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4d ago

FDA Approves Moderna’s Lower-Dose COVID-19 Booster for Seniors and High-Risk Individuals

The CDC has withdrawn routine vaccine recommendations for low-risk populations following federal tightening of booster eligibility rules.

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Not all children are eligible for the new Moderna COVID shots.
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A dose of COVID-19 vaccine from a vaccination clinic in the Kansas City area.

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.