Pfizer submits preliminary data to Health Canada for kids' COVID-19 vaccine trial
CBC
Pfizer and its partner BioNTech have submitted preliminary data from their trial for a COVID-19 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.