I praise Prasad for leaving your clowns…now I praise him…good for him!
Dr. Vliet’s Health Tip: The mRNA Flu Shot: From Refusal to Rubber Stamp… & Real Risks You Don’t Need!
© by Elizabeth Lee Vliet MD and Kathy Kresnik
After all the devastating damage from the experimental mRNA COVID shots, I was actually shocked to see the FDA’s sudden reversal and now approval of Moderna’s mRNA flu shot, mFlusiva, the first-ever mRNA influenza vaccine in the United States, based on extremely limited safety and effectiveness data. We have outcome studies from medical databases around the world confirming the increased deaths and extensive multi-organ system damage from the mRNA COVID shots, so I am appalled that mRNA strikes again with this latest FDA action to approve the mRNA flu shot. It’s just one more mRNA gene therapy experiment being deceptively foisted on the public as a “vaccine.” Even traditional flu shots are using a highly profitable, minimally beneficial vaccine for an illness that is readily treatable with existing Rx medicines, natural medicines and supplements that boost our natural immune function! So why are we being exposed to another round of new risks from an mRNA shot for influenza?
To make matters worse, in my view, this new mRNA flu shot is authorized for adults 50 and older, with full approval for ages 50–64 and “accelerated approval” for those 65 and up. Elderly people were hardest hit with the complications of the mRNA gene therapy COVID shots! They are also the ones hit hardest with the ongoing damage from those original COVID shots AND the group most likely to be heavily pressured to take every shot and every booster that comes out. So why are the FDA and “Big Medicine/Big Pharma” and “Public Health” bureaucrats pushing another risky mRNA shot for the elderly?
A bigger question I think we should be asking is why do we need ANOTHER mRNA experiment on the American people at all?
Of course, once again, we will see mainstream media and the usual “vaccines fix everything” crowd celebrating this latest mRNA “vaccine” as a technological milestone, emphasizing faster manufacturing, potentially better strain matching, and a reported 27% higher “relative” efficacy compared with a standard-dose flu vaccine. Their marketing message is simple: this is a new, advanced option to protect vulnerable older adults before flu season.
In this Health Tip, I want to help you look past the headlines and marketing language, and consider the real risks you are not being told. I want to help you think about the serious questions you need to look into on your own to help you make informed decisions before you just jump on the bandwagon of yet another gene therapy agent deceptively labeled a “vaccine” with limited safety data.
Let’s also look at what happened behind the scenes that led to this reversal and approval. The FDA initially refused even to review Moderna’s application, citing trial design problems and concern that older adults did not receive the best available standard of care during the study. Only months later—after public pressure from Moderna and a change in key FDA leadership—the agency reversed course, convened its advisory committee, and moved the product through.
Those steps matter because they reveal a pattern: the approval of mFlusiva rests on modest benefits, higher rates of side effects, missing data in high-risk groups, and unresolved safety questions from the mRNA platform itself.
How the FDA First Said No – Then Switched to A Rubber-Stamped Yes
The path to approval for mFlusiva was unusually contentious and political. In February 2026, the FDA issued a “refusal-to-file” letter to Moderna, essentially saying the agency would not even start a full review. The reason was straightforward: Moderna had not followed prior FDA guidance requiring comparison to the best available standard of care for older adults—namely, a high-dose flu shot recommended by the CDC for seniors.
Instead, Moderna compared its mRNA vaccine against a standard-dose flu vaccine, which is known to be less effective in older populations. Federal health officials later stated that this choice exposed participants 65 and older to “increased risk of severe illness” by giving them a substandard vaccine. The refusal-to-file decision came from the FDA’s Center for Biologics Evaluation and Research (CBER), led at the time by Dr. Vinayak Prasad, who signed the letter.
After the refusal, Moderna pushed back publicly. The company challenged the decision in the media, there were media “hit” pieces on Dr. Prasad, and the dispute became high profile. Not long afterward, Dr. Prasad left his position at CBER, returning to academia.
Following Dr. Prasad’s departure, the FDA inexplicably reversed course, accepted a revised submission, and agreed to consider full approval for adults 50–64 and accelerated approval for those 65 and older, as long as Moderna promised a new confirmatory study using an appropriate high-dose comparator.
From my perspective as a practicing physician, and to many others even more knowledgeable about usual procedural steps than I am, this sequence raises legitimate questions. The same agency that initially critiqued the trial as not “adequate and well controlled” later accepted the data as sufficient for approval—despite the same underlying issues and only a vague promise of “future studies” – which critically were NOT done prior to approval.
BOTTOM LINE: There is no public proof that the leadership change drove the reversal, but for many of us observing this process, the optics look like the classic “Big Pharma” pressure-driven, regulatory workaround rather than process driven by strict, evidence-based improvement in the actual data being reviewed. That is a clear “buyer beware” warning to consumers.
What mFlusiva Is – And What It Is Not
mFlusiva uses the same basic mRNA technology deployed in the Covid-19 shots, with all the same issues in quality control, batch consistency, and potential for adverse effects in the body that continue over time.
Just as with the mRNA COVID shot, this new mRNA flu shot delivers mRNA instructions that tell your cells to make influenza hemagglutinin proteins to trigger your immune system to react to those proteins and build antibodies. According to the marketing hype, manufacturers can theoretically update mRNA vaccines “faster” than traditional egg-based flu shots, which require months of planning and production. Proponents claim these purported advantages:
Faster production and updating of strains in response to a “shape-shifting” flu virus.
A reported 27% relative increase in protection against lab-confirmed flu compared with a standard-dose comparator.
A new option for older adults, who face the highest risk of serious flu complications.
But those marketing claims and headlines aimed at selling Moderna’s product leave out critical medical context.
First, the 27% figure is relative risk reduction, not absolute risk reduction. In the Phase 3 trial, 2.8% of people receiving a standard flu shot got lab-confirmed influenza versus 2.0% of those getting mRNA-1010.
That 0.8 percentage point difference translates to less than a 1% absolute reduction in flu cases. For most people, that is a very small real-world benefit.
We already have 11 licensed flu vaccines available, including high-dose and adjuvanted versions designed specifically for seniors, so why should elderly patients take risks with an experimental new technology that has not had any long-term studies?
Then there is the issue that the trial only relied on a single flu season. That means no one knows yet how mFlusiva will perform against different strains in future years or when the circulating virus does not match the vaccine quite as well. The efficacy against one flu B lineage (B/Victoria) was so uncertain that the confidence interval crossed zero, meaning the vaccine might offer little to no benefit against that strain.
Efficacy Numbers: Impressive Spin, But What is the Reality for You?
The headline claim is that mFlusiva is “27% more effective” than a standard flu shot. Here is what that actually means:
Among about 20,000 people getting mRNA-1010, 2.0% had RT-PCR–confirmed influenza.
Among about 20,000 people getting a standard-dose flu vaccine, 2.8% had confirmed influenza.
That difference yields a relative vaccine efficacy of 26.6% (the often-quoted “27% more effective”). But it is the absolute risk reduction that translates to what affects YOU.
The absolute risk reduction is only 0.8 percentage points (2.8% minus 2.0%), which means less than one in 100. So your actual risk reduction with this new mRNA shot is in fact not 27% as the ads short. It is only an absolute risk reduction of 0.8%, which is miniscule benefit when you consider all the potential ---known and unknown—risks of the mRNA technology!
The most glaring omission in the trial is that Moderna didn’t test mFLUSIVA against a saline placebo in its pivotal efficacy trial. Roughly 20,000 people used as test subjects got the new mRNA shot. The other 20,000—the supposed “control” group—got another flu vaccine. It may be reasonable to compare an experimental new flu shot against one we already have been using. BUT—there should have ALSO been a placebo (saline injection) control group to compare against both of the active flu shots.
To put this in perspective in a clearer way: imagine 1,000 people taking a standard flu vaccine and 1,000 taking mFlusiva in that trial season. About 28 people in the standard group would get flu versus 20 in the mRNA group. The mRNA shot prevents flu in roughly 8 additional people out of 1,000 in that scenario, while the other 992 people see no difference in outcome—yet all 1,000 are exposed to higher rates of side effects!
I honestly think that the data just do not show that this new product meets a major unmet need or offers a clear, clinically significant safety or efficacy advantage across seasons when compared to the multiple existing NON-mRNA flu shots already approved and widely used, particularly when there are existing ones specifically recommended for older adults, Again, I encourage caution about jumping on this new mRNA flu shot bandwagon.
Safety Signals and Side Effects: More Reactogenicity, New Concerns
The clinical trial data show that mFlusiva is substantially more reactogenic than standard flu shots. That means it triggers more and more intense immediate reactions to the shot. According to a New England Journal of Medicine report:
Injection-site pain: 65.8% in the mRNA group vs 29.8% in the standard flu shot comparator group.
Fatigue: 45.1% in the mRNA group vs 20.3% in the standard flu shot comparator group.
Headache: 37.8% in the mRNA group vs 18% in the standard flu shot comparator group.
Muscle aches: 35.4% in the mRNA group vs 11.6% in the standard flu shot comparator group.
So across common side effects, the mRNA shot roughly doubles or triples the rates seen with a traditional flu vaccine. These reactions are often dismissed as “mild” or “temporary,” but they still cause problems for people that may lead to missed days from work.
Even more alarming in my view is that the mRNA group in the trial experienced six times more severe adverse reactions than the comparator group using standard flu shots.
And in older adults with frailty, multimorbidity, or borderline functional reserves, the increase in both immediate common reactions and the more severe adverse reactions can trigger falls (with risk of head injuries, fractures), exacerbations of chronic disease, or hospitalizations.
There were also 23 deaths in the mRNA-1010 arm compared with 9 in the standard-vaccine group. The advisory committee quickly waved away this mortality imbalance as unlikely to signal a real safety problem, but that decision rests on judgment, not on clear proof of absence of risk.
BOTTOM LINE: When we as physicians are recommending any new medication or vaccine for millions of mostly healthy older adults every year, all of these unresolved questions should matter MORE—not less.
This is exactly the problem we saw with the COVID shots when early warnings were brushed aside and the shots deployed worldwide into several billion people and the damage exploded. It appears we are being set up to once again see far too many healthy people suffer needless risks, long term adverse effects, and even death. I find it unacceptable and quite alarming that the FDA advisory panel simply brushed off these concerns and approved the new mRNA shot anyway.
Missing Data Where Risk Is Highest
Moderna’s own prescribing information package insert says in Section 13.1: “MFLUSIVA has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility in animals.”
That’s not my wording. That’s from Moderna on their label. And based on what I have seen in my own patients experiencing complications from the COVID mRNA shots, this warning is only the tip of a very large iceberg of potential damage and long term health risks.
Then, consider these issues beyond the general safety signals. The limited trial leaves significant gaps in exactly the populations most at risk from both flu and mRNA-related adverse effects:
Immunocompromised patients were not studied, despite being at high risk of severe influenza and potentially abnormal responses to mRNA technology.
Very frail older adults were not adequately represented, yet they are the ones most commonly targeted for aggressive vaccination campaigns.
There are no data on co-administration with other recommended respiratory vaccines such as Covid-19 boosters, RSV vaccines, or pneumococcal shots.
The evidence is based on just one season of follow-up, with no long-term safety tracking for outcomes like myocarditis, autoimmune disease, or cancer acceleration.
BOTTOM LINE: FDA scientists themselves flagged these evidence gaps in internal review documents in their usual careful bureaucratic language designed to obscure a simple reality: we do not know how this product behaves in the very people who will be told they “need” it most. The FDA scientists also noted that these evidence gaps in the mFlusiva trial also “lower the applicability of the efficacy data to a substantial portion of the intended patient population.”
The mRNA Platform’s Track Record: Covid-19 Lessons Ignored
The approval of mFlusiva did not occur in a data vacuum. It comes after five full years of intense global experience with mRNA Covid-19 gene therapy agents being called vaccines. While authorities initially framed those shots as safe and effective, frontline clinicians and independent researchers have documented a dramatically increasing and continuing list of serious complications associated with the mRNA platform, including:
Sudden death, not just older people, but children and young healthy adults, including elite athletes who just drop dead with no warning.
Myocarditis and pericarditis, especially in younger males but not limited to that group.
Autoimmune phenomena, from new-onset rheumatologic disease to neurologic syndromes.
Alarming neurological disoders across the whole spectrum of brain and nerve damage.
Unusual patterns of rapidly progressive or “turbo” cancers temporally associated with repeated mRNA exposure in some case series.
Persistent or recurring inflammatory and vascular problems in subsets of recipients.
Recurrent miscarriages, menstrual irregularities, infertility and premature menopause in women after the mRNA COVID shots, and damage to sperm and testosterone production in men.
Independent groups of physicians and scientists around the world routinely warn that they are seeing “mRNA-induced health crises” in clinical practice, including sudden death, heart inflammation, endocrine damage, brain and nerve damage. autoimmune disorders, and aggressive cancer recurrence.
I realize that not every association proves causation, but the sheer volume severe and very alarming safety signals that have consistently followed the mRNA COVID shots in every country deploying them should trigger a more cautious, not more aggressive, expansion of this technology into routine, annual vaccines for older adults.
Recently, Dr. Makis, a top oncologist and outspoken advocate against this dangerous technology, stated that those who took COVID-19 Vaccines and were severely injured have either already “died suddenly” or are currently dealing with “Turbo Cancer” or severe autoimmune disease and not likely to rush to get a new mRNA flu shot. He went on to say But there are millions who took 2 or 3 COVID-19 Vaccines and still say they feel fine, and it is these individuals that have suffered mild to moderate immune system damage (subclinical immune damage) but don’t know it. Their immune system may barely be hanging on, but cannot sustain another mRNA attack, which is precisely what the Moderna mRNA Flu vaccine is.
BOTTOM LINE: Moderna’s mRNA Flu vaccine has the potential to do the most damage to the most compliant patients because their subclinical immune dysregulation or microvascular injury has not yet fully manifested. Giving those individuals another mRNA-based injection every flu season, is a gamble with their health akin to a game of Russian roulette.
Regulatory Capture and Conflicts of Interest
Major conflict of interest: The advisory committee that unanimously recommended approval for both age groups (9–0 votes) included members with prior service on Moderna advisory boards and data safety monitoring boards, as well as ties to other vaccine manufacturers. For example, committee member Flor Munoz-Rivas previously served on Moderna’s Vaccines Advisory Board. These relationships are disclosed, but disclosure alone does not erase the underlying conflict.
In an ideal world, following the ethical guidelines that should be required, regulatory decisions for new technologies—especially those rolled out to millions of healthy people—would be made by panels free from financial or professional ties to the companies whose products they oversee. This was the ethical basis for the NEW ACIP panel Secretary Kennedy attempted to create, but which was blocked by one of the liberal rogue federal judges.
Instead, we see a troubling pattern: a new mRNA product with modest benefit, higher side-effect rates, incomplete safety data, and open questions about mortality nevertheless sails through with unanimous votes from a committee populated by individuals with industry ties.
BOTTOM LINE: We are seeing the results of regulatory capture: the gradual alignment and co-opting of regulatory agencies by the industries they are supposed to police. When the same institutions that initially insist on rigorous standards later relax those standards under pressure, it is no wonder that public trust erodes rapidly—and rightly so.
Do We Need an mRNA Flu Shot at All?
I think one of the most basic questions of all is one that is hardly ever asked in mainstream coverage: WHAT IS THE UNMET NEED THAT mFlusiva is supposed to solve? We already have 11 influenza vaccines licensed in the U.S., including high-dose and adjuvanted options that were specifically developed to improve protection in older adults.
mFlusiva does not clearly outperform high-dose or adjuvanted vaccines in any clinically meaningful ways.
mFlusiva offers a miniscule (0.8%) absolute reduction in flu cases.
mFlusiva was only ever tried in one flu season.
mFlusiva causes marked increase in immediate reactogenicity.
mFlusiva led to SIX times greater number of serious adverse side effects than traditional flu shots.
mFlusiva rides on the mRNA novel technology platform that already demonstrated with the mRNA COVID shots a world-wide marked increase in harms, including sudden deaths and devastating debilitating ongoing damage.
BOTTOM LINE: My view is that if we really want to help protect older adults from influenza hospitalization and death, we already have readily available tools —with longer safety track records and less systemic uncertainty. It does not make sense to me to do yet another mRNA experiment on the public and further extend use of this new, complex technology when we have no data to show clear, compelling advantages and we have not even attempted to resolve major safety questions. Approving another mRNA shot for flu is not “following the science.” It is expanding Pharma profits, while risking harm to patients.
A Clear Warning for the Public
Putting all of this together, we face a stark reality. Moderna’s mFlusiva has been approved not because it clearly and meaningfully improves health outcomes for older adults, but because it offers modest statistical gains over a weaker comparator, while regulators and manufacturers work around their own earlier standards and concerns.
Key populations remain unstudied, long-term safety is unknown, and the mRNA platform’s existing track record is deeply troubling. For example, Section 13.1 of the prescribing information from Moderna states, as I mentioned earlier in my article: “MFLUSIVA has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility in animals.”
For these reasons, a prudent, informed approach based on actual evidence would be these recommendations:
Do not accept this new mRNA flu shot simply because it is labeled “approved” or “cutting-edge.”
Do not assume that unanimous advisory committee votes equal comprehensive safety review or even unbiased decision-making.
Do not allow marketing language about “faster manufacturing” or “27% more effective” to overshadow the tiny absolute benefits (0.8%) and the significantly higher rates of adverse reactions.
Do not ignore the lessons of the Covid-19 mRNA rollout, especially if you already received multiple mRNA injections.
Older adults, particularly those who have previously received mRNA Covid shots or who have complex medical histories, should exercise extreme caution before deciding to accept the new mRNA flu shot, mFlusiva.
If you feel you need a flu shot, it would be wiser to consider the alternative, non-mRNA influenza vaccines with longer safety records. You can simply tell your doctor you want the “old” traditional flu shot, not the new mRNA one and insist on that!
BOTTOM LINE: At this time, there is too little independent, long-term information to warrant my suggesting you consider placing trust for your health in this new mRNA product or in the regulatory process that pushed it forward. Your health should not be the testing ground for a technology that has already shown the capacity to cause serious harm. Until robust, transparent, and long-term data demonstrate that mFlusiva is both safer and more effective than existing options, the safest position for the general public is to refuse this new mRNA flu vaccine.
REMEMBER: You have the right to refuse the new mRNA shot, and if you want to get a flu shot, simply tell your doctor “I am uncomfortable with the new mRNA shot, I want the same traditional flu shot I’ve had before.”
But even our existing flu shots carry risks of adverse side effects and have minimal absolute risk reduction, so perhaps in consultation with a trusted clinician, you may decide to opt out of flu shots entirely and turn to the natural medicines, supplements and good hygiene practices our grandmothers taught us that have worked for generations!
if mRNA flu vaccine was not to be approved, it was HHS and RFK Jr. who was to do this...so its on him...his role is to bring mRNA, not end it. we were so fooled. there is nothing he knows about the mRNA that we do not.
support Dr. Vliet. she is exceptional.