Canada has become the first country to approve the use of the Pfizer-BioNTech COVID-19 vaccine for children between the ages of 12 and 15.
Until Health Canada’s announcement of its approval Wednesday (May 5), the Pfizer vaccine was approved only for people 16 years and older.
Health Canada has determined that the shot was safe for children.
The U.S. is expected to follow Canada’s decision.
The vaccine is an mRNA vaccine. This means that it teaches cells how to make a protein that triggers an immune response. It does not use the live virus that causes COVID-19.
After that immune response is triggered, the body produces antibodies. In turn, the antibodies protect people from being infected should the virus enter their system in the future.
Canada’s approval is seen to speed up its immunization drive as it lags behind other countries in the Group of Seven.
In announcing the decision, the government described the measure as a light at the end of the tunnel.
Supriya Sharma, who works as chief medical adviser at the federal Health Canada agency, said that the Pfizer vaccine was safe and effective in the younger age group.
“We are starting to see the light at the end of the tunnel,” Sharma told media.
Canada’s federal government has bought tens of millions of doses of vaccines.
Alberta will become the first province to offer COVID-19 vaccines to everyone aged 12 and over, Premier Jason Kenney said.
Around a fifth or 20 percent of the 1,249,950 cases of COVID-19 in Canada have been reported in people under the age of 19.
Media reports say that the country has recorded 24,396 deaths.
“After completing a thorough and independent scientific review of the evidence, the department determined that this vaccine is safe and effective when used in this younger age group,” said Sharma.
Based on media reports, the authorization was based on the results of Pfizer-BioNTech’s Phase 3 clinical trial involving 2,260 adolescents aged 12 to 15.
The tests were conducted in the U.S. The trial found the vaccine to be 100 percent effective in children aged 12 to 15.
“While younger people are less likely to experience serious cases of COVID-19, having access to a safe and effective vaccine will help control the disease’s spread to their family and friends, some of whom may be at higher risk of complications,” Sharma said.
Sharma added: “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.”
The two-dose Pfizer vaccine was the first COVID-19 vaccine authorized in Canada.
The vaccine received regulatory approval in December 2020. It became the first COVID-19 vaccine to be administered in Canada.
“There are some provinces that have already provided some vaccine to this age group, if they were children that were at high risk,” Sharma noted.
“That was done off label, which is absolutely within their purview, so we do have some children in Canada that have already received a vaccine dose,” Sharma explained.
Pfizer Canada’s vaccine lead Fabien Paquette called the approva “a significant step forward in helping the Canadian government broaden its vaccination program and begin to help protect adolescents before the start of the next school year”.
BioNTech’s chief medical officer Ozlem Tureci said research continues on the use of the vaccine. There is a study going on into the safety and efficacy in children six months to 11 years of age.
Sharma said that Pfizer has indicated it could be submitting its submission to expand use to children ages five to 11 as early as September this year.