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.
The vaccine was 90.7 per cent 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.
For now NACI suggests children wait at least 14 days before or after receiving another vaccine, such as the flu shot, to get the COVID-19 vaccine.
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.
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 Thursday, Pfizer Canada said the company is prepared to deliver the pediatric doses to Canada shortly following federal authorization.
Meanwhile provinces are poised and ready to start administrating doses as soon as they have them in hand.
The U.S. Food and Drug Administration approved the Pfizer-BioNTech vaccine for children on Oct. 29, and the United States has already vaccinated more than two million children.
The Canadian government is also expected to announce Friday an easing of measures taken to prevent importing new cases across the border.
Federal ministers are set to discuss the changes at 1 p.m.
They are expected to do away with the rule that requires travellers taking short trips to the U.S. to present a negative molecular COVID-19 test in order to get back into the country.
This report by The Canadian Press was first published Nov. 19, 2021.
Laura Osman, The Canadian Press