FDA refuses Moderna mRNA flu vaccine application filing for review
NEWYou can now listen to Fox News articles!
The US Food and Drug Administration (FDA) declined to consider Moderna’s application for a new flu vaccine using mRNA technology; It’s a decision that could delay the rollout of a vaccine designed to provide stronger protection for older adults, the company said Tuesday.
Moderna said it received what is known as a “refusal to file” (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 comparator arm that “does not reflect the best available standard of care.”
Stéphane Bancel, Moderna’s CEO, said the FDA’s decision “does not identify any safety or efficacy concerns regarding our product” and “does not advance our shared goal of increasing America’s leadership in developing innovative medicines.”
“It should not be controversial to conduct a comprehensive review of an influenza vaccine rollout using 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. he said. “We look forward to collaborating with CBER to understand the path forward as quickly as possible so that America’s seniors and those with underlying conditions can continue to access American-made innovations.”
RFK JR. HE DEFENDED THE FIRE FRENZY AT CDC, HE DOES NOT EAT ‘NEW BLOOD’ AT THE AGENCY
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 rare decision comes amid increased scrutiny of vaccine approvals from Surgeon General Robert F. Kennedy Jr., who has criticized mRNA vaccines and reversed certain COVID-19 vaccine recommendations last year.
Kennedy previously dismissed and appointed new members of the federal government’s vaccine advisory panel and moved to cancel $500 million in mRNA vaccine contracts.
The FDA authorized COVID-19 vaccines in 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.
YOU BERNIE SANDERS CALLS RFK JR TO RESIGN AFTER LEAVE OF CDC OFFICIALS
The FDA’s refusal to review Moderna’s mRNA flu vaccine has been criticized by Surgeon General Robert F. Kennedy Jr. It comes amid broader vaccine policy changes under his administration. (Jason Mendez/Getty Images)
According to Moderna, the decision to reject the application was based on the company’s choice of comparator in the Phase 3 trial (licensed standard-dose seasonal flu vaccine); The FDA said this did not reflect the “best available standard of care.”
Moderna said the decision contradicted previous written communications from the FDA, including 2024 guidance that said a standard-dose comparator would be acceptable, but recommended a higher dose of the vaccine for participants over 65.
Moderna said the FDA “did not raise any objections or clinical comments regarding the adequacy of the Phase 3 trial at any time after protocol submission in April 2024 or prior to the start of the study in September 2024.”
RFK Jr LAUNCHED AN INVESTIGATION AT THE SCHOOL ALLEGEDLY VACCINATING THE CHILD WITHOUT PARENTAL PERMISSION
Moderna says it received a “refuse to file” letter from the FDA for its new mRNA flu vaccine; It’s a move that could delay the vaccine rollout. (iStock)
In August 2025, following completion of the Phase 3 efficacy trial, Moderna said it had a pre-submission meeting with CBER, requesting that supporting analyzes for the comparator be included in the submission and stating that the data would be a “significant issue during the review of your BLA.”
Moderna stated that it provided additional analyzes requested by CBER in its submission, but noted that “at no time in the pre-application written feedback or meeting did CBER indicate that it would decline to review the file.”
The company requested a Type A meeting with CBER to understand the basis for the RTF letter, adding that regulatory reviews were ongoing in the European Union, Canada and Australia.
CLICK TO DOWNLOAD FOX NEWS APPLICATION
Fox News has reached out to the Department of Health and Human Services for comment.
Alex Miller of Fox News Digital and The Associated Press contributed to this report.
