Health Canada authorizes use of Pfizer COVID-19 vaccine in children under 12 years of age

Clinical trials identified no serious side effects

Health Canada has given the green light to use the COVID-19 Pfizer vaccine to immunize children 5 to 11 years of age.

This is the first COVID vaccine authorized in Canada for use in kids under the age of 12.

The vaccine was initially authorized for use in people 16 years of age and older in December 2020, and then for children 12 to 15 years of age in May of this year.

The jab children under 11 will receive is a lower dose than what people 12 and older are getting.

The federal Immunization Advisory Panel is recommending at least eight weeks between dose one and dose two. This is to bring about the strongest immune response possible while lowering any risk of heart inflammation.

Clinical trials by Health Canada showed 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, and the vaccine was 90.7% effective at preventing COVID-19 in that younger age bracket. As well, no serious side effects were identified.

Health Canada has placed terms and conditions requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety and efficacy of the vaccine in this younger age group. This will provide the Department with more data from ongoing studies and real-world use to ensure that the benefits of the vaccine continue to outweigh any risks, as well as to detect any potential new safety signals in any age group.

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 government says a shipment of 2.9 million child-sized doses of the vaccine, enough for a first dose for every child in the five to 11 age group will arrive at the end of next week.

The U.S. Food and Drug Administration approved the Pfizer-BioNTech vaccine for children on October 29, and the United States has already vaccinated more than two million children.