The United States Food and Drug Administration (FDA) has approved the Moderna COVID vaccine for high-risk children under 12. 0 minutes ago. Vaccine manufacturer Moderna announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to the Spikevax (mRNA-1273) COVID vaccine for children ages 6 months to 11 years.
Vaccine manufacturer Moderna announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to the Spikevax (mRNA-1273) COVID vaccine for children ages 6 months to 11 years. However, because federal officials limited COVID-19 vaccine recommendations in May to adults 65 and older and people of all ages at high risk for severe disease, Spikevax will only be available to children in this age range and those at high risk.
“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool to protect our youngest children from severe illness and hospitalization,” said Moderna CEO Stéphane Bancel (MBA, MEng). “We commend the FDA’s rigorous scientific review and approval of Spikevax for pediatric populations at high risk of COVID-19 disease.”
Doses will be available this fall
“Moderna expects the updated Spikevax vaccine to be available to eligible populations in the U.S. for the 2025-2026 respiratory virus season,” a Moderna press release states.
After being available for emergency use early in the pandemic, Spikevax received full FDA approval for adults in January 2022. Last year, the FDA expanded the approval to people ages 12 and older.
Moderna expects its updated Spikevax vaccine to be available to eligible populations in the US for the 2025-2026 respiratory virus season.
On May 31, the FDA approved Moderna’s next-generation mRNA COVID vaccine, called mNexspike (mRNA-1283). This vaccine targets a portion of the SARS-CoV-2 spike protein for virus neutralization, allowing for a dose one-fifth the size of Spikevax. It will be available for the elderly and those aged 12-64 at risk for severe COVID-19 for the 2025-26 respiratory virus season.
Source: Musitem Haber
