Pfizer and BioNTech announced successful trials with their COVID-19 vaccine in five- to 11-year olds and that they will be appealing to Health Canada to authorize their vaccine.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech.
“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The newly-named Comirnaty vaccine (also known as the Pfizer vaccine) is based on mRNA technology and was administered to children during trials using a similar two-dose regimen administered 21 days apart. Pfizer and BioNTech said their COVID-19 vaccine trials have induced a robust immune response in elementary-school aged children.
Children received a smaller dose – about more than a third – than those aged 12 and older.
In a written statement, Pfizer and BioNTech said that the smaller dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity.
These are the first results from a trial of a COVID-19 vaccine in this age group.
With pediatric cases of COVID-19 having risen about 240 percent in the US, Pfizer and BioNTech said that they plan to urgently submit authorization to the FDA and other regulators, including Health Canada.
News comes as the Delta variant infects more and more unvaccinated Canadians and school goes back to in-person teaching.