The FDA approved Moderna’s COVID-19 vaccine, Spikevax, in children between the ages of 6 months and 11 years who are at increased risk for COVID-19 disease.
Spikevax is already indicated for people between 12 and 64 years of age who are at increased risk, and for those who are 65 and older. Previously, Moderna’s COVID-19 vaccine mRNA-1273 was available for children under an emergency use authorization.
Although COVID-19 has lessened since the height of the pandemic, it continues to be a threat to the general public, especially to those who have comorbidities. The CDC estimates from Oct. 1, 2024, through June 7, 2025, COVID-19 caused an estimated 9.8 million to 16.1 million illnesses and 32,000 to 51,000 deaths. Although pediatric cases are only a smaller portion of that, they are not zero. Among pediatric deaths, 29 children aged 5 to 17 years died from COVID-19 between July 2024 and June 2025; 16 children 24 months to 4 years died; and 45 children younger than 24 months died from COVID-19. “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, MSc, MEng, MBA, the CEO of Moderna, in a press statement.
Adverse events related to the vaccine include allergic reactions, such as trouble breathing, swelling of the face and throat, a fast heartbeat, rash, dizziness, and weakness. Myocarditis and pericarditis have occurred in some people who have received mRNA COVID-19 vaccines, and have occurred most commonly in males 12 through 24 years of age. For more information, see the full prescribing information.
The Spikevax vaccine should be available in the United States for the 2025-2026 respiratory virus season, according to Moderna.
Based on a press release.