FDA Grants Full Approval to Moderna COVID Shot for At-Risk Kids
The U.S. Food and Drug Administration (FDA) has granted full approval to the Moderna COVID vaccine approved for high-risk children aged 6 months to 11 years, marking a significant policy shift. This decision makes Moderna’s pediatric shot the first COVID-19 vaccine for children no longer administered under emergency use authorization.
However, the newly approved vaccine is now only available to children with underlying health conditions that put them at elevated risk for severe COVID-19 outcomes.
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The FDA’s decision follows a major announcement earlier this year from Health and Human Services Secretary Robert F. Kennedy Jr., who declared that the federal government would stop recommending COVID-19 vaccination for healthy children and pregnant women—a major departure from prior health guidance.
“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions,” said Stéphane Bancel, CEO of Moderna. “Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization.”
While both Moderna and Pfizer previously offered vaccines to all children regardless of health status, the FDA’s updated authorization now restricts use of the Moderna COVID vaccine to high-risk children only. The move is in line with Secretary Kennedy’s position that healthy children face minimal danger from COVID-19, and that the risks of vaccination may outweigh the benefits for those without existing health concerns.
Infants under 6 months of age remain ineligible for any COVID-19 vaccine.
In the wake of the FDA’s announcement, the Centers for Disease Control and Prevention (CDC) issued updated guidance urging parents to use “shared clinical decision-making” in consultation with healthcare providers—an approach that replaces blanket recommendations with case-by-case discussions.
Still, the policy change has drawn criticism. On Monday, prominent medical organizations—including the American Academy of Pediatrics—filed a lawsuit against Secretary Kennedy, arguing that restricting vaccine access undercuts parental choice and endangers public health.
In defense of the administration’s decision, HHS spokesman Andrew Nixon said:
“Healthy children with COVID-19 have consistently shown strong resilience and face an extremely low risk of serious illness or harm. The risks of the COVID-19 vaccine may outweigh the potential benefits.”
Moderna has stated that it will make its updated COVID vaccine available for eligible high-risk children ahead of the 2025–2026 respiratory virus season.
DailyClout.IO will continue to cover this story. Source article posted here.
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