() Moderna reports it has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax, in children 6 months through 11 years of age, who are at an increased risk of the disease.

The company announced the FDA’s full approval in a statement July 10, noting its COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under emergency use authorization. The company noted it expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Moderna CEO Stéphane Bancel celebrated the approval, writing, “COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” adding, “We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”

In May, Health and Human Services Secretary Robert F. Kennedy announced that the Centers for Disease Control and Prevention would no longer recommend “healthy” children and pregnant women receive the COVID-19 vaccine. On July 7, a lawsuit was filed in response to this decision by a coalition of doctors’ groups and public health organizations, including the American Academy of Pediatrics.