of US Food and Drug Administration The FDA has refused to consider Moderna Inc.’s application for a new influenza vaccine using mRNA technology, the company announced Tuesday, a decision that could delay the rollout of a vaccine aimed at providing more protection for older adults.
Moderna said it received a so-called “refusal to submit” (RTF) letter. F.D.A.The Center for Biologics Evaluation and Research (CBER) said there was a lack of “adequate and well-controlled” studies with comparator groups and “does not reflect the best available standard of care.”
Moderna CEO Stéphane Bancel said the FDA’s decision “does not identify any concerns regarding the safety or efficacy of our products” and “does not advance our shared goal of strengthening America’s leadership in the development of innovative medicines.”
“It is uncontroversial that we will conduct a comprehensive review of influenza vaccine applications using FDA-approved vaccines as comparators in studies that were discussed and agreed upon with CBER prior to initiation,” Bancel said in a statement. “We look forward to working with CBER to understand the path forward as soon as possible so that older Americans and people with underlying health conditions continue to have access to American-made innovation.”
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The unusual decision from the FDA comes amid increased scrutiny of vaccine approvals under the Surgeon General. Robert F. Kennedy Jr.He has criticized mRNA vaccines and retracted recommendations for certain COVID-19 vaccinations over the past year.
Kennedy used to expelled from federal parliament The government’s vaccine advisory committee has appointed new members and moved to cancel a $500 million mRNA vaccine contract.
The FDA authorized COVID-19 vaccines in the fall only for high-risk groups. Last May, President Kennedy announced that the vaccine would be removed from the CDC’s routine immunization schedule for healthy children and pregnant women.
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Moderna said its decision to deny the application was based on the comparator it chose in its Phase 3 trial (an approved standard-dose seasonal influenza vaccine), which the FDA said did not reflect the “best available standard of care.”
Moderna said the decision is inconsistent with prior written communication from the FDA, including guidance from 2024 that recommended higher doses of the vaccine for participants 65 and older but allowed standard-dose comparators.
Moderna said the FDA “has not submitted any objections or clinical pending comments regarding the appropriateness of the Phase 3 study at any time after the April 2024 protocol submission or prior to the September 2024 trial initiation.”
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In August 2025, after completion of the Phase 3 efficacy trial, Moderna will Pre-submission meeting with CBERcalled for supporting analysis on the comparator to be included in submissions and suggested that the data could be a “significant issue during the BLA’s review.”
Moderna said in its filing that it provided the additional analysis requested by CBER, and noted that “at no time in its written feedback or meetings prior to submission did CBER indicate that it refused 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.
Fox News is Ministry of Health and Human Services For comments.
Fox News Digital’s Alex Miller and The Associated Press contributed to this report.
