U.S. health officials postponed a meeting of advisers on Pfizer Inc.’s COVID-19 vaccine for children under age 5, after the drugmaker said it has new data to add to its application for clearance.
The Food and Drug Administration’s vaccine advisory committee had been planning to consider a two-dose regimen of the shot Tuesday. The delay is to allow the company and its partner BioNTech SE to gather and evaluate more information on the impact of a third dose, agency officials said in a statement.
“Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” Acting Commissioner Janet Woodcock and Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in the statement.
