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 鈥 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 鈥渁ll manufacturers of the COVID-19 vaccines authorized in Canada are conducting or planning studies in adolescents and younger children,鈥 and that the organization expected data 鈥渋n the coming months.鈥
鈥淎t this time, no submission has been received for the approval of any COVID-19 vaccine in children under 12 years of age,鈥 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鈥檚 National Advisory Committee on Immunization, has echoed that estimate, saying that a vaccine for younger kids isn鈥檛 expected until 2022 but some health experts hope that timeline will be moved up.
鈥淲hen 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,鈥 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鈥檚 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 , an information portal for parents, caregivers, youth and health providers created by the Children鈥檚 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鈥檚 health organizations including SickKids, the Children鈥檚 Hospital of Eastern Ontario, and McMaster Children鈥檚 Hospital. The 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 鈥 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 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 鈥渁s simple as looking for safety and efficacy鈥 in children.
鈥淭hey're using a lower dose in this age group compared to doses that are used in older age cohorts,鈥 he explained. 鈥淏asically they just want to ensure that there's no adverse effects.鈥
Bogoch said it was 鈥渋mportant to note鈥 that, in general, the age cohort of under 12 years 鈥渄oesn't tend to get as sick compared to older age cohorts鈥 and so the bar for vaccines in the trials 鈥渟hould be appropriately set very, very high to ensure that these vaccines really adhere to the highest standards of safety.鈥
鈥淰accination is still important in this age cohort,鈥 he said. 鈥淏ut the threshold we really need to have is clear signal of obvious safety benefit over minimal, if any, risk at all.鈥
PHAC pointed CTVNews.ca to its for parents when asked about guidance for families thinking of going on vacation now that travel restrictions have eased 鈥 but some unvaccinated children still face isolating upon their return to Canada.
The agency said that parents should contact their local public health authorities for guidance on which protocols unvaccinated children should follow at this time.
鈥淕athering limits and restrictions vary across the country, follow your local public health authority鈥檚 advice about in-person visits and specific requirements for your community,鈥 the statement reads.
Bogoch said parents need to weigh several things when determining whether to vaccinate their children against COVID-19, even though children under 12 are not considered particularly high risk.
鈥淭here's two reasons - number one is individual risk, and number two is population risk,鈥 he said. 鈥淔rom an individual risk standpoint, even though the risk is low, that doesn't mean the risk is zero. We do know that there are kids that sadly get sick enough to land in hospital and often, sadly, succumb to the illness. And if you have a safe and effective vaccine that can prevent that, it's a no brainer we should be using it.鈥
Gorfinkel agrees.
鈥淲hen it comes to our duty toward children, they are in a way that person who has no voice, they're not able to say what their needs are, 鈥渟he said. 鈥淏ut if they could, I imagine they would be saying things like 鈥業 don't want to go home and infect my diabetic father,鈥 and 鈥業 don't want to go home and learn that I was the person who brought my grandmother illness that led to her hospitalization.鈥欌
鈥淟et's get realistic about this,鈥 Gorfinkel said. 鈥淲hen we talk about kids and what benefits them are healthy family members, what benefits them is not learning that they inadvertently took a disease home from school and infected someone.鈥
Bogoch also said consideration needs to be given to children who have underlying risk factors that make them at higher risk of severe illness.
And when it comes to public health, Bogoch said the under-12s represent an important factor in trying to achieve community level protection.
鈥淵ou know, you can't just draw an artificial line in the sand and ignore the millions of people who are under the age of 12 who can still get this infection and can still transmit this infection,鈥 he said. 鈥淵ou really have to vaccinate as many people as possible, especially with a more transmissible variant like the Delta variant.鈥
Gorfinkel echoed Bogoch鈥檚 views.
鈥淭he problem with not vaccinating kids is that we cannot move to herd immunity as a society without them - consider the statistics,鈥 she said. 鈥淜ids under the age of 14 make up 16 per cent of the population.鈥
PHAC reiterated that 鈥渋t鈥檚 always safest to keep physically distancing,鈥 and suggested that parents of children not eligible to be vaccinated can 鈥渟tay connected鈥 with family, friends and neighbours through digital means like texts, email, phone calls and social media platforms.
At this time the CDC , as none have been approved for use in that age group yet.
The World Health Organization that it is holding off on making general recommendations on vaccinating children against COVID-19 until more evidence is available.
鈥淲HO's Strategic Advisory Group of Experts (SAGE) has concluded that the Pfizer/BionTech vaccine is suitable for use by people aged 12 years and above. Children aged between 12 and 15 who are at high risk may be offered this vaccine alongside other priority groups for vaccination,鈥 the WHO site reads.
鈥淰accine trials for children are ongoing and WHO will update its recommendations when the evidence or epidemiological situation warrants a change in policy.鈥
For parents who may be struggling with whether or not they want to have their children vaccinated against COVID-19, Bogoch was encouraged that many people have questions.
鈥淭hey should - they are obviously looking out for their children as it should be,鈥 he said. 鈥淭hey probably will have a ton of questions and that's completely appropriate. We can't just blindly walk into major health decisions.鈥
Bogoch said parents should be reaching out to their pediatricians and family doctors to discuss the decision in detail, and said Canadians will have to be patient.
鈥淎t the end of the day, ask yourself a general question - will there be a COVID-19 vaccine for kids?鈥 he said. 鈥淭he answer is yes, there sure will be, it's just a matter of when.鈥
-----
With files from CTVNews.ca鈥檚 Solarina Ho
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