Pfizer Inc and BioNTech SE have submitted an application for US FDA authorization of a 10-µg booster dose of its pediatric COVID booster for children age 5 through 11 years old.
The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received the Pfizer pediatric COVID booster approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-µg two-dose primary series, which was authorized under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals.
The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years.
Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years 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 trial enrolled children with or without prior evidence of SARS-CoV-2 infection. In December 2021, Pfizer and BioNTech announced the companies would test a third 3-µg dose given at least two months after the second dose in children under age 5 and a third dose of the 10-µg formulation in children 5 to under 12 years of age. The companies expect to share data from the ongoing study in children 6 months to under 5 years of age later this quarter.
The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorization in the coming weeks.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both 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. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.