Moderna Says FDA Refusal to Review mRNA Flu Vaccine Contradicts Federal Rules, Prior Guidance - MedCity News

"Refuse-to-file letters inform a company that an application lacks information for the agency to conduct a review. While the issue may be resolved by submitting additional data, it can also mean the agency wants a company to conduct another clinical trial. Refuse-to-file letters are considered confidential communication between the FDA and a company, and are not typically made public. But Moderna took the unusual step of posting this letter to its website. It was signed by Vinayak Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER)."

""CBER does not consider the application to contain a trial 'adequate and well controlled' and the application is therefore, on its face, inadequate for review," Prasad wrote in the letter dated Feb. 3. "This is because your control arm does not reflect the best-available standard of care in the United States at the time of the study. I note that this determination is consistent with FDA's advice given to you prior to your study.""

Moderna's mRNA-1010 influenza vaccine succeeded in two pivotal Phase 3 clinical trials, but the FDA issued a refuse-to-file letter declining to review the application. The FDA did not identify safety or efficacy concerns but determined the submission lacked an adequate and well-controlled study because the control arm did not reflect the best-available U.S. standard of care. The letter was signed by Vinayak Prasad, director of CBER. Refuse-to-file letters indicate missing information for review, can require additional data or new trials, and are typically confidential; Moderna publicly posted the letter. The vaccine encodes hemagglutinin to trigger protective immune responses.

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