HEALTH & POLICY | The U.S. Food and Drug Administration (FDA) is considering revoking its emergency use authorization of Pfizer’s COVID-19 vaccine for healthy children under the age of five, a move the drugmaker confirmed to CNBC on Tuesday.
This potential policy shift could significantly limit vaccination options for many of the nation’s youngest children, as COVID-19 shots from Moderna and Novavax are currently approved for more limited pediatric populations. While COVID-19 typically results in mild illness for most children, infants under one and those with certain underlying health conditions remain at a higher risk for severe outcomes, including hospitalization.
Pfizer stated that the FDA has indicated it may not renew the vaccine’s longstanding authorization for children ages 6 months to 4 years. In response, Pfizer has requested the authorization remain in place for the upcoming fall and winter season and is “currently in discussions with the agency on potential paths forward.”
Crucially, Pfizer asserted that the FDA’s “deliberations” are not related to the vaccine’s safety or efficacy, which the company says “continues to demonstrate a favorable profile.”
This development is part of a series of recent changes to U.S. immunization policy since Robert F. Kennedy Jr., a prominent vaccine skeptic, became the Secretary of Health and Human Services (HHS). In May 2021, Kennedy filed a petition demanding that the FDA revoke authorization of mRNA vaccines. More recently, in May of this year, Kennedy announced the Centers for Disease Control and Prevention (CDC) had removed its universal recommendation of COVID-19 vaccines for healthy children and pregnant women.
Subsequent CDC guidance clarified that the shots “may” be given to these children if a doctor deems it necessary. The recommendation for pregnant adults was changed to “No Guidance/Not Applicable.”
The potential removal of the Pfizer vaccine would leave a gap in coverage. Moderna’s mRNA vaccine only has full FDA approval for children with one or more health conditions that put them at high risk, and Novavax’s protein-based shot has never been authorized for children under 12.
According to a report from The Guardian, which first broke the story, Moderna is now working with the CDC to boost its supply of COVID-19 shots for children in anticipation of the potential change.
