The approval was based on the results from a Phase 2/3 randomised, controlled trial on 4,526 kids aged six months to below five years

vaccine-g83a734c38_1920

Pfizer Canada and BioNTech announced Health Canada’s authorisation for the COMIRNATY COVID-19 vaccine. (Credit:torstensimon from Pixabay)

Pfizer Canada and BioNTech announced Health Canada’s authorisation for their Comirnaty Covid-19 vaccine, as a three 3-μg primary series for children six months to less than five years of age.

The 3-μg dosage was chosen as the recommended amount for kids under the age of five based on the safety, tolerability, and immunogenicity evidence.

The health administration stated that the evidence provided supported the vaccine’s efficacy and safety in preventing Covid in the target age range.

Pfizer Canada mRNA Vaccines & Antiviral Portfolio lead Fabien Paquette said: “We know many parents in Canada have at heart to provide further protection for their children under five.

“With this Health Canada authorisation, we have achieved another key milestone in our ongoing effort to help protect families and communities against Covid-19.”

The approval was based on the results from a Phase 2/3 randomised, controlled trial on 4,526 kids aged six months to below five years old.

During the experiment, when Omicron was the predominant variation, kids were given the third 3-μg dosage at least two months following the second treatment.

In that age group, the vaccine’s benefit-risk profile was favourable for use as a three-dose primary series, with the first two doses administered three weeks apart and the third dose administered at least eight weeks following the first.

BioNTech CEO and co-founder Ugur Sahin said: “We are committed to providing access to our Covid-19 vaccine to all age groups.

“As of today, Canadian families have access to an authorized vaccine helping to protect their youngest children against Covid-19.”

In accordance with recommendations from public health organisations across Canada and Pfizer, 3-μg paediatric dosages will start to be shipped.

Comirnaty, also known as the Pfizer-BioNTech COVID-19 Vaccine, is based on the unique mRNA technology of BioNTech.

BioNTech holds marketing authorisations in Canada, the US, European Union, and the United Kingdom along with holding emergency use authorisations or equivalents in the US (jointly with Pfizer) and other nations.

In April this year, both companies filed a EUA application to the FDA for a 10µg booster dose of their Comirnaty Covid-19 vaccine in children aged five to 11 years.