The Food and Drug Administration gave final approval in August for Moderna’s mFlusiva, the nation’s first flu vaccine that uses messenger RNA technology. The clearance applies to adults 50 and older, with traditional approval for ages 50‑64 and accelerated approval for those 65 and older pending a post‑approval study.
Who can receive the new shot
Pharmacies across the country will offer mFlusiva only to patients who have already celebrated their 50th birthday. “If you have not celebrated your 50th birthday, this vaccine should be of no interest to you,” said independent pharmacist Emlah Tubuo of Ohio. Adults younger than 50 will continue to receive the standard seasonal flu vaccines approved for their age group.
Effectiveness and safety
A late‑stage trial published in the New England Journal of Medicine in May showed mFlusiva to be about 27% more effective than a traditional flu shot at preventing laboratory‑confirmed influenza illness. The study enrolled more than 40,000 participants aged 50 and older across 11 countries, including the United States.
FDA reviewers found no serious safety concerns. Side effects such as injection‑site pain, fatigue and headache were reported more often with mFlusiva than with the standard vaccine, but they were described as mild to moderate. Infectious‑disease specialist Dr. William Schaffner of Vanderbilt University noted that the higher rate of side effects likely reflects a robust immune response.
How the mRNA technology differs
Traditional flu shots use a deactivated virus, often grown in eggs, to teach the immune system to recognize influenza. mFlusiva, by contrast, delivers a short snippet of genetic code that instructs cells to produce a piece of the flu virus, prompting the body’s natural defenses to respond. The mRNA is broken down and does not remain in the body after vaccination.
Because the mRNA platform can be manufactured more quickly, Moderna says it can produce the vaccine in two to three months instead of the six months required for conventional flu vaccines. This faster timeline allows manufacturers to wait longer before selecting the strains most likely to circulate, potentially improving match accuracy.
Availability and insurance coverage
Moderna has begun shipping doses to pharmacies nationwide. CVS Health confirmed the vaccine is already in its U.S. stores, while Walgreens expects to receive shipments soon, though supplies will be limited early in the season.
A spokesperson for the Association of Health Insurance Plans (AHIP) indicated that most private insurers are expected to cover the vaccine. Medicare is required to fully cover FDA‑approved seasonal flu shots, according to vaccine policy expert Dorit Reiss of UCSF. Coverage under Medicaid remains uncertain, as the program typically waits for a formal recommendation from the CDC’s advisory committee before providing reimbursement.
Cost to consumers
Without insurance, the price tag for mFlusiva is around $171 per dose, according to the Centers for Medicare & Medicaid Services. Some pharmacies list the cost as low as $154, based on GoodRx data.
What patients should expect
Like any vaccine, the timing of availability will depend on each pharmacy’s inventory and delivery schedule. Tubuo noted that demand for the new shot is currently low, as many people wait until October to seek flu vaccination.
Importantly, mFlusiva does not protect against Covid‑19. It is a separate product from Moderna’s combination Covid‑flu vaccine, which received approval in the European Union earlier this year.
Original reporting: NBC10 Boston — read the source article.
