Canada becomes the first country to approve Pfizer Covid-19 vaccine for children aged 12-15

Health Canada based its decision on data from Phase 3 clinical trial in participants aged 12 to 15 years old. The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Canada becomes the first country to approve Pfizer Covid-19 vaccine for children aged 12-15
Canada becomes the first country to approve Pfizer Covid-19 vaccine for children aged 12-15
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"After completing a thorough and independentscientific review of the evidence, the department determined that this vaccineis safe and effective when used in this younger age group," said HealthCanada's Chief Medical Advisor Supriya Sharma at a press conference onWednesday.

Canada became the first country in the world to haveokayed the two-dose Pfizer vaccine shots to the younger age group, the Xinhuanews agency reported. The Canadian government authorized the vaccine for use inindividuals 16 years of age and older last December.

Health Canada based its decision on data from Phase 3clinical trial in participants aged 12 to 15 years old. The trial enrolled2,260 adolescents 12 to 15 years of age in the United States. All participantsin the trial will continue to be monitored for long-term protection and safetyfor an additional two years after their second dose.

"After completing a thorough and independentscientific review of the evidence, the department determined that this vaccineis safe and effective when used in this younger age group," said Sharma.

"While younger people are less likely to experienceserious cases of Covid-19, having access to a safe and effective vaccine willhelp control the disease's spread to their family and friends, some of whom maybe at higher risk of complications," Sharma said. "The most commonlyreported side effects were temporary and mild, like a sore arm, chills orfever."

Usually, the vaccine submission review process can takemuch longer, but because of an emergency order, Health Canada has been able toexpedite the authorization process.

Health Canada has published a series of documentsdetailing its decision and a summary of the evidence reviewed. Pfizer-BioNTechis required to continue providing Health Canada with ongoing safety andefficacy information as the product is being used in real-world settings.

With nearly 11 million doses sent to Canada to date,Pfizer has committed to sending more than 2 million doses each week, until the endof June.

Asked what this might mean for schools to be able toreopen, Sharma said that will depend on how and when provinces and territoriesin Canada decide to administer these shots to younger people.

As of Wednesday noon, Canada reported a cumulative totalof 1,253,817 Covid-19 cases, including 24,445 deaths and 130,008 variants,according to CTV.

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