The Pfizer-BioNTech anti-Covid vaccine will be authorized for adolescents from 12 years old in Canada, which becomes the first country to approve it from that age, announced the Canadian Ministry of Health on Wednesday.

After carrying out a "rigorous and independent scientific review of known evidence", Health Canada concluded that the vaccine is "safe and effective" in preventing Covid-19 in adolescents aged 12 to 15, the ministry said in a statement.

Ottawa initially authorized the vaccine for people aged 16 and over.

100% effectiveness after the second dose

“The authorization of a first vaccine in Canada for the prevention of Covid-19 in children marks an important step in Canada's fight against the pandemic,” said Dr. Supriya Sharma, Chief Medical Advisor at Health Canada . She confirmed at a press conference that Canada was the "first" country in the world to authorize this vaccine from the age of 12. Since the start of the pandemic, around 20% of Covid-19 cases in Canada have been reported in people under the age of 19, she said.

Pfizer-BioNTech has also filed in the United States a request for extension of the emergency authorization of the vaccine for 12-15 year olds, and the decision of the United States Medicines Agency (FDA) is expected in the coming days. .

Canada's decision is based on "new data collected" after a large phase 3 clinical trial in the United States, expanded to more than 2,000 participants aged 12 to 15 years, said Health Canada.

"The data from the clinical trial showed that after the second dose, the prevention effectiveness of Covid-19 in this younger age group was 100%," assured the ministry.

"Temporary and mild" side effects

The safety profile of Pfizer-BioNTech's vaccine in 12 to 15 year olds is "similar" to that seen in older people, that is, the most commonly reported side effects were "temporary and mild. , such as arm pain, chills and fever, ”according to Health Canada. Other vaccine manufacturers licensed in Canada "are conducting or are planning to conduct studies in adolescents and children, including children 6 months to 11 years old," the ministry said.

Canada has approved four anti-Covid vaccines to date: those from Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson.

As part of this approval, Pfizer-BioNTech has committed to providing the ministry with additional information on "the safety, efficacy and quality of the vaccine" to ensure that "the benefits continue to outweigh the benefits. risks as it is administered to more people ”.

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