16 % Most
Of the pediatric cohort in the U. S.
Diversity of any enrollment site
THE AMAZING PART
One of the most surprising aspects of the study itself was just how effective Pfizer’ s vaccine was in children.
“ We were giving one-third the dose as in older children and getting the same immune response,” Dr. Simões says.“ The study was actually not powered to show efficacy until 6 months out, but we were able to show efficacy by three months. That’ s the amazing part.”
As the Delta variant surged, just three children in the vaccine group contracted COVID-19. Infections in the placebo group increased steadily.
The data were clear: Pfizer’ s COVID-19 vaccine was safe and effective in children ages 5 to 11, and it received emergency use authorization from the FDA on Oct. 29, 2021. Less than two weeks later, the team published their preliminary results in the New England Journal of Medicine( 2).
The trial continues. The team followed participants through December, when they received a final blood draw to test for undetected infections and immune response. They’ ll continue to follow for another year and a half. Currently, they’ re gearing up for a modification of the trial beginning in February 2022, administering booster doses to participants at least 6 months from their initial dose to study their immune response.
Meanwhile, immediately following emergency use authorization, Children’ s Colorado partnered with the Colorado Department of Public Health and Environment to stand up vaccine clinics at Children’ s Colorado locations and through general pediatric practices in Children’ s Colorado’ s Pediatric Care Network. As of Dec. 7, 2021, those clinics had administered more than 22,000 doses, and that number continues to rise.
The study was so successful that the team was approached by Moderna to conduct a trial of similar proportions, although the team ultimately decided it was too much to absorb. That study eventually took place next door at the University of Colorado School of Medicine.
“ One lesson we took from this is that staff hired under our Research Institute are usually committed to projects. We don’ t have reserve staff that we can mobilize when something like this comes up,” says Dr. Simões.“ We did it. We got the nurses, the research coordinators, the pharmacists. Everyone was fabulous, and we found the space. But one thing that would help in the future is having a core of uncommitted staff to take on something like this. I hope we can build that.” •
ERIC SIMÕES, MD
Pediatric Infectious Diseases, Children’ s Hospital Colorado
Clinical professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine
Professor of Epidemiology, Center for Global Health
Department of Epidemiology, Colorado School of Public Health
ERIN SANDENE, BSN, RN, CCRC
Director, Research Operations and Administration, Children’ s Hospital Colorado
LALIT BAJAJ, MD, MPH / MSPH
Chief Quality and Outcomes Officer, Children’ s Hospital Colorado
Professor, Pediatrics-Emergency Medicine, University of Colorado School of Medicine
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