Pfizer-BioNTech Submits Pediatric COVID-19 Vaccine Data to FDA

The companies will be seeking emergency authorization for a lighter-dose mRNA vaccine for children aged 5 to <12 years old.

Pfizer-BioNTech has submitted data to the US Food and Drug Administration (FDA) supporting the companies’ bid for authorized use of their COVID-19 vaccine in children aged 5 to <12 years old.

The developers of 2-dose mRNA vaccine BNT162b2 announced Tuesday morning that phase 2/3 trial data, featuring 2200-plus pediatric participants and data supporting the vaccine’s benefit and safety in children, has been submitted to the FDA as part of their pending Emergency Use Authorization (EUA) submission for this patient population. The formal submission is planned for coming weeks.

Investigators observed a pair of 10mcg doses of BNT162b2 in 2268 pediatric trial participants for its safety, tolerability, and immunogenicity. According to Pfizer, their phase 2/3 findings are comparable to those observed in an assessment of BNT162b2 in adults and adolescents aged 16-25 years old.

The companies are also anticipating to provide “topline” immunogenicity and safety readouts from 2 different age cohorts of the trial in the fourth quarter of 2021: children aged 2 to <5 years old, plus children 6 months to <2 years old. Phase 3 data from Pfizer-BioNTech’s international pediatric trial program will be submitted for publication in a peer-reviewed publication in the near future.