Health Canada approves first COVID-19 vaccine for kids 5 to 11
OTTAWA — Health Canada has approved the first COVID-19 vaccine for children aged five to 11 in Canada.
Pfizer and its partner BioNTech submitted a request for approval of a child-sized dose of its mRNA vaccine for COVID-19 on Oct. 18.
The companies say the results of their trials in children show comparable safety and efficacy to those recorded in a previous Pfizer-BioNTech study in people aged 16 to 25.
After a thorough review of the data, the department has determined the benefits of the vaccine for children between five and 11 years of age outweigh the risks, Health Canada said in a statement Friday.
“Overall this is very good news for adults and children alike,” said Dr. Supriya Sharma, Health Canada’s chief medical adviser, in reference to the growing number of COVID-19 cases among children during the fourth wave of the pandemic.
The vaccine was 90.7% effective at preventing COVID-19 in children and no serious side-effects were identified, according to the regulator.
The National Advisory Committee on Immunization has suggested that two doses may be offered to children between five and 11 years of age, with at least eight weeks between doses.
“It is very important that we support children and their caregivers, and making informed decisions about COVID 19 vaccination, while respecting their choices and pace of decision-making,” said chief public health officer Dr. Theresa Tam.
Pfizer-BioNTech has changed the formulation of the pediatric vaccine slightly, so new vaccines must be delivered to Canada before children can receive a shot.
Canada is expecting an accelerated delivery of 2.9 million child-sized doses, enough for a first dose for every child in the five to 11 age group.
In a statement Friday, Pfizer said the doses would be shipped “imminently.”
Provinces are poised and ready to start administrating doses as soon as they have them in hand.
Main side-effects for children associated with the vaccine are the same as those for slightly older vaccine recipients, though they were less common in kids, aside from redness and swelling at the injection site.
Health Canada will require Pfizer-BioNTech to continue to report on ongoing studies and real-world use to monitor any issues related to the vaccine in children.
“Health Canada and the Public Health Agency of Canada will continue to closely monitor the safety of this vaccine, and will take action if any safety concerns are identified,” the statement read.