The Food and Drug Administration has approved the first messenger RNA-based vaccine for seasonal flu, after rejecting it earlier this year.
Moderna’s new seasonal flu vaccine using mRNA technology for people aged 50 and older, called mFLUSIVA, was approved, the drugmaker announced Wednesday.
The approval “reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation,” Moderna said in a statement. “We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible.”
mRNA vaccines teach cells to make a harmless spike protein that triggers an immune response, while traditional flu vaccines use inactive or weakened virus particles or viral proteins to train the immune system.
The FDA’s initial refusal came in February over trial comparator standards, but it agreed to review a revised application not long after.
The agency claimed the clinical trial did not use the best-available standard-of-care comparator for adults aged 65 and older. Moderna then met with federal regulators, adjusted its regulatory approach by age group, and submitted a revised plan.
Clearance for adults 65 and older was granted under accelerated approval, contingent on a post-marketing study that will run over two flu seasons. The FDA’s approval requires Moderna to run that additional trial in the older group as a condition of keeping the shot approved for that population.
This benchmark approval comes after heightened vaccine scrutiny was echoed among Trump administration officials.
Health and Human Services Secretary Robert F. Kennedy Jr. has criticized mRNA technology by claiming it poses greater risks than benefits and fails to stop upper respiratory infections like COVID-19 and influenza.
Acting on these views, the department cancelled roughly $500 million in federal mRNA vaccine research contracts, shifting funds toward traditional vaccine platforms.
Mr. Kennedy also ousted all members of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, replacing them with appointees who include prominent vaccine skeptics.
Former FDA vaccine chief Vinay Prasad left the agency at the end of April — officially the end of a planned one-year leave from his academic post — after a tenure marked by controversial vaccine and rare-disease drug decisions, including the initial refusal to review Moderna’s mRNA flu vaccine.
The administration has attempted to shift several standard childhood vaccines, including those for rotavirus, hepatitis A and B and influenza, into “high-risk” or restricted categories, shrinking universal recommendations.
President Trump signed executive orders directing health agencies to review and align policies with narrower schedules, which critics argue mimic talking points of foreign peer nations while ignoring domestic public health needs.
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