September 29, 2021 – According to a report from The Washington Post, Pfizer and BioNTech submitted initial data to the FDA from a vaccine trial on young children. This trial consisted of 2,268 participants between the ages of 5 to 11 years old, which yielded favorable results to the efficacy and safety of the vaccine.
In a media release, the companies outline the plan to formally submit an Emergency Use Authorization of the vaccine, saying the results “were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age.”
This study comes on the heels of the Delta variant surge over the last couple of months, which has seen an increase in infection rates in young children. The Pfizer-BioNTech vaccine has already received FDA approval for people over 16 in the United States, as well EUA for children from 12 to 15 years old.
Pfizer’s continued testing of their vaccine mirrors the desperation that the country is facing to emerge from the coronavirus pandemic. The release goes on to say that “topline immunogenicity and safety readouts for the other two age cohorts from the trail – children 2 to <5 years of age and children 6 months to <2 years of age – are expected as soon as the fourth quarter.”
Could we see the authorized vaccination of children 11 years old and younger by early 2022? It’s still too early to be sure, but Pfizer’s favorable results indicate that the vaccine could potentially be available to the age demographic that has been more affected by the Delta variant.