This new kind of flu shot by Moderna has just been approved by the FDA
The Food and Drug Administration has approved a new kind of flu vaccine for older people, the first made with the same mRNA technology that was key to ending the COVID-19 pandemic, said the manufacturer, Moderna . The shot, named mFlusiva, is intended for adults who are 50 and older. Other brands of flu shots already have begun arriving in pharmacies ahead of fall vaccination season, and Moderna…
The U.S. Food and Drug Administration has recently approved a novel flu vaccine called mFlusiva developed by Moderna, the first of its kind using the same mRNA technology that played a crucial role during the COVID-19 pandemic. This vaccine is intended for adults aged 50 and above. mFlusiva is currently expected to be available in pharmacies soon, following its approval.
Although multiple flu vaccine options are already available in the U.S., including those specifically recommended for individuals aged 65 or older, influenza remains a significant health concern as tens of thousands of Americans lose their lives to the virus each year. Older adults are particularly vulnerable.
Every year, flu vaccines need to be updated to match circulating virus strains better. Vaccines utilizing the Nobel Prize-winning mRNA technology are faster to manufacture than other types. This supplementary option might be beneficial if the flu virus mutates and suddenly requires the production of new doses. Moderna, based in Cambridge, Massachusetts, stated that the FDA approved mFlusiva for use in individuals aged 50 to 64 after a study of 40,000 people, which found the new vaccine to reduce flu cases by approximately 27% compared to another commonly used flu vaccine brand.
For those 65 and older, Moderna received accelerated approval from the FDA, based on a smaller study showing a strong immune response compared with an existing high-dose vaccine for seniors. This approval is contingent upon an additional postmarketing study.
Moderna's data indicated no major safety concerns with the vaccine, although some temporary reactions such as injection site pain, fever, headache, tiredness, and body aches occurred more frequently than with current flu shots. The FDA's decision comes after a highly unusual public dispute over mFlusiva earlier this year, which involved a then-top FDA official blocking the company's application.
Days later, the agency reversed its decision after Moderna publicly challenged the ruling. In June, a panel of independent advisers to the FDA unanimously recommended the vaccine's approval.
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