Recommendation on the use of the Pfizer-BioNTech COVID-19 vaccine (10 mcg) in children 5-11 years of age

The Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine is the first COVID-19 vaccine authorized in Canada for use in pediatric populations under the age of 12 years. Pfizer-BioNTech [10 microgram (mcg) dose] was approved for children 5-11 years of age on November 19, 2021. The Pfizer-BioNTech (Comirnaty) COVID-19 vaccine has been previously authorized by Health Canada as follows: 

• December 9, 2020 for individuals 16 years of age and over under an Interim Order using a 30 mcg dose
• May 18, 2021 for individuals 12 to 15 years of age under an Interim Order using a 30 mcg dose
• September 16, 2021 for individuals 12 years of age and over as a full authorization under the name Comirnaty using a 30 mcg dose

On May 18, 2021, following Health Canada authorization of the Pfizer-BioNTech vaccine (30 mcg dose) for individuals 12 to 15 years of age under the Interim Order, NACI recommended the use of the vaccine in adolescents (Strong NACI Recommendation) based on a review of available evidence including additional clinical trial results in the adolescent population. On August 27, 2021, Health Canada expanded the Interim Order authorization for the Moderna (SpikeVax) COVID-19 vaccine to also include adolescents 12 to 17 years of age. That same day, NACI issued updated guidance on the use of mRNA COVID-19 vaccines in adolescents, incorporating additional evidence including clinical data on the efficacy, safety, and immunogenicity of the Moderna COVID-19 vaccine in adolescents as well as post-market safety and effectiveness reports on both mRNA COVID-19 vaccines. Subsequently, Moderna received full authorization on September 16, 2021 for individuals 12 years of age and over under the name Spikevax.

NACI’s recommendations are aligned with the following goals of the Canadian COVID-19 Immunization Program, updated in October, 2021: i) to enable as many Canadians as possible to be immunized as quickly as possible against COVID-19, while ensuring that high risk populations be prioritized; ii) minimize serious illness and overall deaths while preserving health system capacity; and iii) reduce transmission to protect high risk populations.