INFECTIOUS DISEASE
Advances and Answers in Pediatric Health
Shaping the Protocol
Could a massive study of a COVID-19 vaccine in children also reflect the populations most at risk ?
Children under 18 years old generally have milder disease than adults , but they carry COVID just as effectively , making up 20.8 % of COVID cases and 22.2 % of the U . S . population at large . In mid-December 2021 , children were contracting COVID at a rate of nearly 200,000 new cases per week ( 1 ). They ’ re a crucial segment of the population to vaccinate .
In 2021 , Children ’ s Hospital Colorado played a central role in the effort to clinically validate Pfizer ’ s COVID-19 vaccine for children , enrolling 252 participants altogether . It wasn ’ t just the largest study group , at 11 % of the study population worldwide . It was also , very intentionally , the most diverse .
Clinical trials are rarely a big draw for the general public .
“ Typically at a pediatric academic institution we ’ re engaged in trials for rare disease , and it ’ s a specific medication or device ,” says Erin Sandene , director of research operations at Children ’ s Colorado . “ You don ’ t often have people champing at the bit to be part of a research study .”
For its phase 3 trial of the Pfizer vaccine — the first to receive emergency authorization for use in children ages 5 to 11 from the Food and Drug Administration — Children ’ s Colorado received more than 5,000 initial applicants .
“ That ’ s huge ,” Sandene says .
The slew of public interest presented an opportunity : For Pfizer , it was a chance to capture a large amount of pediatric data and lead the pack in making its vaccine available to the public . For Children ’ s Colorado , it was a chance to be part of something bigger , but also to advance a strategic priority that had been gathering steam all year : the effort to bring better representation to clinical research .
COVERING ALL THE BASES
Pediatric infectious disease specialist Eric Simões , MD , has been leading clinical trials for decades . As a key player in the World Health Organization ’ s effort to help manage common pediatric conditions in low- and middle-income countries , he specializes in the prevention of long- and short-term effects of respiratory syncytial virus , or RSV . In fact , it was his role as primary investigator in a Pfizer RSV prevention trial that led to Children ’ s Colorado ’ s designation as a supersite for its COVID vaccine trial .
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