FDA refuses to review Moderna’s mRNA flu vaccine application

The U.S. Food and Drug Administration (FDA) refused to see Moderna’s exertion for a caller flu vaccine utilizing mRNA technology, the institution announced Tuesday, a determination that could hold the instauration of a changeable designed to connection stronger extortion for older adults.

Moderna said it received what’s known arsenic a "refusal-to-file" (RTF) missive from the FDA's Center for Biologics Evaluation and Research (CBER), citing the deficiency of an "adequate and well-controlled" survey with a comparator limb that "does not bespeak the best-available modular of care."

Stéphane Bancel, main enforcement serviceman of Moderna, said the FDA's determination did not "identify immoderate information oregon efficacy concerns with our product" and "does not further our shared extremity of enhancing America’s enactment successful processing innovative medicines."

"It should not beryllium arguable to behaviour a broad reappraisal of a flu vaccine submission that uses an FDA-approved vaccine arsenic a comparator successful a survey that was discussed and agreed connected with CBER anterior to starting," Bancel said successful a statement. "We look guardant to engaging with CBER to recognize the way guardant arsenic rapidly arsenic imaginable truthful that America's seniors, and those with underlying conditions, proceed to person entree to American-made innovations."

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The FDA refused to reappraisal Moderna’s exertion for a caller mRNA-based flu vaccine, citing concerns astir the plan of its late-stage objective trial. (iStock)

The uncommon determination from the FDA comes amid accrued scrutiny implicit vaccine approvals nether Health Secretary Robert F. Kennedy Jr., who has criticized mRNA vaccines and rolled backmost definite COVID-19 changeable recommendations implicit the past year.

Kennedy antecedently removed members of the national government’s vaccine advisory sheet and appointed caller members, and moved to cancel $500 cardinal successful mRNA vaccine contracts.

The FDA authorized COVID-19 vaccines for the autumn for high-risk groups only. Last May, Kennedy announced the vaccines would beryllium removed from the CDC’s regular immunization docket for steadfast children and large women.

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The FDA’s refusal to reappraisal Moderna’s mRNA flu vaccine comes amid broader vaccine argumentation shifts nether Health Secretary Robert F. Kennedy Jr. (Jason Mendez/Getty Images)

According to Moderna, the refusal-to-file determination was based connected the company’s prime of comparator successful its Phase 3 proceedings — a licensed standard-dose seasonal flu vaccine — which the FDA said did not bespeak the "best-available modular of care."

Moderna said the determination contradicts anterior written communications from the FDA, including 2024 guidance stating a standard-dose comparator would beryllium acceptable, though a higher-dose vaccine was recommended for participants implicit 65.

Moderna said the FDA "did not rise immoderate objections oregon objective clasp comments astir the adequacy of the Phase 3 proceedings aft the submission of the protocol successful April 2024 oregon astatine immoderate clip earlier the initiation of the survey successful September 2024."

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Moderna said it received a "refusal-to-file" missive from the FDA for its caller mRNA flu vaccine, a determination that could hold the shot’s rollout. (iStock)

In August 2025, pursuing completion of the Phase 3 efficacy trial, Moderna said it held a pre-submission gathering with CBER, which requested that supportive analyses connected the comparator beryllium included successful the submission and indicated the information would beryllium a "significant contented during reappraisal of your BLA."

Moderna said it provided the further analyses requested by CBER successful its submission, noting that "at nary clip successful the pre-submission written feedback oregon gathering did CBER bespeak that it would garbage to reappraisal the file."

The institution requested a Type A gathering with CBER to recognize the ground for the RTF letter, adding that regulatory reviews are continuing successful the European Union, Canada and Australia.

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Fox News has reached retired to the Department of Health and Human Services for comment.

Fox News Digital's Alex Miller and The Associated Press contributed to this report.