The US Food and Drug Administration (FDA) has given full approval to Moderna’s Covid-19 vaccine for children aged 6 months to 11 years. However, the approval comes with a restriction: it is only for use in children who have at least one medical condition that puts them at increased risk of severe illness from Covid.
Moderna CEO Stéphane Bancel said vaccination can be an important tool for protecting children against severe disease and hospitalization. The company expects to have its updated vaccine available for the 2025-26 respiratory virus season.
Children aged 6 months to 23 months who have never been vaccinated need two shots, spaced one month apart. Older children or those previously vaccinated should get a single shot. Experts, including former CDC medical epidemiologist Fiona Havers, warn that young age itself is a risk factor for severe Covid infections, which can lead to hospitalization.
The FDA’s decision limits vaccine eligibility and may leave parents with fewer choices for protecting their babies from severe Covid.
Source: https://www.statnews.com/2025/07/10/moderna-covid-spikevax-children-fda-approval