Despite a number of significant limitations in the available safety and efficacy data for licensure review of Moderna, Inc.’s new mRNA influenza biologic mFlusiva, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee ((VRBPAC) voted on June 18, 2026 to recommend fast-tracked licensure of the first mRNA product to target seasonal influenza for use in adults 65 and older and for a traditional approval process for adults 50 to 64 years of age.1 2
During discussions on the safety and efficacy data submitted by Moderna for accelerated approval of its experimental mRNA (messenger ribonucleic acid) annual flu shot for seniors over age 65, including those who are frail, the FDA advisory panel determined that the benefits of administering mFlusiva (formerly mRNA-1010) outweighs its risks and voted unanimously (9 to 0) to recommend favorable consideration by the FDA.1 2
Speed and Efficacy Rule the Day
Perhaps the biggest argument made during the VRBPAC meeting for switching to mRNA based biologicals from traditional influenza vaccines that use eggs and insect cells for production is the greater production speed offered by the mRNA technology, which also allows a more timely prediction of circulating strains to more accurately match the vaccine strains. In other words, mRNA technology provides drug companies with an accelerated production process that cuts down on research and development costs and makes it easier to match circulating strains with strains included in the vaccine.
In Moderna’s presentation to the panel, Rituparna Das, MD, PhD noted that “current influenza vaccine technologies can be affected by the long interval between strain selection and vaccination.”2 She added:
By directly encoding the selected antigen sequence, avoiding egg adaptation and supporting a more flexible manufacturing timeline, mRNA-1010 has the potential to address important limitations of current influenza vaccines and improve protection in a population that continues to experience substantial influenza disease burden.2
According to panel member Flor Muñoz-Rivas, MD of Texas Children’s Hospital:
Having this technology available puts us in a better position to be prepared for emerging strains in the future.1
The members of the panel were presented with data showing a 26.6 percent higher efficacy of mFlusiva than a licensed standard-dose flu vaccine. This may well have been the deciding factor, “It’s great to see the higher efficacy compared to existing vaccines,” said panel member Adam Berger, PhD of the National Institutes of Health (NIH). However, the study demonstrating superior efficacy only evaluated one influenza season and different strains can circulate in different flu seasons, meaning critical long term efficacy data is missing.2 3
And it probably would have been more revealing to compare mFlusiva’s efficacy with that of the high-dose, recombinant, or adjuvanted influenza vaccines recommended by the U.S. Centers for Disease Control and Prevention (CDC) for elderly individuals.4
Safety, Not So Much
Clearly, any safety concerns about mFlusiva were minimized in panel discussions. Dr. Berger, for example, said that evidence “largely supports the safety and effectiveness” of the biologic. He characterized the safety data as “relatively reassuring.” Not exactly a strong vote of confidence for this experimental biologic that employs a new and extremely controversial technology (mRNA) for which there are no good long-term safety studies.2
Berger’s lukewarm comments on the safety aspects of the product are particularly troubling, given no safety studies have been done on the health impacts of administering mFlusiva to patients, who have also received one or more other routinely recommended respiratory vaccines such as COVID-19, RSV (Respiratory Syncytial Virus), and pneumococcal vaccines, or will receive them simultaneously in the future. Also, studies were not done giving mFlusiva to immunocompromised individuals. Very frail older adults with co-morbidities were not included in the clinical trials for the product, two groups which Nicholas Jacobus pointed out in a PharmExec.com article are “most likely to respond differently to mRNA-based vaccine platforms.”4 5
These are no small gaps in data and fundamental understanding of the risk profile of mFlusivia. The lack of evidence for safety in the vulnerable elderly population appears to have been minimized and conveniently shoved aside by VRBPAC.
A decision by the FDA on mFlusiva is expected to be made by Aug. 5, 2026. If the licensure application for the experimental biologic is approved, it would make mFlusiva the the first mRNA-based seasonal flu shot in the United States.3
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Click here to view References:1 Neergaard L, Perrone M. FDA panel backs first-of-its-kind flu vaccine using mRNA technology. Associated Press June 18, 2026.
2 Sagonowsky E. Moderna’s flu candidate sails through FDA advisory committee in unanimous votes. Fierce Biotech June 18, 2026.
3 Vega E. FDA Advisory Panel Votes Today on First mRNA Flu Vaccine as MFLUSIVA Phase 3 Results Face Intense Scrutiny. Medical Daily June 18, 2026.
4 Cáceres M. FDA Set to Review Moderna’s mFlusiva mRNA Flu Shot. The Vaccine Reaction June 18, 2026.
5 Jacobus N. FDA Files Concerns Over Missing Data for Moderna’s mRNA Flu Shot: Report. PharmaExec.com June 17, 2026.
26 Responses
Sorry FDA, you lose again. Your lies are known to all of us seniors. No vaccines ever for me. Please explain why I should poison myself with toxic crap like vaccines?
Thank You Tom!!! I agree with what you wrote!!!
I agree with Tom, too.
Bravo!
Agree
Well that makes sense. They didn’t kill enough of the old folks with the COVID scam now they have another jab to do away with many more. Well this old lady will not be taking any of their poisons into my body. Never have. Never will. WAKE UP AMERICA.
Same Here!!!!!
Indeed, and it will just get worse
FOX dummy ‘doctor’ Siegel was smiling broadly he praised the jab. I guess all the deaths, that continue today, and maiming are all unworthy to consider
It was, it still is
genocide,
GREED,
and an insatiable need for
CONTROL
Hey! They had to do SOMETHING to try to fix the SS mess that Clinton caused. The did let Killary weigh in on the solution.
NO mRNA ANYTHING!!!!!!!
I will not be taken any more vaccines ever. I am healthy and plan to stay that way by avoiding as many toxins that I can. The top of that list is vaccines. I agree that they are not interested in the health or well being of the “old folks”.
When the inevitable harm occurs they will say; We’re not sure exactly why the people were injured, but we’re certain it was not the vaccine.
Fast tracked approval. For the laymen that means the pharmasuetical company demanding approval paid higher fees, the government employees get big bonuses. Pay to play; Fast Track.
Who wouldn’t give themselves a raise? What these people are doing is not science. They are not experts.
They’re trying to save on Social Security payments again. I do not get any vaccines. I was smart enough to research during COVID. Remember to question vaccines at the vet also.
We need this vaccine. Without it, millions of seniors won’t die. What about social security? It’s about to go broke. Plus just look at the revenue the last mrna kill shot produced : turbo cancer, micro clotting, fibrous vascular obstructions and the list goes on. Stop being nattering nabobs of negativism and embrace the love-shot.
Fool me once shame on you, fool me twice shame on me. You almost got rid of me the first time…….no more chances for you to lie to me again!
Guess they did not see sufficient deaths among the elderly earlier from the jab
Just proves what reputable healthcare providers warned in ’20 including my naturopath who said “From now on they will load mRNA into all vaccines and any new ones they create”
I will wait a few years and then re evaluate the situation. i’m a healthy 75 y/o. Getting the flu is no fun at all but this new mRNA biological agent is too new and i want to see more data on the safety aspect. Time will tell if NIH and FDA make it an ongoing mission to track this with transparency and full disclosure and without pharma interference and prejudice .
Consider optimizing your vitamin D levels and take vitamin C which peaks in concentration 2 hours after ingestion and is eliminated around four hours. Be aware frequent use of vitamin C can be associated with diarrhea, and endogenous oxalate production which can exacerbate gout, arthritis, and kidney stone risk. Titrate according to personal tolerance. Also, a low carb, ketogenic, or carnivore way of eating gives a strong boost to innate aka adaptive immunity our most important line of defense.
Recall the study on covid vaccine outcomes using Denmark medical data that revealed there were three levels of vaccination: placebo, a base dose, and a higher dose that was associated with more serious adverse events that was sometimes termed hot batches. There was no informed consent explaining getting the covid shot meant a person would unknowingly get one of these three concentrations. AFAIK there were no repercussions and no international medical scandal over those findings besides skeptics on social media frequently censored and treated like outcasts. How can those designing the policies for mRNA injections be trusted?
That’s why the elderly and the disabled got the first batch of shots. I remember saying to my husband. We are the first to get rid of. Read the book Bad Pharma it’s eye opening. . I haven’t had any vaccines in my life except those at childhood polio and smallpox. And I plan to keep it that way
Big pharma and the medical industrial complex keep pushing. The FDA, CDC and NIH keep allowing themselves to be influenced and compromised. We keep hearing talk. The evidence is there. When will the criminals be held accountable, and medicine get back to the business of healing, not greed and avarice? What happened during Covid should have been the mother of all wake-up calls.
FDA, using our tax dollars to fast track a vaccine we are too smart and informed to take. One must wonder how far they hope to push this.
No vaccines, no problem.
So much for MAHA. It’s the same old FDA, rubber stamping pharma’s poisons. I guess RFKjr didn’t fire enough people.
safety data?? Safety data?
FDA don’t need no stinking safety data.
What could possibly go wrong?
I’m sure that will be real successful in increasing the death toll.