The Food and Drug Administration on Wednesday approved the first mRNA-based influenza vaccine, marking a milestone for the technology, which was first widely used during the COVID-19 pandemic.
The vaccine, developed by Moderna, is approved for adults ages 50 to 64 and those 65 and older, who face the highest risk of severe illness from the flu. Moderna said it expects the shot to be available for eligible patients during the 2026-27 flu season.
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“This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation,” Moderna CEO Stephane Bancel said.
Moderna said late-stage clinical trials found the vaccine was about 27% more effective than a standard flu shot in adults 50 and older. In a smaller study of adults 65 and older, the mRNA vaccine also generated a stronger immune response than an existing high-dose flu vaccine.
The company added that its mRNA platform allows vaccines to be produced in as little as two to three months after health officials select the season’s circulating flu strains, possibly speeding production compared with traditional flu shots.
Despite the FDA’s approval, the vaccine could still face obstacles before it reaches patients.
Health and Human Services Secretary Robert F. Kennedy Jr. has repeatedly criticized mRNA vaccine technology, calling COVID-19 vaccines “the deadliest vaccine ever made” and cutting nearly $500 million in federal funding for mRNA vaccine research.
Earlier this year, former FDA vaccine chief Vinay Prasad said the agency initially rejected Moderna’s application because the company compared its vaccine with a standard-dose flu shot in adults 65 and older instead of the higher-dose vaccine typically recommended for that age group. Moderna has said the FDA originally approved the trial’s design.
The rejection was unusual, and critics argued it reflected a more skeptical regulatory environment for mRNA vaccines under Kennedy’s leadership at HHS.
The vaccine’s path forward also remains uncertain.
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It still needs a recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which advises on vaccine use and insurance coverage. However, a federal judge has blocked the committee from meeting under its current membership.
Physicians could still prescribe the vaccine without an ACIP recommendation, but insurers may not be required to cover it, potentially limiting its uptake.
