First mRNA influenza vaccine launched; suitable for people aged 50 and older
Moderna’s first mRNA-based influenza vaccine, “mFlusiva,” is now available in pharmacies, though not everyone is eligible to receive it. The FDA approved mFlusiva for individuals aged 50 and older back in August, and the CDC recommends that eligible individuals complete their vaccination by the end of October.
According to NBC News, the FDA granted traditional approval for mFlusiva for adults aged 50 to 64 and accelerated approval for those aged 65 and older. However, the agency also required Moderna to conduct an additional trial because the original study used a standard-dose vaccine as the comparator, whereas the CDC recommends high-dose vaccines for seniors aged 65 and up.
The FDA had initially declined to review the vaccine but later reversed its position; an independent vaccine advisory panel voted unanimously in June to recommend approval.
“If you haven’t turned 50 yet, this vaccine isn’t for you,” said Emlah Tubuo, an independent pharmacist in Ohio.
Those under the age of 50 must receive other FDA-approved flu vaccines this season.
A late-stage clinical trial published this May in the New England Journal of Medicine (NEJM)—a leading global medical journal—involved more than 40,000 adults aged 50 and older across 11 countries. The results showed that mFlusiva was approximately 27% more effective at preventing influenza than standard-dose flu vaccines.
Trial participants reported that side effects such as injection-site pain, fatigue, and headaches were relatively common but mild to moderate in severity; otherwise, FDA reviewers identified no serious safety concerns regarding the vaccine.
William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, noted that this might “reflect the strength of the immune system’s response to the vaccine.” The vaccine targets only influenza and does not protect against COVID-19.
mFlusiva has a production cycle of about two to three months, compared to roughly six months for traditional vaccines; Schaffner explained that this shorter production timeline allows researchers more time to determine which viral strains to target. mFlusiva has reached pharmacies without a formal recommendation from the CDC or its vaccine advisory committee—a step usually required for insurance companies to cover a vaccine.
A spokesperson for America’s Health Insurance Plans (AHIP) anticipates that most private insurers will provide coverage.
Dorit Reiss, a vaccine policy expert at UC Law San Francisco, noted that Medicare must fully cover FDA-approved seasonal flu vaccines, whereas the scope of coverage under Medicaid for this season remains unclear.