Canada approved the use of Pfizer-BioNTech’s coronavirus vaccine for children ages 5 to 11 on Friday, adding more than 2.8 million young people to those eligible for a shot.
“Overall, this is very good news for adults and children alike,” Dr. Supriya Sharma, chief medical adviser at Health Canada, the agency responsible for drug authorization in the country, said at a news conference. “It provides another tool to protect Canadians and, to the relief of many parents, will help bring back a degree of normality to children’s lives, allowing them to more safely do the things that they have missed during the last 20 months.”
Pfizer’s is the first coronavirus vaccine to be approved in Canada for children ages 5 to 11. Health Canada based its approval on a clinical trial comprising 4,600 children, Dr. Sharma said, with 3,100 children receiving two doses of the vaccine spaced three weeks apart and 1,500 receiving a placebo.
There were four adverse reactions unconnected to the vaccinations, and none of the children experienced heart inflammation or severe allergic reactions.
The pediatric doses — each one-third of the adult dose — will be stored in vials with an orange cap, and the cartons’ labels will have orange borders, to differentiate them from the adult vials, Christina Antoniou, a spokeswoman for Pfizer Canada, said in an email.
Nearly 75 percent of all Canadians, or more than 28.5 million people, are fully vaccinated. More than 16,800 coronavirus cases have been reported across the country in the past seven days, according to national public health data, with the highest per capita rates in Yukon and the Northwest Territories.