“The authorization of a first vaccine in Canada for the prevention of Covid-19 in people over 12 years old marks an important step in Canada's fight against the pandemic,” said Dr. Supriya Sharma, Chief Medical Advisor at Health Canada.
Ottawa becomes the first capital to approve it from that age.
"We are the first in the world to authorize the Pfizer (vaccine) for 12-15 year olds," she told a press conference, adding that the UK and the European Union were also considering right now the same data Canada used to make its decision.
A decision by the United States Medicines Agency (FDA) on the extension of the Pfizer vaccine to this same age group is also expected in the coming days.
100% effectiveness at the second dose
Canada based its decision 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%", compared to more than 90% in adults, assured the ministry.
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.
The same vaccines as in France
Pfizer-BioNTech filed its request to extend the vaccination age to the Canadian government on April 16.
Pfizer and other vaccine manufacturers licensed in Canada "are either conducting or planning to conduct studies in adolescents and children, including children 6 months to 11 years of age," the ministry said.
"An accelerated review" of these studies will be done by the Canadian ministry as soon as it receives requests from the laboratories, specifies Health Canada.
Canada has approved four anti-Covid vaccines to date: those from Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson.
Canada had more than 1.2 million cases of coronavirus on Wednesday since the start of the pandemic, and more than 24,000 deaths.
About 35% of the 38 million Canadians received a first dose of the vaccine.
20% of cases in people under 19
Since the start of the pandemic, around 20% of Covid-19 cases in Canada have been detected in people under the age of 19, said Dr Sharma.
“The vaccination will support the return to a more normal life for our children, who have had to go through a difficult period in the past year,” she said.
In addition, two new deaths have been reported in Canada in the past 24 hours related to the AstraZeneca vaccine, bringing the total number in this country to three.
This vaccine and that of Johnson & Johnson have caused rare but serious blood clots around the world among the millions of people in whom they have been administered.