The Food and Drug Administration has approved Moderna’s latest COVID-19 vaccine for adults 65 and older and for individuals aged 12 to 64 with at least one underlying condition that puts them at higher risk of severe illness.
First Approval Under New Standards
This marks the first COVID-19 vaccine approval since the FDA tightened its standards, requiring drugmakers to conduct more studies before approving updated vaccines for healthy adults under 65.
New Vaccine Restrictions
Under HHS Secretary Robert F. Kennedy Jr., regulators are now restricting COVID vaccines, including no longer recommending them for healthy children and pregnant women.
Moderna’s Statement
Moderna CEO Stéphane Bancel emphasized that COVID-19 remains a serious public health threat, with over 47,000 American deaths last year. He called the approval “an important new tool to help protect people at high risk of severe disease from COVID-19.”
New Vaccine Data and Availability
The vaccine, named mNEXSPIKE, is expected to be available for the 2025–2026 respiratory virus season. In a Phase 3 trial of approximately 11,400 participants, mNEXSPIKE demonstrated a 9.3% higher efficacy in those 12 and older and a 13.5% higher efficacy in adults 65 and older compared to the original Spikevax.
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