The FDA approved a new Moderna COVID-19 vaccine aimed at children aged 6 months to 11 years old. The vaccine was previously available under an Emergency Use Authorization (EUA).
“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,” Moderna CEO Stéphane Bancel said in a statement. “We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”
The vaccine is expected to be available for the 2025-2026 respiratory virus season.
The vaccine’s approval comes as the FDA previously requested that Moderna, as well as BioNTech, expand the warning labels to include notes of heart inflammation. The letters, made public on May 21, were dated April 17 and urged the vaccine developers to add, “Following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines, the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age” to the label.
In May, the FDA approved a COVID-19 vaccine from Novavax, designed for those aged 65 and older and for those aged 12 to 64 with underlying health conditions.
While the FDA has approved new vaccines, the CDC pulled its recommendation that healthy children and pregnant women receive the COVID-19 vaccine. The move was celebrated by HHS Secretary Robert F. Kennedy Jr., who said there was a “lack of any clinical data to support the repeat booster strategy in children.”
