CHICAGO — Eight-year-old Gabriel Gometz was anxious before getting a shot on a recent weekday at Lurie Children’s Hospital, peppering his parents and health care workers with questions about how big the needle would be and how much the injection might hurt.
“It’s not that bad,” said his sister Juliana Gometz, 11, who had received her first dose minutes before. “You have to just do it.”
The little boy finally rolled up his sleeve and held onto his dad, looking away as the needle went into his upper arm. When the jab was over, his family and several hospital workers erupted in applause, their claps and cheers reverberating off the walls of the small exam room.
That injection was a milestone of sorts, marking one small step in the lengthy and tedious process of getting a COVID-19 vaccine authorized for children under 12.
The Gometz kids are volunteers in a Moderna vaccine study underway at Lurie, testing the safety and effectiveness of the shot in children ages 6 to 12. So far, about five dozen children are participating in the study at Lurie. The brother and sister received their first doses at the hospital last week.
While Gabriel and Juliana were both nervous about getting their shots — as well as the multiple rounds of COVID-19 tests and blood draws required for the trial — both expressed excitement at being a part of the study. The kids proudly told all their friends during their first week at school about their participation in the trial, said their mom, Shannon Lightner-Gometz.
The chance to potentially get inoculated against the virus earlier, as well as help move the vaccine closer to market for other children their age, far outweighed their unease about getting poked and prodded, she said.
She added that the immunization had already been given to millions of adults as well as many kids just a little older than her own, so the risk of entering her son and daughter in the trial seemed minimal compared with the benefits. The Gometz family, who live in the Bronzeville neighborhood, were also enthusiastic for an opportunity to help fight the pandemic.
“There’s the possibility they’ll receive the vaccine,” Lightner-Gometz said, noting that there’s a possibility her kids received a placebo during the trial. “But it’s also the beacon of hope that things are moving forward.”
As many parents eagerly await the moment a COVID-19 vaccine becomes available for young children, the pandemic continues to rage across the country, with a recent surge in cases among kids.
Nearly 204,000 pediatric cases were reported late last month in the United States, a more than fivefold increase in the past month, according to the Chicago-based American Academy of Pediatrics; almost 4.8 million kids have tested positive for the virus nationwide since the pandemic began, as of Aug. 26.
While the Pfizer vaccine is authorized for children as young as 12, none of the three COVID-19 immunizations used in the United States are available to younger kids, leaving millions of children unprotected against the virus.
But before a vaccine can be authorized for younger age groups, it must be tested on thousands of trial participants like Gabriel and Juliana.
Roughly 3,000 children are taking part in the Moderna trial at about 100 pediatric study sites across the United States and Canada. Thousands more volunteers aged 5 to 12 are participating in similar studies of the Pfizer vaccine, which is a little further along.
Dr. Scott Gottlieb, former head of the Food and Drug Administration and a member of Pfizer’s board of directors, recently estimated on the CBS program “Face the Nation” that the Pfizer vaccine might be available to children younger than 12 as soon as early winter.
The FDA in July asked Pfizer and Moderna to expand the size of their clinical trials for kids in this age group as a precaution to help detect potential rare side effects to the vaccine in young people, such as heart inflammation conditions.
For the study at Lurie, patient recruitment began in the winter and the first shots went into arms in late August; the hospital is still recruiting participants.
While much of the nation is growing impatient for a COVID-19 vaccine for younger kids, medical experts say they must take exceptional care during studies involving children, because their health is paramount.
“The reason that studies move slowly, and the reason that we are very cautious with children, is that safety is the No. 1 endpoint for every study that we do,” said Dr. Bill Muller, professor of pediatrics at Lurie Children’s Hospital and an infectious disease specialist. “We of course are very motivated that it’s something that’s beneficial. But safety is the first priority.” Safe, healthy, thriving
Like so many families, the pandemic has been stressful for Tzeittle Gonzalez and her two young daughters, who live in the Bucktown area.
The abrupt switch to remote learning in March 2020 was difficult for all three of them. Music lessons were upended. After-school drama classes suddenly ceased.
Nine-year-old Gia and 6-year-old Eden longed for their teachers and friends, particularly the younger daughter who was in day care when lockdown started and didn’t have many outlets for interaction with other kids.
“‘I don’t have any friends’ was something I heard often,” Gonzalez recalled. “I want my kids to be healthy and protected, but I also want to make sure that socially and emotionally, they are thriving as well. And it’s hard to do that at home from a computer screen.”
When she learned of the vaccine trial at Lurie, Gonzalez said, she jumped at the opportunity to have her daughters take part. She was elated midsummer when she found out both daughters were selected.
The mom knows there’s some inherent risk in volunteering in a study for a vaccine that’s still considered unproven in her daughters’ age category. But she feels the potential benefits for her kids — as well as other children their age when the shot is finally granted emergency use authorization — far exceed possible threats.
Gonzalez added that her daughters are also at a higher risk of getting COVID-19 without vaccination, and there’s no way of knowing if they might suffer long-term damage or illness from the virus.
“We’re a very pro-health household,” she said. “We do vaccines. We’re just very comfortable with that.”
Trial participants have a 3-in-4 chance of receiving the Moderna vaccine, with the fourth patient getting a placebo shot as a control, said Muller, the infectious disease expert from Lurie.
The patient who receives the placebo is chosen randomly and it’s a blind study, so kids and their parents won’t know whether the patient has received the vaccine or a saline solution until the trial is done or a COVID-19 vaccine is authorized by the FDA; at that point, volunteers would be able to get the available vaccine if they were given a placebo during the trial.
First doses are being given to volunteers and second doses will follow a few weeks later. Participants will return for inpatient appointments and there will be additional phone interviews. The patients and their parents will also fill out questionnaires about their health, and any side effects they might experience, on an app.
Muller said the study is currently focused on elementary school-aged kids, but will later shift to younger children.
More than 100 lawmakers across the country signed a letter in mid-August pressing the FDA to provide a timeline for the authorization of vaccines for younger children, citing the “alarming” state of the pandemic for the parents of school-aged kids. After the vaccine receives emergency use authorization for this age group it will be available for younger children, but more study will have to be done before it gets approved for this population by the FDA.
“In some states, the number of children hospitalized with COVID-19 is higher now than at any other point during the pandemic,” said the letter, which was co-signed by several local legislators, including U.S. Rep. Danny Davis, D-Chicago, Rep. Jan Schakowsky, D-Evanston, and Rep. Lauren Underwood, D-Naperville. “This surge and the rise of new, more dangerous variants is coming right as the school year begins, as temperatures drop, and as more parents are required to return to in-person work.”
The American Academy of Pediatrics has also urged the agency to work “aggressively” to authorize the shots for kids under 12.
“The higher proportion of cases in this population means this age group could be contributing in driving continued spread of COVID-19,” the AAP said in a July letter to the FDA.
Like most Chicago Public Schools students, Gia and Eden started school in person, full time on Monday for the first time since the pandemic began. The majority of students in their school are too young to get vaccinated.
“There’s nothing for them but a mask,” Gonzalez said. “It’s scary.”
The transition back has been nerve-wracking for many parents who were concerned for the safety and health of their kids, particularly due to the highly infectious delta variant of the virus that’s circulating across the country.
An authorized vaccine could make all the difference for elementary school-aged kids, Gonzalez said.
“It will open up the world, I hope,” she said. ‘Security and hope’
Gabriel Gometz had nightmares during the first few months of the pandemic.
His dad is a geriatrician at Rush University Medical Center and serves as the medical director of a nursing home. Dr. Edward Gometz had feared for his patients, who were among the most high-risk and vulnerable.
“The news was on all the time,” Lightner-Gometz said. “Especially early on, we were all trying to understand how bad this was going to get, and who it was going to impact, and what the rates were and what the levels were.”
So much was unknown at the time. Could the virus be contracted through surface contact? How long did it linger? To be safe, the father wouldn’t let his kids touch him until he showered after returning home from work at night.
“Am I going to die of COVID?” the little boy would ask. “Is Daddy going to die of COVID?”
Going back to school in person last year relieved some of his apprehension and helped both kids return to a routine and sense of normalcy, Lightner-Gometz said.
When her husband got vaccinated against COVID-19 in December, much of Gabriel’s fear subsided, she recalled. The young boy no longer expressed worry when his dad left the house for work.
“This whole time, my son’s been begging for a vaccine,” she said. “He saw my husband get vaccinated and he felt better. He saw me get vaccinated and he felt better. I think he just feels like there’s security and hope in that.”
To calm Gabriel’s nerves before the boy received his first trial injection, the dad showed his son a picture of his own COVID-19 vaccination from December.
Gometz had posted the photo on Twitter, under the caption in Spanish indicating that he’s a Latino physician receiving his immunization and “delighted to do what I can to eliminate this pandemic.”
He wanted to encourage his patients to get the shot as well, and about half of them are Spanish-speaking. He also was aware that coronavirus hospital and death rates were significantly higher for Black and Latino patients, according to Centers for Disease Control and Prevention data.
In selecting trial participants, Moderna wanted to make sure the study represented the American population in terms of race and ethnicity, Muller said.
“Underrepresented minorities are also underrepresented in clinical trials, “ he said. “There’s historical reasons about the difficulties in people’s access to care and exploitation of people who have been involved in studies in the past, where there’s a general distrust of the medical system. And those are all things that we as an organization and the research community in general are trying to work on.”
He said Lurie went even further, evaluating the local areas that had been hardest hit by COVID-19, according to CDC and local health department data, and prioritizing study volunteers who live in those spots.
“We thought it was going to be more ethical and equitable to offer participation in this study preferentially to people whose communities were most affected by the pandemic,” Muller said.
He added that a pediatric trial also has to tailor the experience for younger children, explaining the process in a manner kids can understand and using tools to make the study the least-distressing experience possible.
“We filter developmental stage through any question we ask,” Muller said.
For example, a child aged 10 or 11 might understand the nature of a medical study, but a 6-year-old might not be able to grasp that concept, he said.
Pain management tools like Buzzy products — small, high-frequency vibrating devices shaped like bees or lady bugs — are sometimes used to reduce pain and distract a child’s attention from the injection.
“At a basic level, every time we provide medical care to a child ... we need to recognize what a privilege it is for parents to allow us to take care of their children,” Muller said. “For a study, that’s one step further, where someone is allowing you to do something that is unproven that involves their children. They’re making this decision to entrust the care of their child to you knowing that you have safety in mind, and you have the best interest of their child and society in mind. That is not lost on us.”