(NewsNation) — Moderna announces it has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax, for children aged six months to 11 years who are at an increased risk of the disease.
In a statement released on July 10, the company declared the FDA’s full approval, noting that its COVID-19 vaccine, mRNA-1273, was previously accessible to pediatric groups via emergency use authorization. Moderna expects to have the updated Spikevax ready for U.S. patients by the 2025-26 respiratory virus season.
Moderna’s CEO, Stéphane Bancel, expressed his satisfaction with the approval, stating, “COVID-19 remains a significant potential threat to children, particularly those with underlying health conditions. Vaccination is a crucial tool for protecting our youngest against severe illness and hospitalization.” He added, “We value the FDA’s thorough scientific evaluation and approval of Spikevax for pediatric groups at elevated risk for COVID-19 disease.”
In May, Health and Human Services Secretary Robert F. Kennedy announced that the Centers for Disease Control and Prevention would no longer recommend “healthy” children and pregnant women receive the COVID-19 vaccine. On July 7, a lawsuit was filed in response to this decision by a coalition of doctors’ groups and public health organizations, including the American Academy of Pediatrics.
