New flu vaccine comes with a dose of uncertainty
The 2025-26 flu season was a humdinger. About 31 million flu-related illnesses and 24,000 deaths were reported — from a disease that can be mostly prevented or at least mitigated with an annual flu shot.
This year’s flu season, however, brings with it a new flu vaccine that works differently from the traditional ones. It holds promise, but I don’t think you should rush out and find it just yet.
Earlier this month, the FDA approved mFLUSIVA, an mRNA flu vaccine from Moderna. It was mRNA technology that allowed the creation of COVID-19 vaccines so quickly during the pandemic and, even though controversy and skepticism persist, the vaccines had a role in ending the pandemic and getting us back to our usual lives.
The flu vaccine created through mRNA (or “messenger RNA”) doesn’t have to be incubated in chicken eggs like traditional vaccines. The encoded genetic information instructs the body to produce a fragment of a virus that then sets off a stronger immune response that was 27% more effective than regular flu shots, according to the FDA.
The formula can be adjusted to “rapidly emerging new flu strains, a capacity we have not had before,” Georges C. Benjamin, executive director of the American Public Health Association, told the New York Times. It was approved for adults over the age of 50, especially those with underlying health conditions.
The vaccine is being rolled out this fall, but there are a few caveats.
One is side effects. The stronger immune response may mean that you experience more in the way of fever, injection-site pain and headache than with the traditional vaccine. That’s to be expected; however, some people may wish to avoid those side effects.
Another is availability. Moderna says mFLUSIVA will be available “in a few weeks” at “select retailers” this fall, but we don’t know what that means yet for your local pharmacy.
There’s also a question of ongoing testing. The FDA granted accelerated approval in time for the coming flu season based on a Phase III clinical trial with more than 20,000 participants. This allows Moderna to market and distribute mFLUSIVA, but final approval depends on the outcome of a Phase IV clinical trial to verify its benefits.
Who will pay for the new vaccine? It might be you.
Medicare, Medicare Advantage and private insurers typically won’t cover a vaccine until it’s approved by a CDC committee known as ACIP, the Advisory Committee on Immunization Practices. The committee hasn’t met for over a year after a judge voided appointments made by Robert F. Kennedy Jr., secretary of Health and Human Services. A new CDC director was only recently confirmed by the Senate. Stay tuned.
The takeaway is clear: Do not assume mFLUSIVA will be covered at zero cost. Contact your health insurance provider or Medicare plan directly to verify whether you’ll have to pay out-of-pocket.
And don’t wait to see if you can get the mRNA vaccine. Protect yourself and your family by getting regular flu shots as early in the season as you can. Remember that it takes about two weeks for your body to develop enough antibodies to fight off the flu.
Flu season is inevitable. Getting the flu doesn’t have to be.
• Teri (Dreher) Frykenberg is a registered nurse and board-certified patient advocate. She is the author of several books on advocacy and founder of Nurse Advocate Entrepreneur, which equips medical professionals with the knowledge and skills to start their own advocacy businesses. Contact her at Teri@NurseAdvocateEntrepreneur.com.