Pfizer and BioNTech reported that data from their COVID-19 vaccine Phase 2/3 study in children aged 5 to 12 years old has been submitted to the US Food and Drug Administration (FDA). A formal submission to request Emergency Use Authorization is expected to follow in the coming weeks.
On September 20, 2021, the companies revealed favorable topline outcomes from the pivotal study. The vaccine showed a satisfactory safety profile and generated substantial neutralizing antibody responses utilizing a two-dose regimen of 10 μg doses in the study, which comprised 2,268 participants aged 5 to 12. These findings, which are the first from a pivotal trial of any COVID-19 inoculation in this age range, appear identical to those from a prior study, although individuals aged 16 to 25 were vaccinated with 30 μg doses in a Pfizer-BioNTech trial.
In children aged 5 to 12, the 10μg dosage was precisely chosen as the optimal dose for safety, tolerability, and immunogenicity. The FDA has been provided with this data for their preliminary evaluation. In the coming weeks, the companies are anticipated to submit a formal request for Emergency Use Authorization (EUA) for their COVID-19 vaccine in children aged 5 to 12. There will also be submissions to the European Medicines Agency (EMA) and other regulatory bodies.
Topline immunogenicity and safety results for the trial’s other two age groups — children aged 2 to 5 years and children aged 6 months to 2 years – are due in the fourth quarter of this year.
Pfizer and BioNTech intend to submit results from the whole Phase 3 study for publication in a scientific journal.
About the Phase 1/2/3 Trial in Children
More than 90 clinical trial sites in the United States, Finland, Poland, and Spain initially enrolled up to 4,500 children with or without prior evidence of SARS-CoV-2 infection aged 6 months to 12 years old in the Phase 1/2/3 trial. It was dedicated to assessing the vaccine’s safety, tolerability, and immunogenicity in three age cohorts: ages 5 to 12 years, ages 2 to 5 years, and ages 6 months to 2 years, on a two-dose schedule (about 21 days apart). Children aged 5 to 12 received a two-dose regimen of 10μg each in the Phase 2/3 study, based on the Phase 1 dose-escalation part of the trial, while children under the age of 5 received a lower 3 μg dosage for each inoculation.
Both BioNTech and Pfizer Put efforts to jointly develop the Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s patented mRNA technology. BioNTech is the holder of marketing authorizations in the U.S, the European Union, the U K, and Canada, as well as emergency use authorizations or equivalents jointly with Pfizer in the United States and other countries.
Planned submissions will be made to pursue regulatory approvals in countries where emergency use authorizations or equivalents were awarded originally. The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. Although they may be manufactured in different plants, the products offer the same safety and effectiveness.