Children’s Mercy Begins Pfizer COVID-19 Vaccine Trial in Children
Children’s Mercy announced today it will be leading the regional efforts of a nationwide pediatric COVID-19 vaccine clinical trial by participating in the Pfizer-BioNTech global Phase 1/2/3 continuous study. This study will further evaluate the safety, tolerability, and immunogenicity of the COVID-19 vaccine (BNT162b2) in healthy children ages 6 months to 11 years.
Barbara Pahud, MD, MPH, Director of Research, Infectious Diseases, is leading the trial at Children’s Mercy.
“This is a much-needed study that will help us continue gathering evidence on the efficacy of the already developed vaccine on our younger populations, including children and infants,” said Dr. Pahud. “While the virus has affected more adults, children have also died and been hospitalized, and our goal is that COVID-19 will become another vaccine-preventable disease which will save lives.”
The first stage (Phase 1) of the study is finding the correct dose of the vaccine. After the correct dose is found, in Phase 2/3 participants will be randomized in a 2:1 ratio to receive active vaccine or placebo. In both stages, participants will have their blood drawn prior to receiving both Dose 1 and Dose 2 (approximately a month apart) and again, 7 days after receiving Dose 2 to assess immunogenicity to determine with the safety data the final BNT162b2 dose level for each age group. Participants will also have a nose swab collected prior to receiving both Dose 1 and 2 to test for COVID-19 antigen testing.
For those participating in Phase 2/3, 6 months after receiving the second dose, all participants will be unblinded and those who originally received placebo will be offered the opportunity to receive BNT162b2.
Children as young as 7 will need to give their own permission to participate in the study at Children’s Mercy.
“Clinical trials and research are an important step in discovering new treatments for diseases and necessary if we want to find a vaccine to achieve herd immunity from COVID-19, but it’s important for families to understand that participating in a clinical trial is 100% voluntary,” said Dr. Pahud. “This trial requires a number of shots, blood draws and nasal swabs, and our goal is to ensure children feel comfortable and safe while samples are collected. At any point, if the child no longer wants to be a part of the study, that child can stop.”
If safety and immunogenicity is confirmed, and pending authorization or approval from regulators, Pfizer hopes the vaccine could be available to these younger children between the ages of 6 months and 11 years by early 2022.
To be considered for a clinical trial at Children’s Mercy, parents or guardians can complete a voluntary registry form.