Biologics

FDA Refuses Filing of Moderna BLA for Flu Vaccine

FDA has issued Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the company’s use of a Priority Review Voucher intended to speed the process. The letter, signed by CBER director Vinay Prasad, cited the company’s choice of comparator in its pivotal efficacy study as the sole basis for the refusal, according to Moderna.

CBER reportedly objected to Moderna’s use of a licensed standard-dose seasonal influenza vaccine as the comparator, arguing that it did not reflect the “best-available standard of care” and therefore failed to meet requirements for an “adequate and well-controlled” study. Moderna says the letter did not identify any safety or efficacy concerns with mRNA-1010.

Moderna says the BLA is supported by two Phase 3 studies enrolling a total of 43,808 participants. One study compared the vaccine with a high-dose influenza vaccine in adults aged 65 and older, while the other assessed safety and relative efficacy against a standard-dose vaccine in adults aged 50 and older. Moderna said both trials met their primary endpoints and showed statistical superiority over the respective comparators.

In a statement, Moderna disputes FDA’s interpretation, saying neither the relevant regulation nor FDA guidance for seasonal influenza vaccines requires a comparator reflecting the “best-available standard of care.” The company also pointed to prior FDA feedback that appeared to endorse its trial design.

Moderna says that during a 4/2024 pre-Phase 3 consultation, CBER indicated it would be acceptable to use a licensed standard-dose influenza vaccine as the comparator, while recommending — but not requiring — the use of vaccines preferentially recommended for older adults in participants over 65. The agency did not raise objections to the study design or place the trial on clinical hold before the Phase 3 program began in 9/2024, the company says.

Following completion of the Phase 3 efficacy trial, which met all pre-specified primary endpoints, Moderna says it held a pre-submission meeting with CBER 8/2025. At that meeting, CBER requested additional supportive analyses related to the comparator and said the issue would be significant during the review, but did not signal that it would refuse to file the application, according to Moderna. The company says it included the requested analyses in its submission, including data from a separate Phase 3 study comparing mRNA-1010 with a licensed high-dose influenza vaccine.

“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna chief executive Stéphane Bancel says in the statement. He added that the company plans to engage with the agency to clarify the path forward, requesting a Type A meeting with CBER, the most expedited form of FDA meeting, to discuss the basis for the refusal.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome