The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one underlying condition that puts them at high risk for severe outcomes from the disease.

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval to those with at least one underlying condition that puts them at risk for severe disease.

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.