On November 19, 2021, Health Canada took an important step in the fight against COVID-19 by approving Pfizer-BioNTech’s Comirnaty vaccine for use in children aged five to 11.
Health Canada received a submission, on October 18, 2021, from Pfizer-BioNTech seeking authorization for the use of its Comirnaty COVID-19 vaccine in children aged five to 11. The regulator reviewed the efficacy and safety data, as well as the benefits and risks of the vaccine, and concluded that it meets the highest standards and is safe and effective. As a result, Health Canada authorized a two-dose regimen of 10 micrograms to be administered three weeks apart. These doses generated an immune response comparable to that triggered by the 30-microgram, two-dose regimen authorized for people 12 years of age and older.
The fact that this segment of the Canadian population can now be vaccinated is a major milestone in the fight against COVID-19 seeing as it will help flatten the curve in our communities. In recent weeks, children under the age of 12 account for the highest number of new COVID-19 infections across the country. This expansion of Canada’s vaccination campaign to children will help slow the spread of the disease to society’s most vulnerable groups and to unvaccinated individuals. To date, 79.02% of Canadians have received at least one dose of the vaccine. A vaccination campaign aimed at immunizing children will allow us to achieve a higher level of immunity and to manage the pandemic more effectively.
More importantly, young children will finally be protected from COVID-19. According to data submitted to Health Canada, Pfizer’s clinical trials — which included more than 4,600 participants (3,100 vaccine, 1,538 placebo) of ages five through 11 — found the vaccine to be 90.7% effective in preventing COVID-19 in children of this age group. In addition, no serious side effects were detected.
Incidentally, no cases of myocarditis (inflammation of the heart muscle) were reported during the Comirnaty vaccine clinical trials. For parents who are concerned that incidences of myocarditis will occur in children once the vaccine is used on a larger scale across the country, there are many aspects to consider. In older age groups, the risk of developing myocarditis after being infected with COVID-19 is much higher than that of developing it after receiving a COVID-19 mRNA vaccine. In addition, most of the myocarditis cases detected in recent months have been mild, and patients have recovered quickly.
Although children have a lower risk of becoming severely ill from COVID-19, it is wrong to assume that they are immune from harm or less affected by the disease. Hospitalizations in children are on the rise, with reports from the United States indicating that nearly one third of the children who have been hospitalized were otherwise healthy. Children are also at risk of developing long-haul COVID symptoms after being infected.
Younger children are also more likely to develop multisystemic inflammatory syndrome (MIS-C). MIS-C is one of the more severe illnesses that can occur after COVID-19 infection, observed since the start of the pandemic. Although cases of MIS-C are rare, most of them have been reported in otherwise healthy children. Children with MIS-C are more likely to develop severe symptoms and be admitted to intensive care units, and deaths have been reported.
Vaccination provides an additional layer of protection for our young children who are experiencing the disastrous consequences of COVID-19 firsthand. Schools are still experiencing active outbreaks, which inevitably lead to class closures and may have a negative impact on children’s mental health. Although measures are being systematically enforced to stop the spread of COVID-19 in classrooms, some parents have had to face the fact that their children will have no immune protection should they be exposed to the virus.
Health Canada’s announcement reassures parents that they will finally have a safe and effective way to protect their children and will gradually return to normality. Health Canada will continue to monitor the safety and efficacy of the Comirnaty vaccine for children five to 11 years of age, and Pfizer-BioNtech will be required to continue providing data on real-world use of the vaccine.
One thing is certain: vaccines for children aged five to 11 years old will finally give them the freedom to thrive, enjoy a safe childhood and just be kids again.
Senators Marie-Françoise Mégie, Rosemary Moodie, Mohamed-Iqbal Ravalia and Stan Kutcher have all worked as medical doctors. They represent, respectively, the division of Rougemont in Quebec, Ontario, Newfoundland and Labrador, and Nova Scotia in the Senate.