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yesterday

FDA Approves Moderna’s Lower-Dose COVID-19 Vaccine for Older and At-Risk Individuals

The authorization follows updated federal rules focusing COVID-19 vaccination on adults 65 and older, with eligibility tied to underlying health risks.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File)
Food and Drug Administration commissioner Martin Markary speaks during an event in the Roosevelt Room at the White House, Monday, May 12, 2025, in Washington. (AP Photo/Mark Schiefelbein)
President Donald Trump, left, and Health and Human Services Secretary Robert F. Kennedy Jr. attend a Make America Healthy Again (MAHA) Commission Event in the East Room of the White House, Thursday, May 22, 2025, in Washington. (AP Photo/Jacquelyn Martin)
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Overview

  • The FDA cleared mNEXSPIKE (mRNA-1283) for adults 65 and older and those aged 12–64 with at least one CDC-defined risk factor under new COVID-19 vaccine guidelines.
  • A Phase 3 trial of roughly 11,400 participants showed mNEXSPIKE delivered 9.3% higher relative efficacy than Moderna’s original Spikevax in those 12 and older and 13.5% more in adults 65 and above.
  • Safety data indicated a similar systemic side-effect profile to Spikevax and fewer local reactions among mNEXSPIKE recipients.
  • The vaccine’s 10 µg dose—one-fifth the amount of Spikevax—targets the immune response more precisely and can be stored in standard refrigerators.
  • Moderna expects mNEXSPIKE to be available for the 2025–26 respiratory virus season in the U.S., and the product is under review in multiple international markets.