Pfizer, BioNTech Receive EUA for COVID Vax in Children 5 to 11

Pfizer Inc. and BioNTech SE received authorization from the U.S. FDA for emergency use of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age. The vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for this age group.
 
The FDA based its decision on data from a Phase 2/3 randomized, controlled trial that included ~4,500 children 5 through 11 years of age (2,268 from the original group and 2,379 from the supplemental safety group). In the trial, the vaccine demonstrated a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.
 
The companies will begin shipping 10-µg pediatric doses immediately, as directed by the U.S. government.
 
As a next step, the U.S. CDC Advisory Committee on Immunization Practices (ACIP) will meet next week to discuss a potential recommendation for the use and rollout of the vaccine to children 5 through 11 years of age. Pediatric vaccinations are anticipated to start, subject to, and after, CDC endorses the ACIP recommendation.
 
Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the EMA. Initial data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children – those 2 to <5 years of age and those 6 months to <2 years of age – are expected as soon as 4Q21 or early 1Q22.  
 
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.