Canada Authorizes Pfizer-BioNTech Covid-19 Vaccine for Children 12 to 15 Years Old

OTTAWA—Canada authorized the use of the Pfizer-BioNTech Covid-19 vaccine for adolescents, moving ahead of the U.S. Food and Drug Administration and making it the first Western economy to permit the vaccine’s use in individuals under 16 years of age.

Health Canada said its authorization means children between the ages of 12 and 15 will be able to receive the Pfizer-BioNTech vaccine. It didn’t provide a timeline for when the two-dose shot would become available to that age group.

The Covid-19 vaccine developed by Pfizer Inc. and BioNTech SE was found to be 100% effective in protecting against symptomatic disease in a study of more than 2,200 children, the companies said in late March. Researchers didn’t find any safety concerns.

Canadian officials said they reviewed the study’s results in making their decision. “After completing a thorough and independent scientific review of the evidence, the department determined the vaccine is safe and effective when used in this younger age group,” said Dr. Supriya Sharma, senior medical adviser at Health Canada.

The FDA is considering a request for authorization of the Pfizer-BioNTech vaccine for adolescents, which could make the vaccine available to children in the coming weeks. Regulators in Europe are also reviewing a request to authorize the vaccine for children.