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Added: October 2, 2021
Pfizer and its partner BioNTech have submitted preliminary data from their trial for a COVID-19 shot for kids to Health Canada earlier than expected, the department confirmed Saturday.
A formal filing of the submission for authorization of a vaccine for children is expected in mid-October, according to an email from Health Canada.
Authorization of a vaccine for children between the ages of five and 11 years old would be a major step. There are currently no COVID-19 vaccines authorized for children under 12 years old in Canada.
Earlier in the week, Pfizer submitted data on its study for a vaccine for children to the U.S. Food and Drug Administration, with a formal request for emergency use authorization there also expected in the coming weeks.
The Pfizer vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up in the U.S., has been shown to induce a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.
For children between the ages of five and 11 in the trial, the company used doses that are one-third the amount given to adults now.
Canada’s chief public health officer, Dr. Theresa Tam, told reporters last week that safety was the top priority when it came to vaccinations in children.
“For the 12 to 17 year olds, so far those programs are going well. There’s no specific safety concern. I do think seeing the safety data in the younger children is of paramount importance,” she said.
Timeline unclear for now
Scott Gottlieb, a former FDA commissioner and current Pfizer board member, told CBC’s Power & Politics that the company could be approved for emergency use authorization in the U.S. by Halloween.
The approval of the Pfizer vaccine for adults took about two months from its first data submissions to Health Canada.
Canada may need to procure a separate supply of doses for children, if authorization is granted by Health Canada.
“I don’t suspect it’s as easy as taking what we’ve already got in the warehouse,” said a federal official speaking to CBC News on background. “That will come from their submission to the regulator.”
The federal government signed a deal in April to get more shots from Pfizer — including, if necessary, the pediatric variety and reformulated booster shots for adults — but deliveries of this new batch aren’t expected to start until sometime in the new year.
Over 76 per cent of all Canadians have received at least one dose of a COVID-19 vaccine, while almost 71 per cent are fully vaccinated with two doses, according to CBC’s vaccination tracker.