As soon as the regulator gives the green light, suppliers will be able to begin offering the COVID-19 vaccine to children, although new doses for children may have to be purchased. Doses are about a third of the size given to adults and adolescents 12 years and older.
The vaccine was developed in partnership with German BioNTech and is now marketed under the brand Comirnaty. It was approved for people aged 16 and over last December, and for children between 12 and 15 in May.
Pfizer already submitted clinical trial data for its pediatric dose to Health Canada earlier this month and made a formal request for approval to the U.S. Food and Drug Administration last week.
The company said the results were comparable to those seen in the Pfizer-BioNTech study in people aged 16 to 25.
“Thorough scientific examination” required before authorization
In a statement, Health Canada said it would prioritize review of the submission, while maintaining high scientific standards for safety, efficacy and quality.
“Health Canada will only authorize the use of Comirnaty if the independent and thorough scientific review of all data included in the submission has shown that the benefits of the vaccine outweigh the potential risks in this age group,” indicates the press release.
The Pfizer-BioNTech vaccine has also been tested on children as young as six months old. The first data for children under five are expected at the end of the year.
Health Canada said it expects to receive more data for review from Pfizer for younger age groups, as well as other manufacturers for various age groups in the coming months.
Once the vaccine is approved for children, the National Advisory Committee on Immunization (NACI) will determine whether the benefits of the vaccine outweigh the potential risks to young children. The Public Health Agency of Canada has reported rare incidents of myocarditis, an inflammation of the heart muscle, after receiving an mRNA vaccine such as Pfizer-BioNTech and Moderna.
As of October 1, Health Canada had documented 859 vaccine-associated cases, which appear to primarily affect people under the age of 40. It’s over millions of doses administered.
The risk of myocarditis appears to be low, according to Tim Sly, a Ryerson University epidemiologist with expertise in risk management.
“Of course, no one considers any complication in a child to be acceptable, and great caution is taken to research and identify any problems,” Sly said in a recent email exchange with The Canadian Press.
A COVID-19 infection carries a very high risk of cardiovascular problems, he noted.
In addition to protecting children from more severe symptoms of COVID-19, the vaccine would also reduce the risk of a child transmitting the virus to a vulnerable family member and create a better school environment with less stress from transmission. .