FDA Approves Moderna's Next-Gen COVID-19 Vaccine with Limitations
The U.S. Food and Drug Administration (FDA) has granted approval to Moderna's next-generation COVID-19 vaccine, mNEXSPIKE, albeit with significant usage restrictions. This development marks a pivotal moment in the evolving landscape of coronavirus vaccinations and reflects recent changes in regulatory approaches.
Approval Details and Restrictions
Moderna announced on May 31, 2025, that mNEXSPIKE has been approved for use in two specific populations:
- Adults aged 65 and older
- Individuals between 12 and 64 years old with one or more risk factors for severe COVID-19, such as asthma, diabetes, or COPD
The approval comes after a Phase 3 study involving 11,400 participants, which demonstrated mNEXSPIKE's non-inferiority to Moderna's original vaccine, Spikevax. The trial showed a 9.3% higher relative vaccine efficacy in participants 12 and older, with an even more pronounced 13.5% improvement in those 65 and older.
Regulatory Landscape and Policy Shifts
The approval of mNEXSPIKE arrives amid significant changes in the FDA's approach to COVID-19 vaccines. FDA Commissioner Marty Makary, M.D., and Center for Biologics Evaluation and Research head Vinay Prasad, M.D., recently outlined new guidelines in The New England Journal of Medicine. These guidelines stipulate that for healthy individuals aged six months to 64 years, vaccine developers must now produce "randomized, controlled trial data evaluating clinical outcomes" before approval.
For older adults and those with risk factors, immunogenicity data demonstrating antibody production can support approvals. This policy shift represents a departure from the previous "one-size-fits-all" approach to COVID-19 vaccine approvals.
Industry Implications and Future Outlook
Moderna expects to make mNEXSPIKE available for the 2025-2026 respiratory virus season in the U.S. The vaccine is currently targeted to the JN.1 coronavirus variant, reflecting ongoing efforts to adapt to evolving strains of the virus.
While the approval is seen as a positive development for Moderna, industry analysts, such as Jefferies' Michael Yee, note that there's still some risk to the company's sales guidance due to persistently low vaccination rates.
As the pharmaceutical industry continues to navigate the complex landscape of COVID-19 vaccine development and regulation, the approval of mNEXSPIKE with its specific limitations may set a precedent for future vaccine authorizations. The upcoming CDC advisory committee meeting in late June is expected to further shape recommendations for COVID-19 vaccine use in the coming fall and winter seasons.
References
- Moderna's next-gen COVID shot gets FDA backing with some limitations
Moderna has picked up its third FDA approval with the agency's endorsement of mNEXSPIKE. The approval covers the vaccine's use in people 65 and older and those ages 12 to 64 with risk factors for severe COVID.
- FDA clears Moderna’s new COVID vaccine, but with limits
The shot, dubbed mNexspike, is approved for older adults and people whose health conditions put them at higher risk of severe disease.
Explore Further
What were the specific results of the Phase 3 study that led to the approval of mNEXSPIKE?
What are the primary differences between Moderna's mNEXSPIKE and its original Spikevax vaccine in terms of composition or target variants?
How do the new FDA guidelines outlined by Dr. Marty Makary and Dr. Vinay Prasad affect the approval process for future COVID-19 vaccines?
What challenges might Moderna face in achieving sales targets for mNEXSPIKE amid low vaccination rates?
How does mNEXSPIKE's targeting of the JN.1 variant compare with other COVID-19 vaccines currently in development or on the market?