Kamis, 07 Oktober 2021

Pfizer to seek approval in Canada for COVID-19 vaccine for kids as young as five - The Globe and Mail

People walk by a COVID-19 vaccination sign in Montreal on Aug. 7.

Graham Hughes/The Canadian Press

Pfizer Canada says it is preparing to ask Health Canada to authorize its COVID-19 vaccine for kids as young as five by mid-October.

The U.S. drugmaker submitted a formal request to the U.S. Food and Drug Administration today and the FDA intends to meet to discuss the submission on Oct. 26.

Last week Pfizer submitted data to both governments from a clinical trial on children five to 11 but hadn’t formally requested authorization.

A spokeswoman for the company’s Canadian arm says it is in the final stages of working with Health Canada ahead of the submission being made so kids between five and 11 can be given the shots here.

The vaccine was authorized for people at least 16 years old in December 2020 and for teenagers between 12 and 15 in May.

The dose for younger children is one-third the size given to adults and Pfizer and Health Canada have not yet said if vaccine supplies already in Canadian freezers can be adapted for use on children or if new shipments must be made.

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https://news.google.com/__i/rss/rd/articles/CBMidWh0dHBzOi8vd3d3LnRoZWdsb2JlYW5kbWFpbC5jb20vd29ybGQvYXJ0aWNsZS1wZml6ZXItYmlvbnRlY2gtYXNrLXVzLXJlZ3VsYXRvcnMtdG8tYXBwcm92ZS1jb3ZpZC0xOS12YWNjaW5lLWZvci1raWRzL9IBAA?oc=5

2021-10-07 14:00:51Z
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