Just Ahead of Flu Season, FDA Approves First mRNA Vaccine for Older Adults
The FDA approved a new mRNA flu vaccine for older adults ahead of the upcoming 2026–2027 flu season. fotostorm/E+/Getty Images
The Food and Drug Administration (FDA) has approved a new mRNA flu vaccine for older adults.
The new flu shot, called mFLUSIVA, was found to be effective in clinical trials in preventing serious illness in people ages 50 to 64.
The vaccine was also given accelerated approval for people 65 years and older, although more research is being conducted on that age group.
A new flu vaccine that uses the same type of technology as the COVID-19 inoculations will be available this influenza season for older adults.
The Food and Drug Administration (FDA) has approved the first mRNA-based flu vaccine for people 50 years and older.
The vaccine, known as mFLUSIVA, is manufactured by Moderna, one of the companies that provided COVID-19 vaccines during the pandemic.
The mRNA flu vaccine was approved by the FDA for use in adults 50 to 64 after a phase 3 clinical trial involving more than 40,000 adults ages 50 and older in 11 countries.
The study showed that their vaccine was 26% more effective than a licensed standard-dose flu vaccine.
The vaccine was also granted accelerated approval by the FDA for adults ages 65 and older based on results from a clinical trial involving nearly 3,000 adults in that age group in the United States.
Learn more about the new mRNA flu vaccine, plus what to expect for the upcoming 2026–2027 flu season.
How is mRNA technology different from other flu shots?
Moderna officials reported their vaccine generated stronger antibody responses than Sanofi’s high dose flu vaccine in adults 65 and older.
Moderna officials have agreed to run an additional study and submit more data in adults 65 and older to confirm the vaccine’s benefit in that age group.
The mRNA flu vaccine is currently under regulatory review in Europe, Canada, and Australia.
Flu vaccines currently manufactured by Sanofi, GSK, CSL Seqirus, and AstraZeneca will also be available. None of those shots is mRNA-based.
The mRNA technology is designed to prompt the body to produce influenza antigens and trigger an immune response, an approach that could potentially allow faster updates to match circulating strains.
Conventional flu vaccines are largely egg-based and contain viral proteins that trigger an immune response in the body.
The FDA’s approval of Moderna’s new flu vaccine comes one year after Health and Human Services Secretary Robert F. Kennedy Jr. announced that HHS would cut $500 million in funding for 22 mRNA vaccine development programs.
Kennedy criticized mRNA vaccines, saying the technology “failed to protect” against respiratory diseases such as COVID-19 and influenza.
How effective is new mRNA vaccine against the flu?
Officials say it’s too early to predict how severe the 2026-2027 flu season will be in the United States and the rest of the Northern Hemisphere.
So far, officials at the Centers for Disease Control and Prevention (CDC) report that influenza activity remains “very low” during the summer months.
That corresponds with Australia, which has reported a moderate to lower-than-average flu season in the Southern Hemisphere during its winter months of June and July.
Last year, Australia experienced its deadliest flu season of the 21st century with nearly 500,000 cases and 1,700 deaths. The severity was largely driven by a flu variant known as Super K.
The United States experienced a “moderately severe” flu season last winter, spurred mostly by the H3N2 variant of influenza A.
Experts say the new mRNA flu vaccine should be a benefit to older adults in the coming flu season.
“I view the FDA approval of mFLUSIVA as an important addition to our influenza prevention toolkit, particularly because adults over 50 begin to experience a progressively higher risk of serious complications from influenza,” said Dung Trinh, MD, an internist at MemorialCare Medical Group and chief medical officer of the Healthy Brain Clinic in Irvine, CA.
“This is also a significant scientific milestone because it is the first mRNA-based seasonal influenza vaccine approved in the United States, showing that mRNA technology can be applied beyond COVID-19,” Trinh told Healthline.
“I think the appropriate way to view this is not as a replacement for every existing flu vaccine, but as another evidence-based option that could ultimately give physicians and patients more choices in protecting people at higher risk from influenza,” he added.
David Cutler, MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California, also expressed guarded optimism about the new vaccine.
“My overall view is cautiously favorable,” he told Healthline. “The FDA approval of Moderna’s mFLUSIVA (mRNA-1010) is scientifically interesting and potentially important, but I would not interpret it as proof that the mRNA vaccine is necessarily the best flu vaccine for every person over 50.”
Cutler and Trinh both said the clinical trial with participants ages 50 to 64 was thorough and conclusive. They added that more research should be done on the effectiveness of mFLUSIVA in people ages 65 and older. They also noted that mRNA vaccines can be redesigned as flu viruses mutate.
“That could become increasingly valuable for influenza, where vaccine-virus mismatch is a perennial problem,” Cutler said.
Cutler noted that he didn’t see a contradiction between the FDA approval of the vaccine and the HHS decision to cut funding. He said the FDA is studying current vaccines while HHS officials are looking at future developments.
“An FDA approval does not invalidate the government’s decision about how to allocate research dollars,” he said. “Conversely, withdrawing government funding does not demonstrate that an mRNA vaccine is ineffective.”
Why it’s important to get a flu shot
Influenza is a contagious viral infection that is most prevalent during the fall and winter months.
The most common symptoms of the flu are:
fever
cough
muscle aches
headache
fatigue
Most people recover from the flu in two weeks or less. People with the flu can drink plenty of fluids, get adequate rest, and frequently wash their hands to reduce the risk of spreading the illness to others.
There are also over-the-counter medications such as decongestants and cough suppressants that can be taken to relieve symptoms. Prescription antiviral medications like Tamiflu are also available.
Experts agree that the best way for a person to reduce their risk of serious illness from influenza is to get an annual flu shot. They say this is particularly true with older adults.
“Influenza should never be dismissed as simply a bad cold, particularly in older adults,” said Trinh. “As we age, our immune defenses change and people 65 and older have substantially higher rates of influenza-related hospitalization, serious complications and death than younger healthy adults.”
“I consider influenza vaccination an important part of healthy aging,” Trinh added. “We are not merely trying to prevent several unpleasant days of illness. We are trying to preserve health, function, and independence and reduce the risk of the serious consequences influenza can have in a vulnerable older adult.”
Cutler agreed. “Influenza isn’t simply a few days of fever and aches in older people,” he said. “Aging produces immunosenescence, and older adults are much more likely to develop complications.”
However, Cutler thinks it might be wise for people 65 years and older to wait for more research to be completed before getting the new mRNA flu vaccine.
“For someone over 65, there are already enhanced influenza vaccines — including high dose and adjuvanted vaccines — specifically intended to overcome the diminished immune response associated with aging,” he said.
Trinh adds that people should not base their decision on whether to get a flu vaccination on predictions on how serious an upcoming flu season might be.
“My message to patients is that we should prepare for flu every year rather than gamble on whether a particular season will be severe because by the time we know definitively that a bad season has arrived, transmission is already occurring,” he said.
