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
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
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