The companies made the request after their recent submission of data to support the emergency use authorization (EUA) in this patient population.
Pfizer-BioNTech have asked the Food and Drug Administration (FDA) to grant its COVID-19 vaccine, BNT162b2 (Comirnaty), an EUA in the 5 to 11 year old population, according to a report in the NY Times.
According to the article, the FDA has tentatively scheduled a meeting on October 26 to consider it, and a ruling is expected between Halloween and Thanksgiving.
The companies submitted their data to FDA at the end of September to support this patient population. Trial investigators conducted studies utilizing 2 doses of 10mcg 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.
Overall, the Phase 1/2/3 trial initially enrolled up to 4500 children ages 6 months to <12 years of age in the US, Finland, Poland, and Spain from more than 90 clinical trial sites. It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a 2-dose schedule (approximately 21 days apart) in three age groups: ages 5 to <12 years; ages 2 to <5 years; and ages 6 months to <2 years. Based on the Phase 1 dose-escalation portion of the trial, children 5 to <12 years of age 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 COVID-19.
At the time of the announcement at the end of September, the companies said they were anticipating “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.