FDA may pull authorization for Pfizer COVID shot for kids under 5

The Food and Drug Administration (FDA) is considering revoking the authorization of Pfizer’s COVID-19 vaccine for healthy children under 5 years old, the company confirmed Wednesday. 

The move would add another barrier for parents who want to vaccinate healthy children, as shots from Moderna and Novavax were approved for more limited populations.  

In May, Health and Human Services Secretary Robert F. Kennedy Jr. said the Centers for Disease Control and Prevention (CDC) would no longer recommend COVID-19 vaccines for healthy children or pregnant women.  

The CDC then updated its immunization schedule to reflect that children with no underlying health condition “may receive” COVID-19 vaccines after consulting with a health care provider — what’s known as “shared decisionmaking.” 

If the FDA pulls its emergency use authorization (EUA), Pfizer’s vaccine would no longer be available to any children younger than 5. Right now, Moderna and Novavax shots could be administered “off label” to healthy children. 

“We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season,” a Pfizer spokesperson told The Hill.  

“It is important to note that these deliberations are not related to the safety and efficacy of the vaccine which continues to demonstrate a favorable profile,” the company added.  

The Guardian first reported on the FDA’s potential move. 

In a statement to The Hill, the Health and Human Services (HHS) Department said it wouldn’t comment on potential changes.  

“The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023. We do not comment on potential, future regulatory changes. Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation,” HHS spokesperson Andrew Nixon said. 

Pfizer has had full FDA approval for its COVID-19 vaccine for people 12 years old and older since 2022.