Washington: 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, manufacturer Moderna said.
The shot, named mFlusiva, is intended for adults aged 50 or older. Other brands of flu shots have already begun arriving in pharmacies ahead of the fall vaccination season, and Moderna said on Wednesday that it expects some of its new version to be available soon at select retailers.
Flu vaccines must be updated annually to best match circulating strains of the virus. Vaccines made with the Nobel Prize-winning mRNA technology are faster to manufacture than other types, and experts say this additional option might help if the shape-shifting flu virus mutates in a way that requires rapid production of new doses.
While there are already multiple flu vaccine options in the US, including three specifically recommended for people aged 65 or older, tens of thousands of Americans die from influenza every year, and older adults are among the most vulnerable.
Moderna said the FDA granted full approval for mFlusiva's use in people aged 50 to 64, based on a study of 40,000 people that found 27 per cent fewer flu cases among those who received the new shot compared with those who received a different common flu vaccine brand.
For people aged 65 or older, the Cambridge, Massachusetts-based manufacturer said the FDA granted what is called accelerated approval for the shot, based on a smaller study showing it generated a stronger immune response compared with an existing high-dose vaccine for seniors, while it conducted 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 frequently than with current 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, signalling 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.
