Children cool off in a fountain as hot and humid weather continues in Toronto, Canada, on July 1, 2021. (Photo by Zou Zheng/Xinhua)
This is the first COVID-19 vaccine authorized in Canada for use in this age group with approximately 1.7 million children, Health Canada said.
OTTAWA, July 14 (Xinhua) -- Canada's drug regulator announced Thursday it has authorized the use of the Moderna Spikevax COVID-19 vaccine in children six months to five years of age.
This is the first COVID-19 vaccine authorized in Canada for use in this age group with approximately 1.7 million children, Health Canada said in a statement.
Health Canada, which received an application from Moderna to expand the indication of Spikevax on April 29, 2022, initially authorized the vaccine for use in people 18 years of age and older in December 2020, and subsequently authorized for children 12 to 17 years of age in August 2021, and children 6 to 11 years of age in March 2022.
According to the statement, Health Canada has authorized a two-dose primary series of 25 micrograms each, with the second dose to be administered 4 weeks after the first dose. This is half the dose authorized for children six to 11 years of age and one quarter of the dose authorized for people over 12 years of age.
The clinical trial showed that the immune response to Spikevax in children six months to five years of age was comparable to that seen in people 18 to 25 years of age from a previous study. Efficacy was assessed when Omicron was the predominant variant of COVID-19 and the vaccine was well tolerated without safety signals from the trial, Health Canada said.
Pfizer's COVID-19 vaccine for children six months to five years of age has been submitted to Health Canada and is still under review. ■