When will children under 12 be vaccinated against COVID-19?
TORONTO -- 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 Canadas National Advisory Committee on Immunization, has echoed that estimate, saying that a vaccine for younger kids isnt 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 Modernas 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 Childrens 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 childrens health organizations including SickKids, the Childrens Hospital of Eastern Ontario, and McMaster Childrens 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.  SAFEST TO KEEP PHYSICALLY DISTANCING  PHAC pointed CTVNews.ca to its public health page of resources for parents when asked about guidance for families thinking of going on vacation now that travel restrictions have eased  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. Gathering limits and restrictions vary across the country, follow your local public health authoritys advice about in-person visits and specific requirements for your community, 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. There's two reasons - number one is individual risk, and number two is population risk, he said. From 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.  Gorfinkel agrees. When 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, she said. But if they could, I imagine they would be saying things like I don't want to go home and infect my diabetic father, and I don't want to go home and learn that I was the person who brought my grandmother illness that led to her hospitalization.  Let's get realistic about this, Gorfinkel said. When 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.  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. You 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, he said. You really have to vaccinate as many people as possible, especially with a more transmissible variant like the Delta variant.  Gorfinkel echoed Bogochs views. The problem with not vaccinating kids is that we cannot move to herd immunity as a society without them - consider the statistics, she said. Kids under the age of 14 make up 16 per cent of the population.  PHAC reiterated that its always safest to keep physically distancing, and suggested that parents of children not eligible to be vaccinated can stay connected with family, friends and neighbours through digital means like texts, email, phone calls and social media platforms. At this time the CDC has not issued guidance on COVID-19 vaccines for children under 12, as none have been approved for use in that age group yet. The World Health Organization says in its guidance that it is holding off on making general recommendations on vaccinating children against COVID-19 until more evidence is available. WHO'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, the WHO site reads. Vaccine trials for children are ongoing and WHO will update its recommendations when the evidence or epidemiological situation warrants a change in policy.  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. They should - they are obviously looking out for their children as it should be, he said. They probably will have a ton of questions and that's completely appropriate. We can't just blindly walk into major health decisions.  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. At the end of the day, ask yourself a general question - will there be a COVID-19 vaccine for kids? he said. The answer is yes, there sure will be, it's just a matter of when.  -----  With files from CTVNews.cas Solarina Ho