FDA postpones advisory committee meeting on authorization of Pfizer-BioNTech COVID-19 vaccine for young children

Feb. 14, 2022

The U.S. Food and Drug Administration (FDA) has postponed its advisory committee meeting on an emergency use authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 vaccine in children 6 months through 4 years of age.

“As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. 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,” the agency said.

The meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee meeting was originally scheduled for February 15.

“We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation,” the agency said. 

The agency said it originally planned to base its decision on the EUA request on data based on two doses but would also like to review information about the companies’ evaluation of a third dose.

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