Canada has approved the Pfizer-BioNTech COVID-19 vaccine for children 12 to 15 years old.
The vaccine was initially approved for use in those aged 16 and older in December, and Health Canada received an application from Pfizer to expand the age threshold on April 16 of this year.
“After completing a thorough and independent scientific review of the evidence, the department determined that this vaccine is safe and effective when used in this younger age group,” Health Canada’s chief medical adviser Dr. Supriya Sharma said on Wednesday.
A trial of more than 2,200 youth in that age group in the United States recorded no cases of COVID-19 among vaccinated kids. The trial used the same size doses, and the same two-doses requirement, as the vaccine for adults.
Sharma said the efficacy of the Pfizer vaccine for that age group was 100 per cent after the second dose.
“This is the first vaccine authorized in Canada for the prevention of COVID-19 in children and marks a significant milestone in Canada’s fight against the pandemic,” she said.
Sharma said about one-fifth of all cases of COVID-19 in Canada have occurred in children and teenagers, and having a vaccine for them is a critical part of Canada’s plan.
“While younger people are less likely to experience serious cases of COVID-19, having access to a safe and effective vaccine will help control the disease’s spread to their family and friends, some of whom may be at higher risk of complications,” she said.
Pfizer CEO Albert Bourla said Wednesday the company expects to have data on trials in kids between two and 11 years old in time to apply for authorization in the United States in September.