The U.S. Food and Drug Administration (FDA) has granted full approval for Moderna’s COVID-19 vaccine, Spikevax, for children aged 6 months to 11 years who are considered at increased risk of severe illness from the virus. The decision marks a shift from the vaccine’s previous emergency use authorization and opens the door for wider availability, though not without controversy.
The FDA’s approval makes Spikevax the first mRNA COVID vaccine fully licensed for younger children in the U.S., signaling regulatory confidence in its safety and efficacy for this vulnerable age group. However, the move comes amid an ongoing national debate over routine COVID-19 vaccinations for healthy children.
Health and Human Services Secretary Robert F. Kennedy Jr., a vocal critic of widespread childhood COVID vaccinations, has advocated for halting routine immunizations for kids not at risk. In contrast, the Centers for Disease Control and Prevention (CDC) continues to recommend the vaccine for children when parents and healthcare providers agree it’s appropriate.
“Vaccination remains an important tool for protecting children who are vulnerable to severe COVID-19 outcomes,” the CDC said in a statement. “Parents should consult with their child’s doctor to determine the best course of action.”
Following the announcement, Moderna’s stock rose by 2%, reflecting investor confidence as the company gears up for its next vaccine rollout for the 2025-2026 respiratory virus season. Moderna has indicated it is expanding production and outreach in anticipation of fall demand.
