PFE Pfizer Inc

By Kim Mackrael and Jared S. Hopkins 

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.

The Pfizer-BioNTech vaccine is currently authorized for use in the U.S. and Europe for individuals 16 and older.

Pfizer said Tuesday that it plans to ask U.S. regulators to authorize the vaccine for children between 2 and 11 years old in September, should a study under way prove positive.

Children are at lower risk of Covid-19 infection than adults, according to health experts, and when they are infected they tend to experience milder symptoms. Yet some can become seriously ill and some can spread the virus.

The vaccine's expanded use is expected to boost Canada and the world's vaccination campaign seeking to immunize as many people as possible before dangerous variants able to elude shots emerge.

Canada has experienced a damaging third wave of infections in recent months after a slow start to its vaccination campaign, prompting some jurisdictions to close schools, restaurants and nonessential stores. Canada's per capita rate of reported Covid-19 cases surpassed that of the U.S. for the first time last month, but cases in Canada have leveled off in recent weeks.

Roughly 35% of Canadians had received at least one vaccine dose as of Tuesday, according to data compiled by the University of Oxford's Our World in Data project. In the U.S., about 44% of the population had received at least one dose by that day.

"It's definitely a step in the right direction," Christina Guzzo, a professor of virology at the University of Toronto Scarborough, said of Health Canada's announcement. "The more healthy individuals that we can vaccinate, that's obviously one step closer to the end game in the pandemic."

Pfizer shares were up 2.4% in U.S. trading early Wednesday afternoon, while BioNTech's shares were up more than 6%.

"Today's expansion of our authorization represents a significant step forward in helping the Canadian government broaden its vaccination program and begin to help protect adolescents before the start of the next school year," said Fabien Paquette, head of vaccines for Pfizer's Canadian subsidiary.

Write to Kim Mackrael at kim.mackrael@wsj.com and Jared S. Hopkins at jared.hopkins@wsj.com

(END) Dow Jones Newswires

May 05, 2021 13:38 ET (17:38 GMT)

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