Canadian health regulators stated that they were the first to approve Pfizer’s COVID-19 vaccine for use in children under 12 years of age.
Wednesday, 3:35 p.m. – Canadian health officials in Toronto announced that they had finalized the first approval for Pfizer’s COVID-19 vaccine for children under 12 years of age, stating that this would help children return to normal life. Canada is the first country to authorize Pfizer’s vaccine for this age group. The United States and the European Union are also reviewing it.
The vaccine was previously authorized for individuals aged 16 years or older.
The U.S. Food and Drug Administration (FDA) is also expected to approve Pfizer’s vaccine for younger individuals next week, enabling vaccinations for many before the start of the next academic year. This announcement comes just one month after Pfizer discovered that its vaccine also provides protection for younger age groups. In late March, Pfizer released preliminary results from a vaccine study involving participants aged 16 and older. Among 260 U.S. volunteers aged 12 to 15, no cases of COVID-19 were observed in adolescents who received the full vaccine regimen, whereas 18 cases occurred among those who received the placebo.
Sharma stated that there is evidence demonstrating the vaccine’s safety and efficacy in this age group. This marks the first vaccine approved for use in children in Canada.
Approximately one in five COVID-19 cases in Canada occurs among children and adolescents, making their vaccination a key component of Canada’s strategy.
She said that although most children do not develop severe illness from COVID-19, vaccines also help protect their friends and family members, who may be at higher risk for complications. Vaccines will also help our children return to a more normal life after the difficult times they have endured over the past year.
The company stated that children in the study experienced side effects similar to those in younger individuals, primarily pain, fever, chills, and fatigue, particularly after the second dose. The study will continue to follow participants for two years to gather more information on long-term protection and safety. “Today, our authorization has been expanded, which is an important step in helping the Canadian government broaden its vaccination program and begin protecting adolescents before the next school year begins,” said Fabien Paquette, Head of Vaccines at Pfizer Canada, in a statement.
Health Canada stated that it would require Pfizer Inc. to continue providing information on vaccine safety.
In recent months, Canada’s vaccine administration has been steadily increasing, with the government expecting to receive at least 10 million doses this month. More than 34% of Canadians have received at least one dose. Commenting on the new approval, Dr. Andrew Morris, Professor of Infectious Diseases at the University of Toronto and Medical Director of the Antimicrobial Stewardship Program at the Sinai Health System, stated, “We need to vaccinate as many people as possible as quickly as possible.”