Pfizer-BioNTech Seek Authorization to Vaccinate Children

New York-based Pfizer Inc. and BioNTech SE today announced they had submitted data to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.

The Companies previously announced positive topline results from the pivotal trial on September 20, 2021. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.

These data have been shared with the FDA for the Agency’s initial review.

A formal submission to request Emergency Use Authorization (EUA) of the companies’ COVID-19 vaccine in children 5 to <12 years of age is expected to follow in the coming weeks.

In addition, submissions to the European Medicines Agency and other regulatory authorities are also planned.

Furthermore, topline immunogenicity and safety readouts for the other two age cohorts from the trial – children 2 to <5 years of age and six months to <2 years of age – are expected as soon as the fourth quarter of 2021.

The Phase 1/2/3 trial initially enrolled up to 4,500 children ages six months to <12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites.

It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to <12 years; ages 2 to <5 years; and ages six months to <2 years.

Based on the Phase 1 dose-escalation portion of the trial, children 5 to <12 years of age received a two-dose schedule of 10 μg each while children under age 5 received a lower 3 μg dose for each injection in the Phase 2/3 study.

The Pfizer-BioNTech Comirnaty COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

The Comirnaty vaccine is administered as a 2-dose series, three weeks apart. In addition, a third dose may be administered at least four weeks after the second dose to individuals determined to have certain kinds of immunocompromise.