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2mo ago

FDA Approves Moderna’s mNEXSPIKE for Seniors and High-Risk Adults as CDC Drops Recommendations for Healthy Children and Pregnant Women

Moderna plans to roll out the shot ahead of the 2025–26 respiratory season

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 clearance, based on a randomized Phase 3 trial of over 11,400 participants, designates mNEXSPIKE for adults 65 and older and for 12- to 64-year-olds with CDC-defined risk factors.
  • In trial comparisons with Spikevax, mNEXSPIKE showed 9.3% higher relative efficacy in people 12 and older and a 13.5% boost in those aged 65 and above.
  • Unlike earlier mRNA vaccines, mNEXSPIKE can be stored at standard refrigerator temperatures, improving its logistical viability for broader distribution.
  • The CDC has removed routine COVID-19 vaccine recommendations for healthy children and pregnant women, though shared clinical decision-making remains an option.
  • This is the first COVID-19 shot approved under tightened FDA standards that mandate placebo-controlled studies and require Moderna to conduct post-market safety and efficacy trials.