Canada authorizes Pfizer BioNTech COVID 19 vaccine for children 5 to 11 years of age
Christian Fernsby ▼ | November 19, 2021
Health Canada authorized the use of the Pfizer BioNTech Comirnaty COVID 19 vaccine in children 5 to 11 years of age.Article continues below
This is the first COVID 19 vaccine authorized in Canada for use in this age group. Health Canada received an application from Pfizer BioNTech to expand the indication of Comirnaty on October 18, 2021.
The vaccine was initially authorized for use in people 16 years of age and older on December 9, 2020, and subsequently authorized for children 12 to 15 years of age on May 5, 2021.
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.
Health Canada has placed terms and conditions 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 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. ■ What to read next
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