As Canada slowly transitions into more relaxed COVID-19 protocols and with summer well underway, all eyes are on the continued national vaccine rollout efforts.
Anticipating a return to in-class learning in September, parents are waiting to hear when children under 12 will get their turn to be vaccinated – but that may not be an option until next year.
In an emailed statement to CTVNews.ca Monday, the Public Health Agency of Canada (PHAC) acknowledged that “all manufacturers of the COVID-19 vaccines authorized in Canada are conducting or planning studies in adolescents and younger children,” and that the organization expected data “in the coming months.”
“At this time, no submission has been received for the approval of any COVID-19 vaccine in children under 12 years of age,” the statement reads.
Both Pfizer and Moderna have begun clinical trials of their COVID-19 vaccines in children as young as six months old, with Pfizer expecting first results in July and full results in September. The company said it hoped to see younger children getting vaccinated in early 2022.
Dr. Caroline Quach, chair of Canada’s National Advisory Committee on Immunization, has echoed that estimate, saying that a vaccine for younger kids isn’t expected until 2022 but some health experts hope that timeline will be moved up.
“When Pfizer’s vaccine data becomes available in the fall – and it looks good that for the five-to -11-year-old age group they’ll make their announcement probably in September, and then for the younger kids, hopefully we’ll see the data by November,” said Toronto physician and clinical researcher Dr. Iris Gorfinkel in a telephone interview with CTVNews.ca Tuesday.
At the moment, Pfizer is the only COVID-19 vaccine approved for use in Canada for children and teens aged 12 to 18.
Health Canada is currently reviewing Moderna’s application for those aged 12 to 17.
Close to three million U.S. children between 12 and 17 have been vaccinated and clinical studies show the vaccines are safe and effective for that age group, says KidsHealthFirst.ca, an information portal for parents, caregivers, youth and health providers created by the Children’s COVID-19 Vaccine Advisory Table.
The Ontario-based group is made up of more than two dozen infectious disease, pediatric, and public health experts, among others, representing more than half a dozen eminent children’s health organizations including SickKids, the Children’s Hospital of Eastern Ontario, and McMaster Children’s Hospital. The Canadian Paediatric Society also advocates for the COVID-19 vaccination of all children and adolescents aged 12 years and over.
Moderna said in March that its Phase 2 and 3 study would involve 6,750 healthy pediatric participants aged six months to 12 years, and while initial participants were recruited from the U.S., the company said Canadian subjects would be added as time goes on.
Pfizer, which also started its Phase 3 trial in children under 12 in March, follows similar parameters to that of Moderna. Both companies plan to initially test the safety of the two-dose vaccine at three different dosages – 10, 20 and 30 micrograms. All trials in children will evaluate the safety and effectiveness of two doses given 28 days apart and participants will be followed for one year after the second vaccination.
Johnson and Johnson resumed its clinical trials in April after the U.S. Centers for Disease Control (CDC) and the U.S. Food and Drug Administration (FDA) completed a safety review after several cases of blood clots were reported by those who had received the one-dose vaccine. The company said it had started clinical trials for adolescents aged 12 to 17 years of age, but has not released information on when the trial will expand to include children under 12 years of age.
Infectious disease specialist Dr. Isaac Bogoch told CTVNews.ca in a telephone interview Tuesday that the trials are “as simple as looking for safety and efficacy” in children.
“They’re using a lower dose in this age group compared to doses that are used in older age cohorts,” he explained. “Basically they just want to ensure that there’s no adverse effects.”
Bogoch said it was “important to note” that, in general, the age cohort of under 12 years “doesn’t tend to get as sick compared to older age cohorts” and so the bar for vaccines in the trials “should be appropriately set very, very high to ensure that these vaccines really adhere to the highest standards of safety.”
“Vaccination is still important in this age cohort,” he said. “But the threshold we really need to have is clear signal of obvious safety benefit over minimal, if any, risk at all.”