FDA Grants Full Approval to Modernas COVID-19 Vaccine for Children

Published: Friday, July 11, 2025 at 9:08 am

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

Moderna has received full approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, Spikevax, for children aged six months to 11 years who are at an increased risk of the disease. The company announced the approval in a statement, highlighting that the vaccine, known as mRNA-1273, was previously available to this age group under emergency use authorization.

Moderna anticipates having an updated version of Spikevax available for U.S. patients by the 2025-26 respiratory virus season.

Moderna's CEO, Stéphane Bancel, welcomed the FDA's decision, emphasizing the continued threat of COVID-19 to children, especially those with underlying health conditions. He underscored the importance of vaccination in protecting children from severe illness and hospitalization.

This announcement comes amidst evolving guidance regarding COVID-19 vaccination. In May, the Centers for Disease Control and Prevention (CDC) announced that it would no longer recommend the vaccine for healthy children and pregnant women. This decision has prompted a legal challenge, with a coalition of doctors' groups and public health organizations filing a lawsuit in response.

BNN's Perspective:

The FDA's full approval of Moderna's vaccine for at-risk children is a positive step, providing a fully authorized option for protecting vulnerable populations. While the evolving guidance from the CDC reflects a changing understanding of the virus and its impact, the availability of a fully approved vaccine for those most susceptible to severe illness remains a crucial tool in public health. The ongoing legal challenges highlight the complexities and differing perspectives surrounding vaccine recommendations, underscoring the need for continued dialogue and evidence-based decision-making.

Keywords: Moderna, COVID-19 vaccine, Spikevax, FDA approval, children, mRNA-1273, Stéphane Bancel, CDC, vaccination, public health, emergency use authorization, at-risk, health conditions, lawsuit

Full Story