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If approved, a new seasonal flu shot would become the first commercially available flu vaccine using mRNA technology, according to a news release. Moderna’s seasonal influenza vaccine mRNA-1010 (marketed as mFlusiva) has not yet received final Food and Drug Administration (FDA) approval, but it has reached a major milestone. On June 18, the agency’s vaccine committee voted unanimously that the mRNA vaccine’s benefits outweigh its risks for adults aged 50 years and older, as published in a phase 3 trial presented in the New England Journal of Medicine. The study shows mRNA-1010 reduced flu cases by about 27% compared with another common flu vaccine. The FDA’s final decision is expected by early August. Initially, the agency had declined to review the vaccine because of its concerns with the trial design but later changed course. mRNA-1010 has also been accepted for regulatory review in the European Union, Canada, and Australia.
Rapid response: Current flu vaccine formulations must be produced months before respiratory virus season, based on predictions of which virus strains are expected to circulate during the season. An mRNA platform could potentially allow manufacturers to update vaccine strains closer to flu season for better matches.
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