Health Canada authorized the use of the Moderna Spikevax (50 mcg) COVID-19 vaccine in children 6 to 11 years of age. This is the second COVID-19 vaccine authorized in Canada for use in this younger age group.
Health Canada received an application from Moderna to expand the indication of its Spikevax vaccine on November 16, 2021. The vaccine was initially authorized for use in people 18 years of age and older on December 23, 2020, and subsequently authorized for children 12 to 17 years of age on August 27, 2021.
After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 6 and 11 years of age outweigh the risks. Health Canada has authorized a primary two-dose regimen of 50 micrograms per dose to be administered four weeks apart. This is half of the 100 micrograms primary two-dose regimen authorized for people 12 years of age and older.
The clinical trial showed that the immune response in children 6 to 11 years of age was comparable to the immune response in people 18 to 25 years of age, supporting the vaccine efficacy in this younger age group. No serious adverse events were observed during the trial.
Health Canada has placed terms and conditions requiring Moderna to continue providing information to Health Canada on the safety and efficacy of the vaccine in this younger age group, including information on protection against current and emerging variants of concern. 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.
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.