Today, Health Canada has authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine in children 5 to 11 years of age.
This is the first COVID-19 vaccine authorized in Canada for use in this age group and marks a major milestone in Canada’s fight against COVID-19.
Health Canada received an application from Pfizer-BioNTech to expand the indication of Comirnaty just over a month ago, on October 18, 2021.
It says 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.
In keeping with the Department’s commitment to openness and transparency, Health Canada is publishing multiple documents related to this decision, including a high-level summary of the evidence it reviewed.
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.
For more details on the vaccine and its ingredients, please click here.
Health Canada has authorized the use of the Pfizer-BioNTech vaccine for children aged 5–11, confirms Dr. Supriya Sharma, chief medical adviser with Health Canada.
Pfizer is the first COVID-19 vaccine to be authorized for use with this age group in Canada.#cdnpoli | #COVID19 pic.twitter.com/9e9WzF1kqT
— CPAC (@CPAC_TV) November 19, 2021
⬇️🖥️LIVE: Federal health officials provide update on Pfizer-BioNTech COVID-19 vaccines
⬇️🖥️EN DIRECT : Les autorités sanitaires fédérales font le point sur les vaccins de Pfizer-BioNTech contre la COVID-19#cdnpoli | #polcan | #COVID19 https://t.co/sFHme5dF5l
— CPAC (@CPAC_TV) November 19, 2021
(1/9) The NACI recommends two 10 mcg doses of the Pfizer-BioNTech Comirnaty #CovidVaccine may be offered to children 5-11 years of age, with at least 8 weeks between the first and second dose. Read the summary of NACI’s recommendations: https://t.co/W9RHyOe4RJ pic.twitter.com/y50P5qtLb7
— Health Canada and PHAC (@GovCanHealth) November 19, 2021