Pfizer-BioNTech has filed data with the U.S. Food and Drug Administration (FDA) in support of the companies’ bid for authorized use of their COVID-19 vaccine in children 5 to <12 years old.
The developers of the 2-dose mRNA vaccine BNT162b2 announced Tuesday morning that Phase 2/3 trial data, with more than 2,200 pediatric participants and data supporting the vaccine’s benefit and safety in children, has been submitted to the FDA as part of of their pending use in emergencies. Submission of authorization (EUA) for this patient population. The formal submission is scheduled for the coming weeks.
Researchers observed a few doses of 10 mcg BNT162b2 in 2268 pediatric subjects for its safety, tolerability and immunogenicity. According to Pfizer, their phase 2/3 findings are similar to those seen in an assessment of BNT162b2 in adults and adolescents aged 16-25 years.
The companies also expect to deliver “topline” immunogenicity and safety measurements from 2 different age cohorts of the trial in the fourth quarter of 2021: children 2 to <5 years old, plus children 6 months to <2 years old. Phase 3 data from Pfizer-BioNTech's International Pediatric Pilot Program will be submitted for publication in a peer-reviewed publication in the near future.