The FDA has postponed a Feb 15 meeting to discuss authorization of the Pfizer vaccine for children age 6-months through 4-years-old.
The FDA has postponed a Feb 15 meeting of its Vaccines and Related Biological Products Advisory Committee that was intended to discuss emergency use authorization of a two-dose regimen of the Pfizer-BioNTech vaccine for children age 6-months through 4-years-old. According to the FDA, the delay will give it time to consider additional data from Pfizer on a three-dose regimen of the vaccine for this age group. .
“We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” the FDA said in a statement.
Since the early days of the pandemic, we have always followed the science in this ever-changing situation. 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. 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. Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered.
The agency will ensure the data support effectiveness and safety before authorizing a COVID-19 vaccine for use in our youngest children. In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caregivers to get vaccinated or receive a booster dose when eligible.