Pfizer’s COVID vaccine approved for kids under 5 in Canada

A second COVID-19 vaccine for Canadian children under the age of five years has been approved.

On Friday, Health Canada authorized Pfizer‘s pediatric COVID-19 shot for children aged six months to four years.

In approving the Pfizer-BioNTech Comirnaty COVID-19 vaccine for children under five, Health Canada said the benefits of this vaccine outweigh the potential risks in the age group.

Three doses of Pfizer’s pediatric vaccine, of three micrograms each, have been authorized for children under five, Health Canada said in a statement.

The first and second doses should be spaced out by three weeks, with a booster dose given eight weeks later.

Health Canada made the decision after reviewing data from a Phase 2/3 randomized, controlled trial that included 4,526 children aged six months to four years old.

“The safety profile in children six months to four years of age was comparable to that observed in children five to 12 years old,” it said.

The National Advisory Committee on Immunization (NACI) will issue recommendations on the use of Pfizer’s vaccine for the under-five group, the agency added.

Pfizer said it will begin shipping its three-microgram pediatric doses as directed by the Canadian government and public health agencies across the country, but did not give a timeline.

“We know many parents in Canada have at heart to provide further protection for their children under five,” Fabien Paquette of Pfizer Canada said in a statement Friday.

“With this Health Canada authorization, we have achieved another key milestone in our ongoing effort to help protect families and communities against COVID-19.”

The latest vaccine approval comes ahead of the fall season, when experts in Canada are anticipating another COVID-19 wave as children return to in-person classes and people gather indoors.

Last month, the first COVID-19 booster vaccine for children aged five to 11 years was approved in Canada.

In July, Health Canada approved Moderna’s Spikevax COVID-19 shot for the nearly two million children under the age of five.

by Global News