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FDA approves Moderna’s new lower-dose COVID-19 vaccine

  • The FDA approved Moderna's new COVID-19 vaccine, mNexspike, late Friday for adults 65 and older and high-risk people ages 12 to 64.
  • This approval follows a clinical trial of 11,400 people comparing mNexspike with Moderna's existing vaccine, and introduces new FDA limits on who can use it.
  • MNexspike uses a dose one-fifth the size of Spikevax, Moderna's current vaccine, and targets the immune response more precisely as a next-generation option.
  • Moderna CEO Stéphane Bancel stated that the FDA's authorization of their third vaccine, mNEXSPIKE, provides a valuable option aimed at safeguarding individuals most vulnerable to severe COVID-19 illness.
  • Because of the FDA restrictions, mNexspike will supplement rather than replace Spikevax, suggesting a more targeted approach to vaccine use in high-risk groups.
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Folha de S.Paulo broke the news in São Paulo, Brazil on Saturday, May 31, 2025.
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