One more step towards vaccination of adolescents! The Canadian Department of Health announced on May 5 that it was authorizing the use of the anti-Covid Pfizer-BioNTech vaccine for adolescents as young as 12 years old. Canada thus becomes the first country to approve it from that age.
“The authorization of a first vaccine in Canada for the prevention of Covid in children marks an important step in Canada’s fight against the pandemic,” said Dr. Supriya Sharma, Chief Medical Advisor at Health Canada.
Read also: The Pfizer vaccine would be 100% effective in 12-15 year olds
First country to authorize vaccine for adolescents
“We are the first in the world to authorize the Pfizer (vaccine) for 12-15 year olds,” she said at a press conference, adding that the UK and the European Union are 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.
2000 clinical trial participants
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.
A “safe and effective” vaccine
The safety profile of Pfizer-BioNTech’s vaccine in 12 to 15 year olds is “similar” to that seen in older people. Indeed, the most commonly reported side effects were “temporary and mild, such as arm pain, chills and fever,” according to Health Canada.
Health Canada therefore concluded that the vaccine was “safe and effective” in preventing Covid in adolescents as young as 12 years old. 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.
Since the start of the pandemic, around 20% of Covid 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 for the past year,” she added.