Moderna’s COVID Vaccine Wins FDA Approval for At-Risk Young Children

The FDA has granted full approval to Moderna’s COVID-19 vaccine, Spikevax, for children aged 6 months to 11 years who have at least one medical condition that puts them at higher risk for severe COVID-19 illness124.

This is the first COVID vaccine for children in the U.S. to receive full approval, rather than being administered under emergency use authorization14.

The approval applies exclusively to at-risk children; healthy children are not included in the approval and current CDC guidelines recommend shared clinical decision-making for their vaccination124.

Children aged 6 months to 23 months who have never been vaccinated need two shots one month apart, while those older than 2 or already vaccinated need just one shot14.

Moderna plans to have an updated version of the vaccine available ahead of the 2025-2026 respiratory virus season124.

Prominent health experts, including Drs. Makary and Prasad, have defended a vaccination framework focused on protecting high-risk groups rather than broadly vaccinating all children2.

Sources:

1. https://www.orthoatlanta.com/health-news/fda-fully-approves-modernas-covid-vaccine-for-some-young-kids

2. https://www.biopharmadive.com/news/modernas-covid-vaccine-spikevax-full-approval-children/752670/

4. https://www.statnews.com/2025/07/10/moderna-covid-spikevax-children-fda-approval/