The Food and Drug Administration’s (FDA’s) review of Pfizer’s COVID-19 vaccine for children aged 6 months through 4 years has been delayed to allow the agency to consider a potential third dose for that age group.
FDA’s Vaccines and Related Biological Products Advisory Committee was set to consider the vaccine on Feb. 15, but the agency announced the postponement on Feb. 11, saying Pfizer had notified it of additional findings from Pfizer’s ongoing clinical trial.
“Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study,” FDA said. “The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group. Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness.”
FDA said it would “provide an update on timing” for the committee meeting “once we receive additional data on a third dose in this age group … and have an opportunity to complete an updated evaluation.”
Last Updated On
April 05, 2022
Originally Published On
February 14, 2022