Moderna Spikevax gets full USFDA nod for kids 6 months through 11 years at increased COVID risk
Cambridge: Moderna has received approval from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics License Application (sBLA) for Spikevax, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA).
"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 Stéphane Bancel, Chief Executive Officer of Moderna. "We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease."
Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine to protect you against COVID-19. SPIKEVAX is for people who are 65 years of age and older, or 6 months through 64 years of age at high risk for severe COVID-19.
Vaccination with SPIKEVAX may not protect all people who receive the vaccine.
Read also: FDA approves season's updated mRNA COVID vaccines for protection against current variants
Spikevax is a registered trademark of Moderna.
The originally authorised Spikevax contains elasomeran, a molecule called messenger RNA (mRNA) with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.
