FDA refuses Moderna mRNA flu vaccine software submitting for overview

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The U.S. Food and Drug Administration (FDA) refused to contemplate Moderna’s software for a brand new flu vaccine utilizing mRNA know-how, the corporate introduced Tuesday, a call that might delay the introduction of a shot designed to supply stronger safety for older adults.

Moderna stated it obtained what’s often called a "refusal-to-file" (RTF) letter from the FDA 's Middle for Biologics Analysis and Analysis (CBER), citing the shortage of an "ample and well-controlled" examine with a comparator arm that "doesn't replicate the best-available commonplace of care."

Stéphane Bancel, chief govt officer of Moderna, stated the FDA's choice didn't "determine any security or efficacy considerations with our product" and "doesn't additional our shared objective of enhancing America’s management in growing revolutionary medicines."

"It shouldn't be controversial to conduct a complete overview of a flu vaccine submission that makes use of an FDA-approved vaccine as a comparator in a examine that was mentioned and agreed on with CBER previous to beginning," Bancel stated in an announcement. "We look ahead to partaking with CBER to know the trail ahead as rapidly as doable in order that America's seniors, and people with underlying circumstances, proceed to have entry to American-made improvements."

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The FDA refused to overview Moderna’s software for a brand new mRNA-based flu vaccine, citing considerations in regards to the design of its late-stage medical trial. (iStock)

The uncommon choice from the FDA comes amid elevated scrutiny over vaccine approvals underneath Well being Secretary Robert F. Kennedy Jr. , who has criticized mRNA vaccines and rolled again sure COVID-19 shot suggestions over the previous 12 months.

Kennedy beforehand removed members of the federal authorities’s vaccine advisory panel and appointed new members, and moved to cancel $500 million in mRNA vaccine contracts.

The FDA licensed COVID-19 vaccines for the autumn for high-risk teams solely. Final Could, Kennedy introduced the vaccines could be faraway from the CDC’s routine immunization schedule for wholesome youngsters and pregnant ladies.

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The FDA’s refusal to overview Moderna’s mRNA flu vaccine comes amid broader vaccine coverage shifts underneath Well being Secretary Robert F. Kennedy Jr. (Jason Mendez/Getty Pictures)

In line with Moderna, the refusal-to-file choice was based mostly on the corporate’s alternative of comparator in its Part 3 trial — a licensed standard-dose seasonal flu vaccine — which the FDA stated didn't replicate the "best-available commonplace of care."

Moderna stated the choice contradicts prior written communications from the FDA, together with 2024 steering stating a standard-dose comparator could be acceptable, although a higher-dose vaccine was advisable for contributors over 65.

Moderna stated the FDA "didn't increase any objections or medical maintain feedback in regards to the adequacy of the Part 3 trial after the submission of the protocol in April 2024 or at any time earlier than the initiation of the examine in September 2024."

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Moderna stated it obtained a "refusal-to-file" letter from the FDA for its new mRNA flu vaccine, a transfer that might delay the shot’s rollout. (iStock)

In August 2025, following completion of the Part 3 efficacy trial, Moderna stated it held a pre-submission meeting with CBER , which requested that supportive analyses on the comparator be included within the submission and indicated the information could be a "vital difficulty throughout overview of your BLA."

Moderna stated it supplied the extra analyses requested by CBER in its submission, noting that "at no time within the pre-submission written suggestions or assembly did CBER point out that it will refuse to overview the file."

The corporate requested a Sort A gathering with CBER to know the idea for the RTF letter, including that regulatory evaluations are persevering with within the European Union, Canada and Australia.