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yesterday

FDA approves Moderna’s mNEXSPIKE vaccine for seniors and high-risk Americans

Phase 3 data showed the new booster provided stronger protection than Moderna’s original shot, with distribution set for the 2025–2026 respiratory season.

A Moderna COVID-19 vaccine fills a syringe at Borinquen Health Care Center on in Miami. Photo illustration: Joe Raedle/ Getty Images
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Overview

  • The FDA cleared mNEXSPIKE for adults 65 and older and for those aged 12–64 with at least one CDC-defined risk factor.
  • A Phase 3 trial of about 11,400 participants found mNEXSPIKE achieved 9.3% higher relative efficacy versus mRNA-1273 and 13.5% greater efficacy in adults over 65.
  • Moderna reports mNEXSPIKE has a safety profile similar to its original vaccine, with fewer local reactions and common side effects such as injection site pain, fatigue, headache and myalgia.
  • Designed as a booster for individuals previously vaccinated against COVID-19, mNEXSPIKE will join Spikevax and mRESVIA in Moderna’s respiratory vaccine lineup.
  • Moderna aims to roll out mNEXSPIKE in the U.S. for the 2025–2026 respiratory virus season as COVID-19 continues to pose a serious threat following over 47,000 U.S. deaths in 2024.