Pfizer-BioNTech Will Study Their COVID-19 Vaccine in Pediatric Populations

Pfizer-BioNTech announced yesterday it is beginning an international study to evaluate the safety, tolerability, and immunogenicity of their COVID-19 vaccine in healthy children ages 6 months to 11 years old.

The companies stated the phase 1/2/3 dose-escalation study will be a 2-dose schedule (approximately 21 days apart) in three age groups: ages 5 to 11 years; 2 to 5 years; and 6 months to 2 years.

Children younger than 6 months of age may subsequently be evaluated, once an acceptable safety profile has been established. They are looking to enroll approximately 4644 children and the trials will take place in the US and Europe.

The companies expect study results in the second half of this year and potentially applying for authorization in the early part of 2022.

This news comes after Moderna announced last week it was going to be studying their vaccine in the pediatric populations.

This is part of an overall strategy to get greater utilization of the vaccines into the collective population with the hope of making a return to school in the future safer and protect children, teachers, administrators, and family members at home. If there is the possibility of herd immunity, immunization in children will be necessary.

"Children under the age of 15 account for 26% of the global population," Pfizer wrote on its website. "We believe successfully vaccinating children will contribute to protection against COVID-19 if the vaccine proves to be effective in that population."

Currently, the Pfizer-BioNTech vaccine is authorized in the US for people 16 years and older. More US states are opening up eligibility for COVID-19 vaccines in this younger population as the race to ramp-up vaccinations continues.

President Joe Biden announced yesterday he updated his vaccination goal from 100 million vaccines administered to 200 million doses given by his first 100 days in office.