Health officials in Canada have approved the use of Pfizer–BioNTech’s COVID-19 vaccine for children ages 5 to 11.
“This is the first COVID-19 vaccine authorized in Canada for use in this age group and marks a major milestone in Canada’s fight against COVID-19,” Health Canada said in a statement Friday.
The health agency said it received an application from Pfizer and BioNTech asking to expand the use of Comirnaty, the official name of the drugmakers’ COVID-19 vaccine, on Oct. 18. The vaccine was authorized for use in people 16 years and older on Dec. 9, 2020 and for children from 12 to 15 years old on May 5.
Health Canada said it decided the benefits of the vaccine for younger children outweigh the risks. The department has authorized a two-shot regiment of 10 micrograms to be given three weeks apart. The dosage for children 5 to 11 years old is one-third the size of the dosage approved for people 12 years of age and older.
Data from a clinical trial showed the vaccine was 90.7% effective at preventing COVID-19 in 5- to 11-year-olds with no serious side effects identified, according to Health Canada.
The agency said it is requiring Pfizer and BioNTech to continually provide data about the safety and effectiveness of the vaccine among these younger children. Health Canada added it also will monitor safety data of the vaccine and take necessary action if any safety issues arise.
Just over 75% of Canada’s population are fully vaccinated against COVID-19 as of Friday, health data shows. Meanwhile, more than 85% of the country’s residents aged 12 and up are fully inoculated.
Canada’s approval of the vaccine comes about two weeks after U.S. health officials green-lighted Pfizer’s COVID-19 shots for children ages 5 to 11.
Health, The New York Today