August 27, 2025

FDA’s Label Change to COVID-19 Vaccines Runs Counter to the Scientific Evidence

Today, the Food and Drug Administration (FDA) changed the labelling of COVID-19 vaccines in a manner that runs counter to the immense scientific evidence over multiple years we across the planet have amassed surrounding both the efficacy and safety of these vaccines. The FDA is limiting broad availability of these vital vaccines. particularly to the youngest children (< 2 years old) who face great risk of severe disease, hospitalization and death, even now.

The Pediatric Infectious Diseases Society (PIDS) stands firmly in support of the recommendations developed by the American Academy of Pediatrics (AAP) for COVID-19 vaccination: to immunize all children 6 months to 23 months of age, all children with high-risk conditions, and all children whose families want their children to receive vaccination. We strongly urge insurance companies to continue to cover these important preventive immunizations for all children and for health care policy officials to support their use.

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