Pfizer intends to submit data to Health Canada on trials of its COVID-19 vaccine in children under 12 by the end of the year, the company told Global News.
In a statement, Pfizer said that it had completed its Phase 1 trial of the vaccine in children, which was designed to determine the optimal dose for kids of different age groups.
Phase 2 and 3 trials are ongoing, the company said, “to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 5-11, and in children 6 months-5 years.”
“If safety and immunogenicity are confirmed, we plan on filing the data to Health Canada before the end of the year to support a potential authorization in children 5 to 11 years of age, and soon after for 6 months to 5 years,” wrote the company.
This data needs to be reviewed by Health Canada to determine whether the government will authorize the use of the Pfizer-BioNTech vaccine in children under 12. Health Canada approved the use of the vaccine in children aged 12-16 in May 2021.
Moderna, which makes a COVID-19 vaccine approved for use in people older than 16, said only that its study of the vaccine in the pediatric population is “ongoing” and would not provide details on a timeline.
AstraZeneca said that its partner Oxford University was currently conducting trials on the pediatric population for its vaccine.
“The trial continues with no safety concerns and details of immune responses will be provided when available,” the company said in a statement.
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