A significant move from Health Canada as they approve the Pfizer COVID-19 vaccine for children between the ages of 5 and 11.
This is the first COVID-19 vaccine authorized in Canada for use in this age group and marks a major milestone in Canada’s vaccine efforts.
The vaccine originally was submitted for approval for the age group on Oct. 18.
A statement regarding the approval was released Friday morning:
“After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks. Health Canada has authorized a two-dose regimen of 10 micrograms to be administered three weeks apart, which is a lower dose than the 30 micrograms two-dose regimen authorized for people 12 years of age and older. The clinical trial showed that the immune response in children 5 to 11 years of age was comparable to the immune response in people 16 to 25 years of age. The vaccine was 90.7% effective at preventing COVID-19 in children 5 to 11 years of age and no serious side effects were identified.”
Health Canada is currently still reviewing the Moderna vaccine for children aged 6 to 11.
Currently in Canada 78.8 per cent of people 12 and older have received at least one dose of an approved vaccine, while 75.3 per cent are fully vaccinated.
Canada’s chief public health officer Dr. Theresa Tam says the new lower dose will be 10 micrograms, compared to 30 for adults and teens.
Dr. Tam says data shows that the 10 microgram dose works very well at preventing symptomatic COVID-19 in that age group with an estimated accuracy of 90.7%
She notes the recommended time interval between first and second shot is at least 8 weeks.
Dr. Tam adds, “To date no serious safety concerns have been identified in the clinical trials. Going forward we will be closely monitoring domestic roll-out of the pediatric program in Canada and continuing to review accumulating evidence from International programs and studies.”
Details on the rollout are expected Friday afternoon.