental mRNA influenza vaccine “outweigh its risks.”
It also comes after President Trump selected a military-grade influenza pandemic architect, Erica Schwartz, to run the CDC.
Moderna expects to have the drug available for eligible populations in the U.S. for the 2026-2027 respiratory virus season.
Moderna’s own scientists confirmed in a May New England Journal of Medicine publication that mFLUSIVA triggers six times more severe reactions for less than 1% alleged absolute benefit.
The approval raises obvious safety and informed-consent questions about how long the body produces the purportedly encoded influenza proteins, what their long-term biological effects may be, and whether the product or its outputs could be shed from the original recipient onto others through exosomes or extracellular vesicles in excreted bodily fluids.
A 2021 Journal of Extracellular Vesicles study found that cells expressing a target protein can release extracellular vesicles that “carry” that protein, demonstrating that what is produced inside the body can be exported outside the cell in membrane-bound particles.
A separate 2023 Pharmaceutics review explains that exosomes are natural transport vesicles that carry proteins and nucleic acids throughout the body and are present in bodily fluids including blood, saliva, and other secretions—meaning they are not confined to the original cell or even the original location in the body.
You can contact the FDA here.
U.S. taxpayers funded the research behind mRNA-1010.
The FDA falls under Health and Human Services (HHS), which is run by Secretary Robert F. Kennedy Jr.
HHS is currently pursuing “day one” influenza pandemic vaccines, while the agency also funds experiments determining how to make influenza more pathogenic, investing American tax dollars in both the problem and the solution.
FDA Approved mFLUSIVA for Seniors Before Clinical Benefit Was Confirmed
While FDA granted traditional approval for adults 50 through 64, adults 65 and older received accelerated approval based on immune responses.
Moderna states: “Use in adults 65 years of age and older was granted accelerated approval.”
The company says the supporting trial enrolled 2,992 adults and compared mFLUSIVA’s immunogenicity against a high-dose inactivated influenza vaccine.
But clinical benefit has not yet been confirmed.
According to Moderna: “Confirmation of clinical benefit in this population will be assessed in a postmarketing clinical trial.”
Moderna repeats: “Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.”
In other words, FDA approved mFLUSIVA for Americans 65 and older before the clinical benefit required to maintain that approval has been confirmed.
FDA Used Different Evidence for Different Age Groups
The approval announcement reveals that FDA relied on two different evidentiary pathways.
For adults 50 through 64, approval was based on the 40,805-person Phase 3 trial measuring relative vaccine efficacy against a standard-dose influenza vaccine.
For adults 65 and older, accelerated approval was based on immune responses compared with a high-dose influenza vaccine.
Clinical benefit in the older population is to be confirmed after approval.
Bottom Line
FDA approved Moderna’s first seasonal mRNA influenza vaccine for adults 50 and older.
For adults 65 and older, the agency granted accelerated approval before clinical benefit was confirmed.
Moderna says that benefit will be tested after the product is already on the market.
The company’s own trial data also showed substantially more severe reactions for less than 1% alleged absolute benefit.
At the same time, the product instructs cells to produce influenza proteins inside the body, while the approval record cited here does not establish:
- how long that production continues;
- where the resulting proteins travel;
- whether they accumulate in organs or tissues;
- whether they are packaged into exosomes or other extracellular vesicles;
- how long those vesicles remain in circulation;
- whether they enter saliva, urine, breast milk, semen or other bodily fluids;
- or whether any biologically active product-derived material can pass from recipients to other people.
Published research already establishes that cells can export proteins through extracellular vesicles and that those vesicles circulate through bodily fluids.
That does not, by itself, prove person-to-person shedding from mFLUSIVA.
But it does establish the biological pathway FDA and Moderna would need to test before assuring the public that shedding cannot occur.
Instead, FDA approved the product for millions of older Americans—including a population for whom clinical benefit remains unconfirmed—without publicly resolving the duration, distribution, persistence, exosomal transport, or potential external release of what the injection causes the body to produce.
That is not merely a question of vaccine effectiveness.
It is a question of whether recipients, and people around them, have been given enough information to provide meaningful informed consent.
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