Children's Hospital Colorado

Children’s Hospital Colorado Celebrates Authorization of Pfizer’s COVID-19 Vaccine for Kids 5+

Children's Hospital Colorado | November 12, 2021

This page was updated January 2022 to reflect changes to Children's Colorado's vaccine clinics. 

As of November 2, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have announced final emergency use authorization and recommendation of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11. The vaccine was previously authorized for emergency use in adolescents ages 12 and older and has full FDA approval for use in individuals ages 16 and older.

“Children’s Colorado is excited for this next chapter in the fight against COVID-19. The more people who can get vaccinated – including children – the sooner we can get back to some normalcy,” said David Brumbaugh, MD, Chief Medical Officer. “By vaccinating the 5 to 11 age group we are one step closer to being able to protect our whole community. We encourage everyone to learn about the COVID-19 vaccines and get vaccinated as soon as they are able.”

With the eagerly anticipated recommendation of the Pfizer vaccine for ages 5 and older, approximately 450,000 Colorado children – about 12% of the state population – are now eligible to receive a COVID-19 vaccine, protecting them from the virus and its potential complications. The federal health authorities’ recommendations come after data from a historic worldwide clinical trial show that the vaccine is safe and produces a substantial immune response in this age group.

Children’s Colorado a supersite in Pfizer’s COVID-19 vaccine trial for ages 5 to 11

Children’s Colorado was the largest clinical trial site in Pfizer’s pediatric COVID-19 vaccine trial, which began over the summer. The hospital is one of 80 sites across the U.S. and is a trial “supersite,” representing the largest number of participants in this age group worldwide. Parents of about 5,000 Colorado children signed up to be considered for the study, which ultimately enrolled 252 participants. Our team meticulously organized and ran the trial, which had a 2:1 vaccine to placebo ratio.

The clinical trial was double-blind, meaning neither participants nor study organizers knew which participants received the vaccine and which received placebo. When the FDA authorized the Pfizer vaccine for children 5 and older, trial participants were “unblinded,” and participants who received the placebo were invited to receive the vaccine at Children’s Colorado.

Study participants demographically diverse

Children’s Colorado was proud to recruit a diverse group of pediatric trial participants that is generally representative of Aurora and the entire Colorado community. Approximately 60% of participants identified as white, with the remaining 40% of participants identifying as multiracial (15%), Black (7.9%), Asian (7.1%), other or prefer not to answer. About 35.2% of participants identified as Hispanic or Latino, while 60.1% identified as non-Hispanic or Latino and 4.7% did not answer.

“It was important to us to ensure that the diversity in the trial reflected the diversity of the population surrounding the hospital,” said Eric Simões, MD, the trial site’s principal investigator and pediatric infectious disease expert at Children’s Colorado. “We’re grateful to the families who came forward to represent their communities, ensuring we assessed safety and efficacy among the groups most impacted by COVID-19.”

Dr. Simões' work, along with colleagues at other trial sites, was highlighted in the New England Journal of Medicine in early November.

Safe and effective: vaccine benefits outweigh risks for kids 5+

The FDA and CDC analysis of Pfizer’s vaccine trials in children ages 5 to 11 found that the vaccine mounted a substantial immune response against COVID-19 in participants. The emergency use authorization and CDC recommendation show that the vaccine is safe and efficacious in children ages 5 and older and that the benefits of the vaccine’s protection outweigh the risks. Getting the vaccine helps keep kids safe and protected from the risks of COVID-19.

Impacts of COVID-19 on children

“I have treated countless scared kids and parents who have come into the emergency department struggling to breathe – which is frightening for kids and parents alike,” said Lalit Bajaj, MD, MPH, Chief Quality and Outcomes Officer at Children’s Colorado and one of the executive sponsors of the clinical trial at the hospital. “It’s incorrect to say COVID is not serious in children. Across the Children’s Hospital Colorado system, we have hospitalized and cared for more than 2,000 children with COVID-19 since the start of the pandemic. Some of these cases have been severe, requiring care in our intensive care units. We know that with the delta variant and its increased transmissibility, this virus has impacted many more kids than at the start of the pandemic.”

Read more about the direct and indirect impacts of COVID-19 on children, from mental health challenges to multisystem inflammatory syndrome and more.

This has been a confusing time for all parents who have had to keep up with changing health guidance and the pandemic’s impacts on social activities, school and everyday family life. Now is the time for parents to speak to their child’s pediatrician about the COVID-19 vaccine to get their questions answered. Vaccines are the strongest layer of protection we can offer children against COVID-19.

Vaccines ‘nothing short of miraculous’

“When the pandemic hit in March of 2020, it was pretty clear to those of us in infectious disease that the only way out of this pandemic would be with vaccines,” said Sean O’Leary, MD, MPH, a pediatric infectious disease expert at Children’s Colorado and member of the CDC’s Advisory Committee on Immunization Practices. “What I've observed in the last 18 months with the development, authorization and distribution of these amazing, safe, effective vaccines is nothing short of miraculous. We were hoping for vaccines that were 50% effective, and we got vaccines that were more than 90% effective at preventing infection and even better at preventing hospitalization and death. These vaccines are a gift.”

Ahead of the EUA for kids ages 5 to 12, 72% of eligible Coloradans had been fully vaccinated. “This is remarkable, said Dr. O’Leary. “But we're not done yet. We need to finish that last mile to protect ourselves, our communities and our children.”

Vaccine rollout for children 5+

Children’s Colorado partnered with the State of Colorado to make vaccines for 5- to 11-year-olds easily accessible. In November and December 2021, Children’s Colorado hosted the Colorado Department of Public Health and Environment (CDPHE) at locations in Aurora, Broomfield, Colorado Springs and Highlands Ranch. These clinics were run by CDPHE, in addition to the hospital system's own clinics. In just over two months, the two organizations provided more than 36,000 doses to kids and families through this partnership. 

With the expanded availability of pediatric vaccine appointments, Children's Colorado transitioned from a mass vaccination model and now offers the COVID-19 vaccine through primary care.

Vaccine appointments

We encourage parents to learn more about the COVID-19 vaccines and speak with their child's pediatrician about getting vaccinated as soon as they become eligible.

Learn the top questions and answers about the COVID-19 vaccines

Find resources for getting vaccinated, transportation options and more

For the latest on what parents should know during the pandemic, please see our family-friendly COVID-19 resources.