Moderna is testing efficacy for age 6 months to 6 years, hoping to seek approval from Health Canada. Some parents have been eager to sign their kids up.
Lauren Socha knows there is a chance her toddler got the placebo instead of the COVID vaccine, but that day in January still felt like a “little bit of hope.”
There hasn’t been a lot of that since Arthur was born. Waves of the pandemic intensified and receded. Vaccines arrived in cargo planes, politicians posed on the tarmac. Most Canadians rushed to get their shots while others loudly objected. Vaccine rates for children over five stalled.
“If both of my kids could get vaccinated right now, I would not hesitate at all,” she says.
Kids under five are the only age group without vaccine access, as Canadians await the first approval for that cohort.
For Socha, a vaccine trial was the only way her son could get a shot at protection. (Her daughter is a newborn.)
She didn’t always feel this way. She had reservations at first because there were so many unknowns. The Moderna trial, KidCOVE, has been underway since March 2021, with more than 13,000 children between the ages of six months and 12 years enrolled across Canada and the U.S. The first phase in the U.S. determined the best dosage. The second phase is measuring the vaccine’s efficacy.
Socha felt better about her son joining the second phase. By late last year, she decided anything she could do to protect her family and friends was a good thing, and she signed him up for a Moderna trial at Sick Kids.
This past week, Moderna announced its vaccine trial for children between six months and six years met its main goal, with preliminary results showing “robust neutralizing antibodies” similar to the adult vaccine. The company will soon make regulatory submissions but Health Canada could not yet estimate when vaccines would be approved for the country’s youngest citizens.
The Canadian Moderna trials are mostly located in pediatric hospitals or universities. The outlier is the trial being run in a medical office in an unassuming shopping complex in north Etobicoke. This is where Dr. Anil Gupta has a family practice. Gupta is also a passionate researcher with close to 20 years’ experience running clinical trials.
Of the 129 participants in Gupta’s study, the majority are under six. Parents were motivated by a desire to protect their children, and also a desire to be part of the solution to this pandemic, he says.
It is a major commitment. Children are given two injections, 28 days apart. Ajay Chhabra, the “unblinded” study co-ordinator, is the only person who knows who has been given the placebo or the real thing. If the vaccine becomes available, participants can learn their status so they can ensure they are protected (When five-year-olds became eligible for the Pfizer-BioNTech vaccine, for instance, nearly all five-year-olds in the study found out their status.)
Families must make five trips to Gupta’s Etobicoke practice, where the children have nasal swabs every time, the two injections, and two blood draws. (They are compensated $60 for travel each time.) Caregivers record temperatures and symptoms on an app for a week afterward, with periodic updates every month. The clinical trial co-ordinator, Amisha Gandhi, keeps in touch with all of the families, sorting through their many schedules. Some families drove from Owen Sound and Barrie. “It wasn’t easy to do and yet, we could have recruited 500,” Gupta says. The trial is now closed.
Gupta practises in northwest Toronto, an area hit hard by COVID. While some of his own patients joined the trial, many of their parents were hesitant about the yearlong commitment, the blood draws, and potential side effects. (In Moderna’s preliminary results, the majority of adverse events were mild or moderate. There has been no myocarditis or pericarditis seen in the trial.)
In the end, many participants in Gupta’s trial were children of doctors. Most doctors learned about the trial through word-of-mouth and saw the benefit in making that decision for their children. (Older children in the trial were able to make the decision themselves.)
Since the trial began in August, Gupta and his staff have been working nights and weekends. “It was just an incredible amount of work,” he says. “Just an incredible effort.”
They have come to know the children well. One of the older kids wrote that even if they got the placebo version, that would be OK because they would be helping others. With the younger cohort, the trial started this fall. There was talk of “ouchies,” and some crying, but a “really minimal amount,” Gupta says.
In its recent update, Moderna noted that the Omicron variant was surging during this later phase of the study, so the vaccine had lower efficacy, which was expected and consistent with the adult experience. (Children under two showed 43.7 per cent efficacy, and the two-to-six group showed 37.5 per cent efficacy.)
Lauren Socha’s son got COVID during the Omicron wave, a week and a half after his first injection (which may or may not have been the actual vaccine). He had a low-grade fever but no other symptoms. Socha, who was triple-vaccinated, also got COVID. She has cystic fibrosis, and had been worried about how she would fare. Her symptoms were mild.
Dr. Anita Hickey, a child psychiatrist who lives in Holland Landing, tried to get her children into one of the Toronto trials for some peace of mind, but they were already full for toddlers, and her infant daughter didn’t meet eligibility requirements.
“I felt like it was my best chance at getting some protection for my kids quickly,” she says. Her mother is immunocompromised so they are especially careful. “There’s a degree of emotions that just start to play into your thought process,” she says. “It’s really hard for kids to live such a restricted life.”
Dr. Anne Wormsbecker, a consulting pediatrician at St. Michael’s Hospital and St. Joseph’s Health Centre, says some families have been “chomping at the bit to have this vaccine in the arms and thighs of their young children.” Others might be reluctant. In Ontario, uptake for COVID vaccines in the five-to-12 age group is only 55 per cent.
Children have been at lower risk during the pandemic, likely one reason for some parents’ hesitancy. However Canadian hospitals have seen increased pediatric admissions during Omicron. And children under five have been hospitalized at a much higher rate than during the Delta wave, according to a U.S. study by the Centers for Disease Control.
Wormsbecker said a vaccine will go a long way toward boosting equity. Some families have held off on daycare, and many children have missed learning and social opportunities. Vaccination status could lead to changes in daycare policies, which would make a “huge difference for families.”
“Children have borne a huge and unfair burden of the public health response to the pandemic, especially in Ontario,” she says. “We know the early years are so crucial for children attending child-care programs, extracurriculars, parent and child groups, as well as school. Getting them back to their regular lives is a huge priority for their growth and development, especially as we move to a next phase of the pandemic with fewer public health restrictions in place.”
Article From: The Star
Author: Katie Daubs