Overview

• The FDA authorized Moderna’s mNEXSPIKE vaccine for adults aged 65 and older and for individuals aged 12 to 64 with at least one underlying condition that increases COVID-19 risk.
• Authorization was based on a randomized, observer-blind Phase 3 trial of roughly 11,400 participants that showed mild, short-lived side effects and no vaccine-linked serious adverse events.
• Moderna expects mNEXSPIKE to be ready for the 2025-2026 respiratory virus season to bolster protection for high-risk populations.
• Representative Marjorie Taylor Greene and other MAGA figures denounced the decision on social media, with some calling for the FDA’s abolition.
• The CDC has updated its immunization schedule to remove routine COVID-19 vaccine recommendations for healthy children and pregnant women.