Pfizer, BioNTech Submit Initial Data to FDA Seeking EUA for COVID-19 Vaccine in Children Ages 5-11

The FDA has received data from Pfizer and BioNTech from a phase 2/3 trial of their COVID-19 vaccine in children between 5 and 12 years of age, according to a company press release.

Positive results were seen in the pivotal trial from September 20, 2021, which included 2268 participants between 5 and 12 years of age. The vaccine demonstrated a promising safety profile and showed vigorous antibody responses using a 2-dose regimen of 10 μg doses, according to the release.

The results were compared to those in the previous Pfizer-BioNTech study in people between 16 and 25 years of age who were immunized with 30 μg doses. Further, the 10 μg doses were carefully picked as the preferred dose for safety, tolerability, and immunogenicity in children between 5 and 12 years of age.

A formal submission to request Emergency Use Authorization of the COVID-19 vaccine in children is expected in the coming weeks, including submissions to the European Medicines Agency and other regulatory authorities outside the United States. Immunogenicity and safety readouts for the other 2 age cohorts from the trial (children between 2 and 5 years of age and between 6 months and 2 years of age) are expected to come by the end of the year, according to the press release.

REFERENCE

Pfizer and biontech submit initial data to U.S. FDA from pivotal trial of covid-19 vaccine in children 5 to <12 years of age. Pfizer. September 28, 2021. Accessed September 28, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal