Children’s Hospital Colorado Participates in Pfizer Pediatric COVID-19 Vaccine Trial

Children’s Hospital Colorado (Children’s Colorado) is participating in the Pfizer/ BioNTech COVID-19 investigational vaccine study for children ages 5 to 11. The study is intended in part to determine if the vaccine can produce an immune response against COVID-19, and if it is safe, in children.

Pediatric infectious disease expert to lead study at Children's Colorado

The study at Children’s Colorado is being led by Eric Simões, MD, pediatric infectious disease expert at Children’s Colorado and professor of pediatrics at the University of Colorado School of Medicine on the Anschutz Medical Campus. His past global research has addressed respiratory illnesses in mothers and children around the world.

“Children need a vaccine,” says Simões. “The vaccine trials get us one step closer to protecting our children and our communities from COVID-19.”

COVID-19 study participants will be followed for two years

Children’s Colorado recruited and enrolled healthy children, ages five to less than or equal to 11 years of age. Each child is randomly assigned to receive either the study vaccine or a placebo in a 2:1 vaccine to placebo ratio. They will receive two injections approximately three weeks apart. Then, over the course of two years, families will have scheduled follow-up study visits and be required to track any changes in their child’s health in an electronic diary.

Neither the family nor the doctor will know whether the child received the study vaccine or placebo until their follow-up visit six months after the second injection. Any child in the study that received the placebo, will then be offered the COVID-19 study vaccine.

Lottery selection ensures the study population reflects the surrounding communities

Children were selected through a lottery system to ensure that the population demographic in the study reflects the population of the surrounding cities.

Currently, there are no approved COVID-19 vaccines available for children aged 11 and under. Before these types of vaccines can be approved by the United States Food and Drug Administration, COVID-19 vaccines need to be studied in a clinical trial that involves children.

Developing potential vaccines to prevent this disease in children is an important part of the fight against COVID-19.