Canada on Wednesday authorized the Pfizer-BioNTech COVID-19 vaccine for ages 12 and over, becoming the first country to OK the shot for children under the age of 16.
Dr. Supriya Sharma, the chief medical adviser at Health Canada, said the decision was made because the vaccine is safe and effective in that age group. It is the first coronavirus vaccine approved for children in Canada.
“It will also support the return to a more normal life for our children, who have had such a hard time over the past year,″ she said, per the Associated Press.
Canada is the first country to authorize Pfizer for the 12-15 age group; the U.S. and the European Union are also reviewing it, with the U.S. Food and Drug Administration expected to authorize the Pfizer vaccine for young people by next week, setting up shots for many before the beginning of the next school year.
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The news comes after Pfizer in March announced that a Phase 3 trial involving its coronavirus vaccine in adolescents ages 12 to 15 was found to be safe and 100% effective. The BNT162b2 vaccine produced “robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old,” and that it was well tolerated, company officials said at the time.
The trial had enrolled 2,260 adolescents and saw 18 cases of COVID-19 among the placebo group, and none in the vaccinated group. Side effects were consistent with those seen in previous trials involving older participants ages 16 through 25. The participants will continue to be monitored for long-term protection and safety over the next two years.
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Pfizer has since requested their emergency use authorization with the FDA to also be extended to children 12 to 15 years old. The two-dose vaccine was granted EUA in December for those 16 years of age and older.
Fox News’ Alexandria Hein and the Associated Press contributed this report.