Washington, D.C. —— The U.S. Food and Drug Administration (FDA) has officially approved Moderna’s latest COVID-19 vaccine, mNEXSPIKE, marking a major step in the country’s evolving pandemic response strategy. The shot is authorized for adults aged 65 and older, as well as individuals aged 12 to 64 with underlying health conditions that increase the risk of severe COVID-19.
This marks the first FDA approval of a next-generation COVID vaccine since the agency tightened vaccine approval rules earlier this year, requiring manufacturers to conduct placebo-controlled trials for healthy adults under 65. The updated guidance also limits general-use recommendations, aligning with new health policies under Health and Human Services Secretary Robert F. Kennedy Jr.
Key Details on the New Vaccine
- Name: mNEXSPIKE
- Manufacturer: Moderna
- Availability: Expected for the 2025–2026 respiratory virus season
- Target groups:
- All adults aged 65 and older
- Individuals 12–64 with CDC-defined risk factors (e.g., diabetes, heart disease, obesity, etc.)
Moderna said its late-stage trial of over 11,000 participants demonstrated a 13.5% higher efficacy in adults 65 and older compared to the original Spikevax vaccine, and a 9.3% improvement among those 12 and older. The new shot can also be stored in refrigerators instead of freezers, simplifying distribution logistics — especially in remote and underserved areas.
Changing U.S. Vaccine Policy
The Biden administration’s COVID-19 vaccine policy has shifted under the leadership of Secretary Kennedy, who has publicly advocated stricter vaccine oversight. While the CDC now stops short of recommending COVID shots for healthy children and pregnant women, it allows parents and doctors to make case-by-case decisions.
Despite controversy surrounding Kennedy’s stance, the FDA emphasized that 100 to 200 million Americans will remain eligible for annual COVID boosters under current guidelines.
Moderna Responds to Waning Demand
With demand for its original Spikevax declining, Moderna is banking on mNEXSPIKE and other mRNA-based vaccines to sustain its vaccine business. The company also recently withdrew its flu-COVID combo shot application to await further data.
“This approval adds an important new tool to help protect people at high risk of severe disease,” said Moderna CEO Stéphane Bancel. “COVID-19 remains a public health threat, with over 47,000 deaths in the U.S. last year alone.”
The approval of mNEXSPIKE comes amid broader restructuring at the Department of Health and Human Services, where ongoing workforce cuts have raised questions about future regulatory capacity. Still, public health experts say having an updated, more effective vaccine available for vulnerable Americans could help reduce hospitalizations this fall and winter.