FDA May Limit Pfizer’s Pediatric COVID Vaccine Authorization, Raising Concerns for Fall Immunizations

The availability of covid-19/">COVID-19 vaccines for young children in the U.S. could shrink this fall as the Food and Drug Administration (FDA) considers ending the emergency use authorization (EUA) for Pfizer-BioNTech’s vaccine in kids ages 6 months to 4 years. Pfizer says it is in discussions with the FDA and has asked to keep the EUA for the 2025-26 season, stressing that the talks are not related to safety or effectiveness, which remain strong.

If the FDA does not renew Pfizer’s authorization, Moderna may need to fill the gap. The U.S. Centers for Disease Control and Prevention (CDC) is already working with Moderna to boost pediatric vaccine supplies, addressing issues like shipment timing and potential shortages. Moderna’s vaccine is approved for children as young as 6 months, but only for those with underlying health conditions that raise their COVID-19 risk. It is fully approved for everyone 65 and older.

By contrast, Pfizer’s pediatric authorization covers all children in the age group, regardless of health status. Without it, options for healthy young kids will be limited. Novavax’s vaccine is only approved for people 12 and older, and Pfizer’s fully approved shot starts at age 12 as well.

This potential shift comes amid broader changes in U.S. vaccine policy. Earlier this year, the CDC dropped its recommendation for COVID-19 shots in healthy children and pregnant women. HHS Secretary Robert F. Kennedy Jr. has welcomed such moves, citing limited evidence for repeated boosters in children.

If Pfizer loses its pediatric EUA, parents may face fewer choices for protecting young kids from COVID-19 this fall, especially those without health conditions that qualify them for Moderna’s shot.