FDA Postpones VRBPAC Meeting to Review Pfizer COVID-19 Vaccine EUA Request for Young Children

The U.S. Food and Drug Administration (FDA) announced today it is postponing the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting originally scheduled for Monday, February 15 to review the emergency use authorization (EUA) request from Pfizer and BioNTech for the COVID-19 vaccine in children six months through four years of age.

The FDA notes that it has been notified by Pfizer that new data have recently emerged from its ongoing clinical trial among young children. Based on the FDA’s preliminary assessment, and to allow more time to evaluate additional data, the FDA states, “we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”

Additional information from the FDA is available here.