Colorado Children’s Hospital Was Historic Vaccine Trial “Supersite”


An elementary school student came to each appointment dressed in a child-sized lab coat, a children’s book on mRNA vaccines in his arms. Another child announced that she was “helping science”. And Kaniya Smith told her fourth-year friends she was taking the coronavirus vaccine to test it for the rest of them.

Parents of more than 5,000 children in Colorado and beyond have asked to participate in the world’s largest Pfizer COVID-19 vaccine trial for children ages 5 to 11. A fraction of them – 252 – were chosen to participate in the trial held last spring at the Colorado Children’s Hospital in Aurora, which was chosen as the pharmaceutical company’s “supersite” for historical research.

Now the hospital has turned its results over to Pfizer, and parents across the country are awaiting a decision from the Food and Drug Administration, which is expected by mid-November.

An army of clinical research nurses who organized and ran the trial called it their Super Bowl, running undisturbed energy on kids taking two doses in their arms, three weeks apart. “It’s a one-time job in a lifetime. It was our highlight, ”said Erin Sandene, director of research and operations at the Children’s Hospital Colorado Research Institute.

Children’s was chosen because of its long-standing reputation for conducting pharmaceutical trials and because the Aurora campus already had freezers that dropped below 80 degrees negative, the temperature required for vaccine storage. Two-thirds of children have received the vaccine, while one-third have received a placebo – and families are still anxiously waiting to find out which one received their child.

Director of Research Operations Erin Sandene and Clinical Research Nurse Becky Howard pose for a portrait Thursday, October 14, 2021 at the Anschutz Colorado Children’s Hospital in Aurora. (Olivia Sun, The Colorado Sun)

Pfizer and its German partner, BioNTech, have compiled the results of the trial in children and about 90 smaller trials across the country, and Pfizer announced that the vaccine produced a strong antibody response.

Kaniya, 10, said she was proud to play a part in the story, once she stepped past the needle that came with the blood test to check her antibody levels. “I was pretty nervous,” she said. “But mom and dad got me through this. They just talked to me and said, ‘It’s going to be fine’ and ‘You’re one of the first people to do this.’ ”

Kaniya’s mother, Key Williams, is now waiting to find out if her daughter was actually vaccinated during the study. If Kaniya was given a placebo, she will top the list for a vaccine if and when it is approved by the FDA.

Williams, of Centennial, applied for a position for Kaniya shortly after hearing an ad on the radio as she walked to her sales job. While most of her friends and colleagues are proud of Kaniya for “being a big girl and doing it,” Williams said she heard some insightful comments from others who she believes are falling into place. ask why she wanted her child to test a new vaccine. “I hear everything from ‘They put chips on us’ to ‘They turn us into zombies’,” she said of the vaccine conspiracy theories that have been circulating online and at work. Williams was not deterred.

“I feel very blessed to be able to be a part of this,” she said.

For seven days after each injection, Williams and the other parents involved in the trial recorded any symptoms or reactions in an electronic journal. Kaniya threw up once, but Williams suspects it was something she ate. Over the next two years, trial participants are asked to enter data into the diary app every week so researchers can track long-term results and adverse events.

“It could be someone with a nosebleed in six months,” Sandene said. “We have to document this because what if 20 people had nosebleeds? “

To carry out the trial, the hospital needed around 20 nurses who worked with the children and their parents, teaching them through the process, teaching them how to use the diary app, and how to manage the medication. blood, nasal swabs and injections. This was a “blind test,” meaning nurses who worked with families did not know which children were getting the vaccine and which were getting the saline placebo. Only one nurse, the one who was in the room with the families just long enough to give the injection, knew whether she was holding a placebo or a vaccine.

Kaniya Smith, 10, with Tigger at her home on Thursday October 14, 2021. Kaniya’s mother, Key (not pictured) heard about the Pfizer vaccine trial through a radio commercial and listed her girl. (Olivia Sun, The Colorado Sun)

All of the nurses involved were women, said Sandene, a nurse who now supervises around 100 people at the hospital. “Ninety-five percent of the work done in a clinical trial is not done by a doctor,” she said. Despite the long hours, the vaccine trial has lifted morale at a time when health workers around the world are exhausted by the pandemic, she said. “Without these clinical research nurses, we would never have been able to do a trial. There is a huge group of women doing all the planning.

Eight of the nurses involved in the Pfizer trial work full-time in clinical research, typically working hundreds of smaller trials at a time across the hospital. They monitor and keep track of new drugs and devices, following the protocols required to draw blood every 30 minutes or every hour, and recording any side effects.

Children’s did not apply to oversee a trial of the Moderna vaccine for children because the hospital wanted to give the Pfizer trial its “good looks”, Sandene said. “It was a huge undertaking.”

Becky Howard, a clinical research nurse who helped run the trial, said it was quite unusual to see patients thrilled to be vaccinated. She remembered children saying, “I hope this is the real thing. Hope this is the vaccine.

“Having kids who were just thrilled to get an injection isn’t what you usually see,” Howard said. “We were hoping to have the opportunity to do something like this. It’s amazing to think of the sheer volume of patients we were able to enroll and see, given the urgency of what we were working with.

From the start, Children’s was committed to enrolling children for the trial who matched the diverse makeup of the neighborhood surrounding the hospital in east Denver. Aurora is approximately 17% Hispanic and 16% Black, and is also home to immigrants from around the world. The 252 children selected made up an even more diverse pool than the city’s demographics, Sandene said.

Advertising for the trial was in English and Spanish, and Children’s asked community health care providers, including the safety net clinic Salud Family Health Centers, to talk to their patients about the research. The hospital used Korean, Japanese and Spanish interpreters to communicate with some of the selected families, and involved “child life specialists” and play therapy for children with autism or problems. mental health.

“We’ve been extremely careful with this,” Sandene said, noting that historically, clinical trials have mostly consisted of upper-middle-class white children. “We didn’t want it to be 70 doctors and their 280 children.

Most of the children were from Colorado, but the trial included children from other Western states as well.

Worldwide, the Pfizer trial included 2,268 children, all of whom received two doses of 10 micrograms each, or one-third the dose for adults and adolescents. The Biden administration announced last week that it had purchased 65 million pediatric doses of the vaccine, enough to immunize the 28 million children who would be eligible.

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