Experts urge vaccination trials begin for children

For more than half his life, Alexandra Haake Kamberos’ 18month-old son has lived under quarantine conditions.

As a result, otherwise typical occurrences, like indoor playdates and trips to the grocery store, aren’t a regular parto f the Chicago boy’s life right now, his mother said.

While people around theworld wait for the authorization and distribution of COVID-19 vaccines that will eventually allow for a return to normal life, young children may have towait longer. That is spurring an urgent cry from pediatricians to include these children in trials to reduce their delay in becoming vaccinated.

Children under 12 have not been part of the U.S. trials for vaccines that are showing promising results against the virus, which has infected more than 759,000 people in Illinois and killed more than 12,000 statewide since

“We’re not going to reach herd immunity … until children are immunized as well.” — Dr. Elaine Rosenfeld, pediatric infectious disease specialist for Advocate Children’s Hospital in Oak Lawn

March.

That means vaccines will likely be available for the general population of adults months before they are available for children because the trials need to be replicated with children as the test subjects, experts said.

“If we do not add children to these research trials very soon, there will be a significant delay in when children are able to access potentially lifesaving vaccines. This is unconscionable ,” said American Academy of Pediatrics President Dr. Sally Goza in a statement released last month by the Itasca-based association.

Though teens and tweens have been part of major vaccination trials — Pfizer has included children 12 and older, and The New York Times reported that Moderna would begin trials for children between 12 and 17 — doctors say the studies need to start including children under 12, and are calling with increasing urgency for those trials to begin.

A Pfizer spokesperson said in a statement to the Tribune that the company is “working actively with regulators on a potential pediatric study plan” to address the disease in children under 12. Moderna did not respond to a request for comment from the Tribune.

Goza sent a letter to U.S. Department of Health and Human Services Secretary Alex Azar in October to stress the importance of including children in the trials, writing that more than 587,000 COVID-19 cases have been reported in children in the United States, including in 109 who have died.

“Children are not just little adults,” said Dr. Elaine Rosenfeld, pediatric infectious disease specialist for Advocate Children’s Hospital in Oak Lawn, echoing the AAP’s urgency in the need for pediatric trials. “It’s going tobe necessary to perform clinical trials on the pediatric population.”

Rosenfeld said the trials will not only indicate whether the vaccine is as safe and effective in children as it is in adults and teens, it will offer important information like proper dosing for children.

Though children generally become less sick with the virus, Rosenfeld said there are cases in which children experienced dangerous complications, such as multisystem inflammatory syndrome, which can cause body parts, including the heart and lungs, to become inflamed.

Children can also transmit the virus to adults, who may become more sick.

“We’re not going to reach herd immunity … until children are immunized as well,” Rosenfeld said.

Chicago public health Commissioner Dr. Allison Arwady has said the city plans to distribute its first doses of vaccine to health care workers in the city in December, followed by people in other high- risk groups as the health department receives additional doses.

During a virtual question-and-answer session Tuesday, Arwady estimated that the general population might begin to receive vaccinations in the spring, with children following in the summer, though she cautioned, “I almost feel like it is foolish to make predictions at this point.”

“A lot of that is just dependent on vaccine production and how well the vaccine trials do,” she said.

That puts parents like Haake Kamberos in an uncertain position. She plans to send her son to nursery school when he is around 2, but that is subject to change.

Her family recently had a scare when their nanny experienced some symptoms, though she later tested negative.

“Everyone had to stay home,” she said.

Still, she will feel better when the adults around her son can be vaccinated, at least reducing the risk of exposing him.

Chicagoan Paula Calpo, mother of a 15-month-old girl, is eager for a vaccine and hopes one is available for children soon.

“I’m just ready to stop this,” Calpo said.

Calpo is from Brazil, and close family members haven’t been able to see her daughter since she was 3 months old, before the pandemic began. Now, travel would be off-limits.

“We’re far away from family,” she said. “It’s a hard time.”

Though it’ s normal to test medications on adult populations first, pediatricians say it is safe to begin trials on children, noting that all the long-approved vaccines people take in childhood were once tested on children.

“I feel really confident that these trials ina younger population will be done safely because of the history of vaccine trials in children,” Rosenfeld said.

Still, doctors worry about the impact of anti-vaccination movements that eschew scientific evidence and, in recent years have coincided with the resurgence of contagious diseases like measles.

In her letter to the Department of Health and Human Services, Gozacited concerns about misinformation spread by such antivaccination movements.

“It’s very concerning to us that people do not have the trust inscience that they used to,” Goza told the Tribune. “We need to build that trust back.”

Goza, who is also a pediatrician in Georgia, said she knows parents may be nervous due to the speed at which scientists developed the vaccine, but pointed to robust financing efforts that sped up the process. And she assures people that the process for approval, though accelerated, has been the same as for prior vaccines.

Still, trials must begin on younger children before they can be vaccinated safely, Goza said.

Rosenfeld said pediatricians’ offices have been inundated with calls from parents asking about the vaccine, indicating to her a high interest in obtaining the vaccine for their children.

“I think it’s time to get moving on (the trials), aswe know it takes a while to get kids vaccinated properly,” she said.