The U.S. Food and Drug Administration (FDA) announced Friday that it has postponed an advisory panel meeting on the use of the Pfizer-BioNTech COVID-19 vaccine in children six months through four years of age, saying it needs more data.
The meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee was originally scheduled for Feb. 15.
The agency said it had reviewed new trial information that arrived after Pfizer and BioNTech’s request for emergency authorization and decided it needed more data from an ongoing trial of a third vaccine dose in younger children in order to move forward with emergency use authorization.
“We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” said the agency in a statement.
Pfizer and BioNTech said Friday that they expected to have data on three doses available in early April.