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The U.S. Food and Drug Administration (FDA) declined to consider Moderna’s application for a new flu vaccine that uses mRNA technology, the company announced Tuesday, a decision that could delay the introduction of a shot designed to offer greater protection to older adults.
Moderna said it received what is known as a “refusal to submit” (RTF) letter from the FDA’s Center for Biologics Evaluation and Research (CBER), citing the lack of an “adequate and well-controlled” study with a comparison group that “does not reflect the best available standard of care.”
Stéphane Bancel, Moderna’s chief executive, said the FDA’s decision did not “identify any safety or efficacy issues with our product” and “does not advance our shared goal of enhancing America’s leadership in the development of innovative medicines.”
“It should not be controversial to conduct a comprehensive review of a flu vaccine presentation that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed upon with CBER before it began,” Bancel said in a statement. “We look forward to collaborating with CBER to understand the path forward as quickly as possible so that older Americans and those with underlying conditions continue to have access to American-made innovations.”
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The FDA declined to review Moderna’s application for a new mRNA-based flu vaccine, citing concerns about the design of its late-stage clinical trial. (iStock)
The FDA’s unusual decision comes amid increased scrutiny over vaccine approvals under Health Secretary Robert F. Kennedy Jr., who criticized mRNA vaccines and reversed certain COVID-19 vaccine recommendations over the past year.
Kennedy previously removed members of the federal government’s vaccine advisory panel and appointed new members, and moved to cancel $500 million in mRNA vaccine contracts.
The FDA authorized COVID-19 vaccines for the fall only for high-risk groups. Last May, Kennedy announced that the vaccines would be removed from the CDC’s routine immunization schedule for healthy children and pregnant women.
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The FDA’s refusal to review Moderna’s mRNA flu vaccine comes amid broader vaccine policy changes under Health Secretary Robert F. Kennedy Jr. (Jason Mendez/Getty Images)
According to Moderna, the decision to decline to apply was based on the company’s choice of comparator in its Phase 3 trial (an authorized standard-dose seasonal flu vaccine) which the FDA said did not reflect the “best available standard of care.”
Moderna said the decision contradicts previous written communications from the FDA, including guidance for 2024 that a standard dose comparator would be acceptable, although a higher-dose vaccine was recommended for participants over 65.
Moderna said the FDA “did not raise any objections or clinical hold comments on the appropriateness of the Phase 3 trial after protocol submission in April 2024 or at any time prior to the start of the study in September 2024.”
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Moderna said it received a “refusal to submit an application” letter from the FDA for its new mRNA flu vaccine, a move that could delay the vaccine’s rollout. (iStock)
In August 2025, following the completion of the Phase 3 efficacy trial, Moderna said it held a pre-submission meeting with the CBER, in which it requested that comparator supporting analyzes be included in the submission and indicated that the data would be a “major issue during the review of its BLA.”
Moderna said it provided the additional analyzes requested by CBER in its filing, noting that “at no time during the meeting or written comments prior to the filing did CBER indicate that it would decline to review the file.”
The company requested a Type A meeting with CBER to understand the rationale for the RTF letter, adding that regulatory reviews continue in the European Union, Canada and Australia.
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Fox News has reached out to the Department of Health and Human Services for comment.
Fox News Digital’s Alex Miller and The Associated Press contributed to this report.