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
A school-aged boy wears a cloth face covering with a teddy-bear print

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 better we can protect our community and 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 putting this pandemic behind us. We encourage everyone to learn about the COVID-19 vaccines and get vaccinated as soon as they are able, and we look forward to helping vaccinate the children in our community.”

With the eagerly anticipated recommendation of the Pfizer-BioNTech 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.

Vaccine appointments for children 5+

Children’s Colorado has partnered with the State of Colorado to make vaccines for 5- to 11-year-olds easily accessible. Children’s Colorado will host the Colorado Department of Public Health and Environment (CDPHE) at locations in Aurora, Broomfield, Colorado Springs and Highlands Ranch. These mass vaccination clinics are entirely administered by CDPHE.

CDPHE vaccine clinics at Children’s Colorado

CDPHE’s first recurring clinics began Friday, November 5 at the following Children’s Colorado locations:

  • Children's Hospital Colorado, Anschutz Medical Campus: Fridays, Saturdays and Sundays
  • Children's Hospital Colorado, Colorado Springs: Fridays, Saturdays and Sundays
  • Children's Hospital Colorado, North Campus: Mobile clinic, 3 days per week, dates vary
  • Children's Hospital Colorado, South Campus: Mobile clinic, 3 days per week, dates vary

These appointments must be made through CDPHE. Note: Unlike at Children’s Colorado, scheduling is required for both first and second doses; parents should book two appointments, at least 21 days apart.

Visit CDPHE’s website for details on vaccines for children and teens and a complete list of vaccine providers across Colorado. Vaccines are free, and no identification, proof of residency or insurance is required. For questions, call the state vaccine hotline at 1-877-268-2926.

Appointments at Children’s Colorado for 5+ now open

On November 12, Children’s Colorado opened its own vaccine clinics for patients and children ages 5 to 11 at hospitals in Aurora and Colorado Springs.

See all COVID vaccine appointment options at Children's Colorado

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. With the EUA for children 5 and older now in place, trial participants are being “unblinded,” and participants who received the placebo have been invited to receive the vaccine at Children’s Colorado. Our trial team is scheduling appointments with placebo participants directly; they should not schedule appointments elsewhere.

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: benefits of Pfizer’s COVID-19 vaccine outweigh risks for kids 5+

The FDA and CDC analysis of Pfizer-BioNTech’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 in respiratory distress – that means 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.”

Learn more about how the COVID-19 vaccines were developed.

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.”

Our role in vaccine distribution

Beginning in December 2020, Children’s Colorado partnered with CDPHE to help vaccinate healthcare providers, first responders, teachers and teenage patients at high risk from COVID-19. Between April and June 2021, the pediatric health system’s vaccine clinics opened to the public while the State of Colorado ramped up supply and distribution. With the expanded availability of the COVID-19 vaccines, this summer Children's Colorado transitioned from a mass vaccination model and is now focused on vaccinating the pediatric population.

“We are immensely proud of our team members, who served our community and vaccinated more than 50,000 individuals against COVID-19 since the vaccines first became available,” said Dr. Brumbaugh. “Now we’re thrilled to partner with CDPHE to host their clinics and offer thousands of vaccine appointments for children ages 5 and older at locations throughout the Denver Metro Area and Colorado Springs.”

Additional vaccination sites

The COVID-19 vaccines are now widely available in the community. While Children’s Colorado remains focused on vaccinating children, we encourage adults who haven’t been vaccinated yet to learn more about the COVID-19 vaccines and speak with their primary care provider about getting a vaccine. It takes all of us to slow the spread of COVID-19 and bring an end to the pandemic.

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

Find resources for getting vaccinated, transportation options and more

Preventing the spread of COVID-19 is still critical

Remember, stopping a pandemic requires using all the tools available to us. To slow the spread of COVID-19 and new coronavirus variants, we should continue taking precautions, including, wearing face coverings indoors, avoiding crowds and washing our hands frequently and thoroughly, even after receiving a COVID-19 vaccine. We must continue to take these precautions until and the majority of the population, including most children, has been vaccinated.

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