FDA will review Moderna's mRNA-based flu shot

The FDA reversed an earlier refusal and agreed to review Moderna's application for an mRNA-based influenza vaccine, with a target decision date of Aug. 5.

The Food and Drug Administration has reversed a prior decision and agreed to review Moderna's application for the company's mRNA-based influenza vaccine under a revised approach. Last week the agency had declined to review the application, saying the submission did not include an adequate and well-controlled study for older adults. Moderna proposed splitting its request, seeking full approval for adults 50 to 64 and accelerated approval for adults 65 and older while committing to further study in the older group. The company set a target date of Aug. 5 for completing the review and said the vaccine could be available for the next flu season if approved. Key facts: - The FDA agreed to advance Moderna's application for review after previously declining to do so. - The agency's earlier refusal cited a lack of an "adequate and well-controlled" study and questioned the use of dose comparisons for adults 65 and older. - Moderna proposed full approval for ages 50–64 and accelerated approval for ages 65+, with a requirement to study the vaccine further in older adults. - Moderna reported a target date of Aug. 5 to complete the FDA review and said the vaccine could reach the market for the next flu season if approved. - The article notes that Health Secretary Robert F. Kennedy Jr. and other administration officials have criticized mRNA use for respiratory vaccines and have reduced federal funding for mRNA research. Summary: The FDA's reversal restarts the formal regulatory review of Moderna's mRNA flu vaccine and sets an Aug. 5 target for a decision. Moderna's split-approval approach is intended to allow consideration for adults 50–64 while requiring additional study among older adults. The ultimate outcome will depend on the agency's review and any subsequent data requirements.