DURHAM, N.C. -- Twin 9-year-old girls at Duke Health became the first in the United States to participate in a Pfizer and BioNTech Phase 1 study to evaluate safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in preventing COVID-19 among healthy children below the age of 12.
The participants -- Alejandra and Marisol Gerardo -- received their first vaccinations on Wednesday, March 24.
This first phase of the study will evaluate three different dosage levels, with 16 healthy children assigned to each of the three dosage levels. Each participant will receive two doses, 21 days apart.
Data on the safety and immune responses from these first 48 children will help guide the selection of the dose level of vaccine to be used in the second phase of the study.
The Phase 2/3 part of the trial will evaluate the safety, tolerability, and immunogenicity of the selected dose level in each age group from Phase 1 and will enroll up to 4,500 children below the age of 12.
Duke’s participation in this first phase of the study will enroll a total of 12 children.
“The importance of safely vaccinating children against COVID-19 is twofold,” said the study’s principal investigator at Duke is Emmanuel “Chip” Walter, MD, professor of Pediatrics and chief medical officer of the Duke Human Vaccine Institute.
“First, children can develop serious infection and the consequences of infection include death,” Walter said. “There have been more deaths in children during the past year than during a typical flu season. Second, being able to vaccinate children is an important component of developing herd immunity, or population-level protection, as children makeup a significant proportion of our population."