The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is no longer administered under an emergency authorization.
Infants younger than 6 months old are too young to be vaccinated.
But the vaccine is only available for children with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, the FDA said, in line with a change made by Health and Human Services Secretary Robert F. Kennedy Jr.
“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,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.
Moderna said it expects to have its updated vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.
Doses of COVID shots from Moderna and Pfizer have been available to all kids regardless of risk. But Kennedy in May said the Department of Health and Human Services would no longer recommend the coronavirus vaccine for healthy pregnant women or healthy children.
Following his announcement, the Centers for Disease Control and Prevention recommended the vaccines based on “shared clinical decision-making” between parents and their children’s provider.
But the new licensing stipulation could make it harder for parents who want to get their healthy children vaccinated against COVID to do so, because that is now effectively an off-label use of the vaccine.
Leading medical groups led by the American Academy of Pediatrics earlier this week sued Kennedy over the new vaccine restrictions.
