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# Moderna RSV Vaccine Review Pushed Back
- URL: https://www.fdaweb.com/moderna-rsv-vaccine-review-pushed-back/
- Published: 2024-05-10T12:00:00.000Z
- Updated: 2026-09-14T14:30:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156958

FDA has told Moderna that it needs a couple more weeks to complete the review of its BLA for mRNA-1345, the company’s investigational respiratory syncytial virus vaccine, due to “administrative constraints.” The original user fee review action date was 5/12, and the agency now says it will conclude its review by the end of May.

Moderna says it remains on track for the vaccine to be reviewed at the CDC's Advisory Committee on Immunization Practices (ACIP) 6/26-27 meeting, which is necessary prior to commercial launch.