This story is an update to an original story written by Christine Mueri on the My Children’s site.
Physician-scientists in Omaha will be on the leading edge of research to ensure a safe, effective pediatric COVID-19 vaccine as CHRI coordinates a study site for Pfizer’s COVID-19 vaccine trial in children. Kari Simonsen, MD, MBA, chair of the UNMC Department of Pediatrics and pediatrician-in-chief at Children’s Hospital & Medical Center, will serve as the site principal investigator.
The trial will evaluate the vaccine’s safety and efficacy in healthy children. CHRI will partner closely with Children’s Physicians primary care offices to recruit study participants starting in late spring or early summer; however, children not cared for at these locations may also be enrolled. This global study will involve around 6,000 pediatric participants. The Omaha site plans to enroll around 50 children, likely starting in late May/early June. Vaccine administration will take place at Children’s Infectious Disease clinic, led by Children’s Pediatric Infectious Disease specialists. Pediatric participants can be recruited from throughout the community and region and must be able to attend scheduled study visits in Omaha. Several medical exclusions for children in the study apply, including any prior treatment with medication intended to prevent COVID-19 or any history of MIS-C.
Phase 1 is an open-label, dose-finding study to evaluate safety, tolerability, and immunogenicity, with no placebo arm. Participants will receive a vaccine dose in one of three potential doses for their age cohort (staged low-med-high), and blood sampling prior to dose one and dose two (day 21) and 7 days after dose two to assess immunogenicity and inform dosing in Phase 2/3.
Phase 2/3 will be a placebo-controlled, observer-blinded safety, tolerability, and immunogenicity study of a SARS-CoV-2 RNA vaccine candidate against COVID-19 in healthy children. Phase 2 will evaluate up to three dose levels of BNT162b2 in up to three age groups (5-11 years, 2-4 years, 6 -23 months of age). Phase 2/3 participants will be randomized 2:1 (vaccine: placebo). They will have vaccine visits on day 1 and 21. Blood sampling will occur prior to dose one, and at 1 month and 6 months post-second dose. A subset will have another blood sampling at 12-months or at 24-months post-vaccination. At the 6-month post-dose visit, unblinding will occur and vaccination will begin for those initially assigned to the placebo arm. Patients will be evaluated throughout the study for any symptoms consistent with COVID-19, with 12-month and 24-month phone call follow-ups.
“COVID-19 vaccine studies for children build on the knowledge gained from the completed adult studies. This important trial provides necessary safety and effectiveness information to expand implementation of COVID-19 vaccines. We are proud to contribute to these global efforts,” says Dr. Simonsen.
“CHRI is excited to support this vaccine study conducted by our highly skilled investigators at our sponsoring institutions, Children’s and UNMC. Bringing world-class research to the children of Omaha and Nebraska is core to our mission, and we are proud to be a part of ensuring that children have safe and effective access to a COVID-19 vaccine in a timely manner,” says Ann Anderson Berry, MD, PhD, executive director of CHRI.
To reach the study team for the Pfizer Pediatric COVID-19 vaccine, email PedsResearch@unmc.edu with the subject line “Pfizer COVID-19 vaccine study.” Please specify whether you have an interest/question regarding pregnancy study or pediatric study. The study team is creating a spreadsheet for pre-screening potentially interested participants.