Health Canada announced this morning (Nov. 19) it has authorized a COVID-19 vaccine for use in children between 5 and 11 years old.
Pfizer-BioNTech submitted an application for a children's vaccine to Health Canada on Oct. 18. It was previously approved by the FDA for use in children in the United States on Oct. 29.
The Pfizer-BioNTech will be the first COVID-19 vaccine authorized in Canada for use in children under 12 years old.
"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," states a news release from Health Canada.
The two-dose schedule approved for children is 10 micrograms administered three weeks apart, which is lower than the two doses at 30 micrograms given to people aged 12 years and older.
According to Health Canada, clinical trials indicated the vaccine was 90.7 per cent effective at preventing COVID-19 in children 5-11 years old with no serious side effects identified.
There are terms and conditions requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety and efficacy of the vaccine in children.
The agency will continue to monitor the vaccine's effects on children.
Health Canada has also published a high-level summary of the evidence it received to inform its decision. You can read the summary on the Health Canada website here.
