The U.S. Food and Drug Administration (FDA) has approved Moderna’s latest COVID-19 vaccine, mNEXSPIKE, for adults aged 65 and older, as well as individuals aged 12 to 64 with at least one underlying health condition. This marks the first vaccine approval since the FDA implemented stricter regulatory guidelines requiring placebo-controlled trials for healthy adults under 65.

mNEXSPIKE offers logistical advantages, including refrigerator storage, which enhances shelf life and facilitates distribution, particularly in developing countries. Clinical trials demonstrated that mNEXSPIKE is non-inferior—and in some cases superior—to Moderna’s original Spikevax vaccine in preventing COVID-19.

This approval comes amid a tightening of vaccine regulations under the Department of Health and Human Services, led by vaccine skeptic Robert F. Kennedy Jr. The FDA now mandates that COVID-19 booster shots for healthy individuals under 65 undergo randomized, placebo-controlled trials for approval, effectively limiting their availability to older adults and those at risk of severe illness.

The Centers for Disease Control and Prevention (CDC), also overseen by Kennedy, recently stated that COVID-19 vaccines remain an option for healthy children when parents and doctors agree on the need, countering earlier suggestions of removing the shots from the immunization schedule.

Moderna anticipates that mNEXSPIKE will be available for the 2025–2026 respiratory virus season, providing a crucial tool in protecting high-risk populations from COVID-19.