In recent weeks, Ontario’s COVID-19 vaccine rollout has made significant progress, with efforts shifting to reach eligible stragglers and those left behind. Just one population remains barred from the much-coveted jab in the arm: children under 12.
But with a return to schools in September expected to include the resumption of extracurricular activities, as well as loosened rules on masking and distancing, parents have asked: will young children be eligible for vaccination in the fall? Based on existing data, should they be?
Dr. Ari Bitnun, a pediatric infectious diseases physician at Sick Kids, said to justify vaccinating young children, who usually show very mild symptoms, if any, when infected, the vaccine must be safe. Taking time to develop strong safety data before jabs become widely available to kids will give Ontarians more confidence.
“Because those studies haven’t been completed or published, it’s too early,” Bitnun said.
In a randomized trial, children and their families are approached about participating, and can consent after being walked through pros and cons. That could differ from a general rollout to the public, Bitnun said.
Dr. Jeffrey Pernica, head of the division of pediatric infectious disease at McMaster Children’s Hospital, shared the sentiment.
Because COVID in children is “by and large, a mild illness,” and they’re not at “substantially increased risk,” the “harms of missing school far outweigh the potential harms of the acquisition of COVID,” he said.
Kids have faced academic, psychological and social-developmental losses; eating disorder admissions increased and mental health problems have skyrocketed, Pernica added. The children with the most to lose from schools being shut are from marginalized and low-income backgrounds, he said.
“It’ll be important for children and adolescents to get back to school in the fall, regardless of whether or not they are vaccinated,” Pernica said.
Pfizer aims to file data from Phase 2 and 3 studies on the safety and efficacy of its COVID vaccine to Health Canada “before the end of the year to support a potential authorization” in children 5-11, and shortly after for six months to five years, Christina Antoniou, a Pfizer spokesperson, said Wednesday.
“We have been working closely with Health Canada and submitting to them new data regarding this vaccine when it becomes available. We plan to do the same with any new data from these pediatric studies.”
The manufacturer’s plan for submitting the vaccine for potential emergency use authorization to the U.S. Food and Drug Administration is more clear: “sometime in the September to October time frame” for the same age groups.
Peter Marks, the director of the Center for Biologics Evaluation and Research within the FDA, said emergency authorization and availability of the Pfizer vaccine in the U.S. for children under 12 could come by “the fall to winter timeline,” in a May 27 interview with BlackDoctor.org.
When asked how long Health Canada may take to approve a vaccine for under-12s, after receiving results of clinical trials, a department spokesperson said “the time it takes to authorize a COVID-19 vaccine or treatment varies.”
Authorization depends on many factors, “including the need for additional data, discussions with the sponsor and other requirements such as updates to safety information,” the spokesperson added.
Health Canada is still reviewing Moderna’s submission to expand the vaccine to children 12 and older, which it received June 4. The review is expedited, but Health Canada “cannot provide specific timelines.”
Before submitting the vaccine to any health authorities, Pfizer and its partner BioNTech will need to confirm the “safety, tolerability and immunogenicity” — how well a vaccine works — in children five to 11, Antoniou said. Studies on the effect on kids as young as six months to five years have yet to begin, but will “soon.”
The completed Phase 1 of the pediatric study allowed Pfizer and BioNTech to “understand the optimal dose of the vaccine” for kids five to 11, two to five, and six months to two years, Antoniou said.
Based on results from Phase 1 trials, a dose of 10 micrograms was selected to advance into phases 2 and 3 for kids five to 11. A dose of three micrograms was selected for kids from six months to less than five years. Each dose of Pfizer’s jab for adults contains 30 micrograms of the vaccine.
Children’s vaccine dosing needs are different from adults, Bitnun explained.
“It’s not just that they’re physically smaller, but their immune system is younger … you’ll have lower doses than what was used in adults or in teenagers,” he said.
Both Bitnun and Pernica cited rare reports of mostly mild heart inflammation in youth following vaccination as one reason to proceed with caution. “That wasn’t anticipated,” Bitnun said. “We hadn’t seen it in the adults, and all of a sudden we saw it in the kids.”
“It seems to be much more common in teenagers than older adults, and in teenage boys especially,” Pernica said. “We don’t know whether or not this will also be true in children under 12.”
In the U.K., the government has decided not to immunize most under-18s, awaiting more data. Those 12-15 with severe neuro-disabilities, Down syndrome, immunosuppression and multiple or severe learning disabilities, will be eligible, Public Health England said. As well, young people 12-17 who live with an immunosuppressed person will be eligible. Teens aged 16 and 17 with underlying conditions have already been offered shots.
However, the vaccines were found to be effective in teens; that’s why they were approved, and why teens should be vaccinated, Pernica said. In fact, mRNA vaccines, like Pfizer and Moderna, work even better in teenagers than adults, he added. They will probably work well in children, but it’s possible the adverse events of the mRNA vaccines in younger children will differ from those seen in adults, Pernica said.
Meanwhile, infants need more doses and to be boosted after the age of a year “for almost every vaccine that we have,” he said. For COVID, it’s something that will need to be examined within the context of a trial.
“Every decision in medicine is benefit versus risk … there is a dramatic benefit of COVID vaccine in adults … the younger people are, the less they have to fear COVID,” Pernica said. “So you have to pay more attention to even small risks associated with the vaccine.”
As of Thursday, almost 80 per cent of Ontarians over 12 have received at least one dose; nearly 64 per cent have two doses.
In mid-June, 232 active COVID cases were detected in the remote northeastern First Nation of Kashechewan. The majority of infections were among children under 12 who can’t be vaccinated, and teenagers who had either not been vaccinated or had just one dose.
To protect children under 12 from catching COVID, especially with schools reopening in the fall, the province should focus on reaching vaccine stragglers and target eligible people who are still hesitant, Bitnun said.
Article From: The Star
Author: Maria Sarrouh
