The new flu vaccine, mFlusiva, is specifically designed for individuals aged 50 and above.
WASHINGTON — In a groundbreaking development, the Food and Drug Administration has given the green light to a novel flu vaccine crafted for the older population. This vaccine is the first in its category to employ the revolutionary mRNA technology, which played a pivotal role in overcoming the COVID-19 pandemic, according to Moderna, its developer.
Targeting adults 50 and older, mFlusiva joins a variety of flu shots already making their way to pharmacies as fall vaccination season draws near. Moderna announced, as of late Wednesday, August 5, that it anticipates limited supplies of its innovative vaccine will soon be stocked at select retail locations.
Despite the availability of numerous flu vaccines in the U.S.—including three tailored specifically for those 65 and older—flu complications claim tens of thousands of American lives each year, with seniors being particularly at risk.
Seasonal flu vaccines require annual updates to align with the circulating virus strains. The vaccines utilizing the Nobel Prize-winning mRNA technology can be produced more swiftly than traditional methods. Experts suggest that this new mRNA option may prove invaluable if the ever-evolving flu virus undergoes a mutation necessitating a rapid production of updated doses.
Moderna said the FDA granted full approval for mFlusiva’s use in people ages 50 to 64, based on a study of 40,000 people that found 27% fewer flu cases among people who got the new shot compared with those who got a different common flu vaccine brand. For people 65 or older, the Cambridge, Massachusetts-based manufacturer said the FDA granted what’s called accelerated approval for the shot — based on a smaller study showing it generated a strong immune response compared with an existing high-dose vaccine for seniors — while it conducts an additional study.
Moderna’s data showed no major safety issues, although the shot did cause some temporary reactions including injection site pain, fever, headache, tiredness and aches that occurred somewhat more than with today’s flu shots.
The FDA action comes after a highly unusual public dispute over mFlusiva earlier this year. A then-top FDA official blocked the company’s application, a sign of the agency’s heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr. Days later, the agency changed course after Moderna publicly challenged the ruling — and in June, a panel of independent advisers to the FDA unanimously recommended the vaccine’s approval.
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