The Food and Drug Administration (FDA) has granted full approval to Moderna’s COVID-19 vaccine for young children—but only for those with underlying health conditions that put them at greater risk of severe illness—prompting sharp criticism from President Donald Trump’s MAGA base.
The decision makes Moderna’s Spikevax the first pediatric COVID vaccine to receive full authorization in the United States, but the approval is notably limited in scope.
The announcement follows a broader shift in vaccine policy under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
Earlier this year, he ended federal recommendations for routine COVID-19 vaccination of healthy children and pregnant women, citing updated data and revised risk assessments, as previously reported by Resist the Mainstream.
Moderna confirmed Thursday that the FDA had approved a supplemental application for Spikevax, extending full licensure to children between six months and 11 years old with qualifying health conditions.
Spikevax has already been fully approved for individuals 12 and older since 2022.
The company also noted that an updated formulation will be available ahead of the 2025–26 respiratory virus season.
Current guidance calls for two doses for unvaccinated children aged six to 23 months and a single dose for older children or