The U.S. Food and Drug Administration has granted approval for mFlusiva, a groundbreaking seasonal influenza vaccine developed by Moderna that employs messenger RNA technology. The vaccine is authorized for individuals aged 50 and older, marking the first time an mRNA-based flu shot has received FDA clearance. An advisory committee unanimously determined the vaccine demonstrates both safety and effectiveness in preventing seasonal influenza illness.
Unlike traditional flu vaccines that require months to manufacture, mFlusiva leverages mRNA technology to instruct the body’s cells to produce hemagglutinin, a protein found on influenza virus surfaces. This rapid production capability allows the vaccine to better match circulating flu strains each season. Clinical trials involving over 40,000 participants demonstrated that the mRNA vaccine provided 26.6% greater protection against infection compared to conventional vaccines. Among participants aged 65 and older, protection increased to 27.4%. While recipients experienced more frequent side effects such as injection-site pain and fatigue, these effects were generally mild and temporary.
The approval represents a notable development given the current political climate surrounding mRNA therapeutics. The federal government has recently withdrawn hundreds of millions in funding for mRNA research, and some administration officials have publicly opposed the technology. Moderna’s initial application faced an unexpected rejection before the FDA reversed course one week later, with experts uncertain about the reasoning behind this decision.
Originally reported by Livescience →
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