
Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its Spikevax (mRNA-1273) COVID vaccine for children 6 months to 11 years old. But, because federal officials in May restricted its recommendations for COVID-19 vaccines to adults 65 and older and to people of all ages who are at increased risk for severe disease, Spikevax will be available only to kids in that age range who are at higher risk.
"COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization," said Moderna CEO Stéphane Bancel, MBA, MEng. "We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease."
Doses will be available this fall
"Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season," the Moderna news release states.
Spikevax first received full FDA approval in January 2022 in adults after being available on an emergency use basis earlier in the pandemic. Last year the FDA expanded the approval to people 12 years and older.
Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.
On May 31 the FDA approved Moderna's next-generation mRNA COVID vaccine, called mNexspike (mRNA-1283). It targets a portion of the SARS-CoV-2 spike protein for virus neutralization, allowing for a dose that's one fifth the size of Spikevax. It will be available for the upcoming 2025-26 respiratory virus season to seniors and those 12 to 64 years who are at risk of severe COVID-19.
Both vaccines are based on JN.1 lineage strains, which in May the FDA approved for use this coming season.