Why did the FDA refuse to review Moderna's new mRNA flu shot?

The FDA refused to review Moderna's new mRNA flu shot because the clinical trials compared it to standard flu shots instead of vaccines for high-risk individuals, which the FDA deemed not to reflect the best available standard of care.

What are the implications of the FDA's decision on Moderna's flu vaccine?

The FDA's decision to refuse review could have implications for all new and updated vaccines in the US, potentially affecting future approval processes.

Has Moderna's mRNA flu vaccine been approved in other countries?

Yes, Moderna's licensing application for the new mRNA flu vaccine is already under review in the European Union, Canada, and Australia.

Home / Health / FDA Rejects Moderna Flu Shot Review, Citing Trial Standards

FDA Rejects Moderna Flu Shot Review, Citing Trial Standards

11 Feb

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Summary

FDA refused to review Moderna's new mRNA flu shot application.
The refusal was based on trial comparisons, not safety or efficacy.
This decision could impact future US vaccine approvals and updates.

FDA Rejects Moderna Flu Shot Review, Citing Trial Standards

The U.S. Food and Drug Administration (FDA) has declined to review Moderna's application for a new messenger RNA (mRNA) flu vaccine. This decision, which could set a precedent for other new and updated vaccines, stems from the clinical trials comparing Moderna's shot to standard flu vaccines rather than those targeting high-risk populations. While the vaccine demonstrated effective antibody responses and no safety issues in trials, the FDA stated the comparison did not meet their standard for an "adequate and well-controlled" study.

Moderna has requested a meeting with the FDA to discuss the refusal, emphasizing that the trial design was previously discussed and agreed upon with the Center for Biologics Evaluation and Research (CBER). The company highlighted that the licensing applications for this vaccine are already under review in the European Union, Canada, and Australia. This development occurs amid broader policy discussions and shifts in vaccine recommendations by the U.S. Department of Health and Human Services.