Uncertainty Surrounds Moderna’s Next-Generation COVID Shot Amid Policy Changes

Moderna recently withdrew its FDA application for its next-generation combination flu/COVID-19 shot (mRNA-1083), after discussions with the agency about the need for additional efficacy data, pushing any potential approval to at least 20265.

The withdrawal is seen as a setback for Moderna, whose shares dropped 4.5% following the announcement, reflecting market uncertainty about the future of its latest vaccine candidate5.

The FDA has shifted its COVID-19 vaccine policy, now limiting routine vaccine access primarily to people 65 and older or those at high risk, and requiring vaccine makers to show benefit in younger and healthier populations through new clinical trials1.

Federal agencies are considering moving away from universal COVID-19 vaccination toward risk-based recommendations for the 2025–2026 season, focusing on older adults, people with underlying conditions, and other high-risk populations3.

Moderna's 2024-2025 COVID-19 vaccine formula is still authorized for children 6 months through 11 years, but the broader future of new formulations remains uncertain under the FDA’s tightened policies4.

Sources:

1. https://www.statnews.com/2025/05/20/fda-vaccine-framework-new-covid-shot-recommendations-vinay-prasad-marty-makary/

3. https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/05-Panagiotakopoulos-COVID-508.pdf

4. https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/moderna-covid-19-vaccine

5. https://www.biospace.com/fda/moderna-shares-fall-as-combo-flu-covid-19-vaccine-application-pulled