Health Canada authorizes Pfizer-BioNTech COVID-19 vaccine for children six months to four years of age

OTTAWA, ON, Sept. 9, 2022 /CNW/ - Today, Health Canada authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine in children six months to four years of age. This is the second COVID-19 vaccine authorized in Canada for this age group.

After a thorough and independent scientific review of the evidence, Health Canada has determined that the benefits of this vaccine outweigh the potential risks in this age group. Vaccination continues to be one of the most effective ways to protect ourselves, our families and our communities against COVID-19. Evidence continues to indicate that the vaccines used in Canada are very effective at preventing severe illness, hospitalization and death from COVID-19. 

Health Canada has authorized a three-dose primary series of three micrograms each, with three weeks between the first and second doses and eight weeks between the second and third doses. For comparison, the primary series for children 5 to 11 years of age is two doses, 10 micrograms each, and for people 12 years of age and older it's two doses, 30 micrograms each.

Health Canada has placed terms and conditions on the authorization 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 determine whether this vaccine remains a safe and effective way for children to be protected against COVID-19.

Health Canada received an application from Pfizer-BioNTech to expand the indication of Comirnaty to this age group on June 23, 2022. Health Canada initially authorized the vaccine for use in people 16 years of age and older on December 9, 2020; for adolescents 12 to 15 years of age on May 5, 2021; and for children 5 to 11 years of age on November 19, 2021.

In keeping with Health Canada's commitment to openness and transparency, the Department is publishing multiple documents related to this decision, including a high-level summary of the evidence it reviewed.

The National Advisory Committee on Immunization's recommendations on the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine in this age group are expected to be published by the Public Health Agency of Canada in the short term.

Health Canada and the Public Health Agency of Canada will continue to closely monitor the safety of this vaccine in Canada and internationally, and will take action if any safety concerns are identified.

Related Links:

Pfizer vaccine product page 
Vaccines for children: COVID-19  
COVID-19 vaccines and treatments portal

SOURCE Health Canada

Media Relations: Health Canada, 613-957-2983, [email protected]; COVID-19 public enquiries: 1-833-784-4397