The FDA's Center for Biologics Evaluation Research (CBER) refused to review Moderna's mRNA flu vaccine application (mRNA-1010) due to the phase 3 trial using a standard-dose flu vaccine as comparator instead of the 'best-available standard of care' for adults 50+, particularly high-dose for seniors.13
Moderna noted the FDA had previously agreed to the trial design in 2024, with no safety or efficacy concerns identified, and the vaccine is under review in the EU, Canada, and Australia.12
This refusal is described as part of a pattern of FDA reversing positions on approval evidence, affecting other companies like Sarepta, Capricor, and Atara Biotherapeutics.3
Critics, including Moderna executives and experts like Paul Offit and Peter Hotez, argue it undermines FDA confidence, chills vaccine investment, and impacts US biosecurity.14
HHS under Secretary Robert F. Kennedy Jr. shows skepticism toward mRNA technology, amid broader policy shifts.12
Sources:
1. https://www.cidrap.umn.edu/influenza-vaccines/fda-reverses-course-refuses-review-moderna-s-application-new-mrna-flu-vaccine
2. https://www.youtube.com/watch?v=Q4g5WTq1qKU
3. https://www.biospace.com/fda/modernas-outright-flu-refusal-just-the-latest-case-of-crossed-fda-signals
4. https://www.statnews.com/2026/02/12/fda-moderna-rejection-upends-vaccine-industry/