Moderna's COVID-19 Vaccine Receives Full FDA Approval for Children with Medical Conditions

Strategic Insights -

COVID-19 continues to pose a significant threat to children, especially those with underlying medical conditions. The U.S. Food and Drug Administration (FDA) has granted full approval to Moderna's COVID-19 vaccine, Spikevax, for use in children with medical conditions that put them at higher risk of severe illness. This move makes Spikevax the first COVID shot for kids in the U.S. to be fully approved, rather than used under emergency authorization. The vaccine can now be given to children ages 6 months through 11 years, but only if they have at least one health issue that increases their COVID risk.

Key Takeaways:

  • Moderna's COVID-19 vaccine, Spikevax, has received full approval from the FDA for use in children with medical conditions that put them at higher risk of severe illness.
  • The vaccine is approved for children ages 6 months through 11 years, but only if they have at least one health issue that increases their COVID risk.
  • COVID-19 continues to pose a significant threat to children, especially those with underlying medical conditions, and vaccination can be an important tool for protecting them against severe disease and hospitalization.
  • Previously, Moderna's vaccine was already fully approved for people 12 and older.
  • Moderna expects to have an updated version of the vaccine ready for the 2025-26 virus season.
  • Children ages 6 months to 23 months who have never been vaccinated need two shots, a month apart, while kids older than 2, or those who have already been vaccinated, should get one shot.
  • A CDC group had planned to revise recommendations to encourage COVID vaccination for kids under 2, but that work stopped when the CDC's vaccine committee was fired.

Statistics:

  • More than half of the children hospitalized for COVID are less than two years old, and most of them do not have an underlying medical condition.
  • Babies under 6 months of age have the second-highest rate of hospitalization for COVID after adults 75 and older.
  • Children aged 6-11 years have a hospitalization rate similar to adults aged 50-64.
  • The FDA's new limits on the vaccine's use may make it harder for parents who want to vaccinate their babies, and some doctors may hesitate to give the vaccine to healthy kids if it's not officially approved for them.

Sources:

  • STAT News, July 10, 2025
  • CDC data on hospitalization rates for COVID in children
  • Moderna's press release on Spikevax's FDA approval