Yesterday, Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has “approved mFLUSIVA® (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older.”
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.
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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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I get it! Social Security is bankrupt by 2033 unless they reduce usage. Since a large portion of the Medicare costs are incurred in the last six months of a persons life, then lets speed up the process!
A win-win not only for SS, but also making Medicare less costly. Bravo Trump! You know the numbers! I wrote the following on some other sites in response to the money windfall for Moderna. I am repeating it here!
Is the flu for real? Absolutely! The virus expresses itself when the immune system is deficient in viability. When does it peak? In the temperate climates when sun exposure is at it's lowest. The average person's store of Vitamin D which is created by sunshine interacting with the cholesterol in the skin is deficient because of life style issues and at it's lowest in February. Thirty years ago, only about 10% of the US population bought into getting a flu shot to supposedly prevent the flu. In 2018, 50% of the population submitted to a flu shot and flu deaths were at a all time high. Fauci claimed 80,000 died and then backed off the number because it was an indictment that the FLU shots do not work!
Solution. Find a new form called mRNA. Create a viral like compound that bypasses the immune systems sentinel systems and reprograms cellular function to create a foreign protein that in turn will some how stimulate the immune system to attack the virus. So, what could go wrong with this approach? Covid mRNA demonstrated lot's! Deaths and injuries, some permanent from the Covid mRNA shot are still in the deniable stage by the medicine men that see profits rather than good health out comes.
If you understand statistical analysis and the gross deficiencies in the medical data systems, it is easily determined on a projection basis that at a minimum at least 600,000 Americans died from the mRNA injection immediately, and that 4 or 5 times have been injured, some permanently In 1979, I got the flu and was laid low. My immune system was deficient. In 2007, I got my first flu shot and acquired the flu and dispatched it in 6 hours with 2 Aspirin, 2 Vitamin C and 2 NAC. In addition my blood value of D was superior and above 50 ng's.
There is another aspect of the flu scenario that is not recognized in the medical community that may be contributing to the seasonal explosion of flu cases. Chronic consumption of medication containing acetaminophen. Overdosing through chronic consumption of pain pills containing acetaminophen will express the same symptoms that are express by the flu virus. In turn, if there is a mis diagnosis, the physician will recommended MORE acetaminophen to treat the problem. Results can be disastrous and include death, or liver transplants.
So, clearly my answer is NO! My body is my temple and you will not violate it! What needs to be recognized by the general public is that our "healthcare system" in the US which is bloated financially and clearly expressed in a chart on the Whitehouse website is in reality a sick care system masquerading as a healthcare system.
Question: Has anyone meet a person living on the tropical island that is a resident that got the flu? The gate keepers at the FDA need to be vetted for competency and their ability to understand their role is to protect the health of the American public and not the health of the corporate pocket book.
Sad day for the US.