An elementary school boy came to every appointment in a kid-sized lab coat, a children’s book about mRNA vaccines in his arms. Another child announced she was “helping science.” And Kaniya Smith told her friends in the fourth grade that she was taking the coronavirus vaccine to test it out for the rest of them.
The parents of more than 5,000 kids from Colorado and beyond applied to take part in the world’s largest Pfizer COVID-19 vaccine trial for children ages 5-11. A fraction of them — 252 — were chosen to participate in the trial held last spring at Children’s Hospital Colorado in Aurora, which was selected as the pharmaceutical company’s “supersite” for the historic research.
Now, the hospital has turned over its results to Pfizer, and parents across the nation await 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, operating under an energy not lost on the kids taking two doses in their arms, three weeks apart. “This is once-in-a-lifetime type work. It was our big time,” said Erin Sandene, director of research and operations at the Research Institute at Children’s Hospital Colorado.
Children’s was picked based on its long-standing reputation for conducting pharmaceutical trials and because the Aurora campus already had freezers that dropped below negative 80 degrees, the temperature required for vaccine storage. Two-thirds of children received the vaccine, while one-third received a placebo — and families are still waiting anxiously to find out which one their kid received.
Pfizer and its German partner, BioNTech, have compiled the results of the Children’s trial and about 90 smaller trials across the nation, and Pfizer announced that the vaccine produced a robust antibody response.
Kaniya, 10, said she was proud to play a part in history, once she got past the needle that came with the blood draw to check her antibody levels. “I was pretty nervous,” she said. “Mom and Dad got me through it, though. They just talked to me and said, ‘This is gonna be OK’ and ‘You are one of the first people to get to do this.’”
Kaniya’s mom, Key Williams, is now waiting to find out whether her daughter was actually vaccinated during the study. If Kaniya received a placebo, she will be at the top of the list for a vaccine if and when it’s approved by the FDA.
Williams, of Centennial, applied for a spot for Kaniya soon after hearing an ad on the radio while driving to her sales job. While most of her friends and coworkers are proud of Kaniya for “being a big girl and getting it done,” Williams said she has heard judgy comments from others whom she suspects wonder why she wanted her child to test out a new vaccine. “I’m hearing everything from ‘They are putting chips in us’ to ‘They’re turning us into zombies,’” she said of the conspiracy theories about the vaccine that have circulated online and at work. Williams was not deterred.
“I feel very blessed for being able to be a part of this,” she said.
For seven days after each shot, Williams and other parents involved in the trial entered any symptoms or reactions into an electronic diary. Kaniya vomited once, but Williams suspects it was something she ate. For the next two years, trial participants are asked to enter data into the diary app weekly so that researchers can track long-term results and adverse events.
“It could be someone has a nose bleed six months out,” Sandene said. “We have to document that because what if 20 people had a nose bleed?”
To pull off the trial, the hospital needed about 20 nurses who worked with kids and their parents, talking them through the process, teaching them to use the diary app and handling blood draws, nasal swabs and the injections. It was a “blind trial,” meaning the nurses who worked with families did not know which kids were getting the vaccine and which ones were getting the saline placebo. Only one nurse, the one who was in the room with families for just long enough to give the injection, knew whether she was holding a placebo or a vaccine.
All of the nurses involved were women, said Sandene, a nurse who now oversees about 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 was a morale boost at a time when health workers everywhere are burned out by the pandemic, she said. “Without these clinical research nurses, there is no way we could have done 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 doing clinical research, typically working on hundreds of smaller trials at once throughout the hospital. They monitor and track new drugs and new devices, following required protocols to draw blood every 30 minutes or every hour, and logging all the side effects.
Children’s did not apply to oversee a trial of the Moderna vaccine for kids because the hospital wanted to give its “beautiful all” to the Pfizer trial, Sandene said. “It was a huge undertaking.”
Becky Howard, a clinical research nurse who helped run the trial, said it was quite out of the ordinary to see patients who were excited to get a shot. She recalled children saying, “I hope it’s the real thing. I hope it’s the vaccine.”
“Having kids who were just thrilled to get an injection is not what you usually see,” Howard said. “We were hoping we could get the opportunity to do something like this. It’s amazing to think about the sheer volume of patients that we were able to enroll and see, just given the urgency of what we were working with.”
From the start, Children’s pledged to enroll children in the trial who matched the diverse makeup of the neighborhood surrounding the hospital east of Denver. Aurora is about 17% Hispanic and 16% Black, and also is home to immigrants from across the world. The 252 children selected were 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 families who were selected, and involved “child life specialists” and play therapy for children with autism or mental health issues.
“We were extremely thoughtful about that,” Sandene said, noting that historically, clinical trials are made up mostly of white, upper-middle-class children. “We didn’t want it to be 70 doctors and their 280 children.”
Most of the children were from Colorado, but the trial also included kids from other western states.
Worldwide, the Pfizer trial included 2,268 children, all of whom received two doses of 10 micrograms each, which is one-third the size of the dose for adults and teens. The Biden administration announced last week that it has purchased 65 million pediatric doses of the vaccine, enough to vaccinate the estimated 28 million children who would be eligible.