Moderna Vaccine for Children Gets Full FDA Approval Ahead of Fall Virus Season

NORTH CAROLINA — The U.S. Food and Drug Administration (FDA) has granted full approval for Moderna’s COVID-19 vaccine, Spikevax, in children aged six months through 11 years who are at increased risk of the disease, according to a statement released by the company on July 10.

The vaccine, previously authorized only for emergency use, is now fully approved for pediatric use in the U.S., marking a major step ahead of the 2025–26 respiratory virus season. Moderna said it will begin distributing the updated formulation this fall.

“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions,” said Moderna CEO Stéphane Bancel, adding that vaccination is a critical tool for preventing severe illness and hospitalization in young patients.

Part of a Shifting National Vaccine Strategy

The FDA’s decision comes at a time when national guidance on COVID-19 vaccination is undergoing rapid change. In May, Health and Human Services Secretary Robert F. Kennedy announced that the Centers for Disease Control and Prevention (CDC) would no longer recommend COVID-19 vaccination for “healthy” children and pregnant women.

That announcement sparked immediate pushback. A coalition of doctors and public health organizations — including the American Academy of Pediatrics — filed a lawsuit against the CDC’s updated recommendations, alleging that the rollback jeopardizes vulnerable populations.

According to NewsNation, this legal challenge aims to reinstate prior vaccine recommendations and block further erosion of federal public health authority on immunizations.

Moderna’s Updated Vaccine Will Target Current Variants

The fully approved Spikevax formulation Moderna plans to release this fall is designed to offer broader protection against circulating COVID-19 variants. Moderna emphasized that it is “working closely with regulators to ensure availability” before the winter season.

The approval applies specifically to children at increased risk, such as those with respiratory conditions, compromised immune systems, or chronic illness. For now, the vaccine is not recommended for children outside those categories, based on current federal guidance.

What Parents in North Carolina Should Know

• Pediatric patients with conditions like asthma, diabetes, or heart disease may be eligible for vaccination under the new FDA approval.
• Parents are urged to consult their child’s healthcare provider to determine eligibility before the fall.
• The vaccine is not yet required for public school attendance, but this may vary by local health authority.

Are you a North or South Carolina parent navigating the latest vaccine changes? Let us know how these shifting guidelines affect your family in the comments at SaludaStandard-Sentinel.com.