Overview
- The FDA authorized mNEXSPIKE on June 1 for adults 65 and older and those ages 12–64 with underlying health conditions under its May policy shift.
- Moderna’s next-generation booster contains one-fifth the mRNA dose of its original Spikevax shot and surpassed it in antibody response with fewer local reactions in trials.
- The company plans to roll out mNEXSPIKE for the 2025–26 respiratory virus season and will update its primary vaccine to target the LP.8.1 variant this fall.
- Under HHS Secretary Robert F. Kennedy Jr., the FDA now requires placebo-controlled trials to approve boosters for healthy adults under 65.
- Despite dropping routine guidance, the CDC still recommends shared decision-making for parents considering COVID-19 vaccination of young children.