Pfizer Launches COVID-19 Vaccine Study With Children
Pfizer's website confirmed on March 25, 2021, they have dosed the first healthy children in a global Phase 1/2/3 continuous study to evaluate further the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in 4,644 children between the ages of 11 years to 6 months.
Vaccine effectiveness in the study will be inferred through immunobridging to the 16-25-year-old population from the pivotal Phase 3 trial.
This new study will evaluate a two-dose schedule (approximately 21 days apart) in three age groups:
- Children ages 5 to 11 years,
- 2 to 5 years,
- And 6 months to 2 years.
If safety and immunogenicity are confirmed and pending agreement with and endorsement from regulators, Pfizer stated it 'hopes to receive authorization for vaccination of these younger kids by early 2022. Children younger than 6 months of age may subsequently be evaluated once an acceptable safety profile has been established.'
'We believe successfully vaccinating children will contribute to protection against COVID-19 if the vaccine proves to be effective in that population.'
At the end of 2020, the US Centers for Disease Control and Prevention reported there was a total of 888 hospitalizations related to COVID-19 by children less than five years of age.