Overview

• The FDA granted full approval on July 10 to Spikevax for children aged six months to 11 years with underlying health conditions, converting it from emergency use to a biologics license.
• The approval aligns with Health Secretary Robert F. Kennedy Jr’s late-May directive that removed COVID-19 vaccine recommendations for healthy minors and pregnant women.
• Doctors’ groups and public health organizations led by the American Academy of Pediatrics sued the federal government on July 7 over the narrowed vaccine guidance.
• The CDC continues to advise that COVID-19 vaccination remains an option for healthy children through shared clinical decision-making between parents and providers.
• Moderna expects its updated Spikevax formulation targeting new variants to be available for the 2025–26 respiratory virus season.