FDA Approves Moderna Low-Dose COVID Vaccine for Older, High-Risk Adults

The U.S. Food and Drug Administration has approved Moderna's new COVID-19 vaccine, mNEXSPIKE, designed specifically for adults 65 and older and individuals aged 12 to 64 with underlying health conditions that increase their risk of severe COVID-19. Unlike Moderna's original Spikevax vaccine, mNEXSPIKE uses a refined immune target allowing it to be administered at a lower dose—one-fifth that of Spikevax—while demonstrating equal or superior safety and efficacy in clinical trials involving over 11,000 participants. This approval marks a strategic shift toward targeting vaccines to high-risk populations rather than universal eligibility, aligning with similar FDA restrictions on Novavax's next-generation vaccine. Moderna plans to offer both vaccines in the upcoming respiratory virus season, providing additional options for COVID-19 protection amid ongoing public health concerns. The vaccine's approval followed comprehensive studies showing improved relative efficacy, particularly among older adults, with common side effects including injection site pain and fatigue. This development comes amid changes in federal vaccine policy and funding priorities, reflecting evolving approaches to pandemic management.