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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