Health Canada has granted authorisation for Pfizer’s unit Pfizer Canada and BioNTech’s Covid-19 vaccine, Comirnaty, as an initial three 3μg-dose regimen for usage in children aged six months to under five years.
This dosage was chosen as the preferred dose in children aged under five years based on safety, tolerability and immunogenicity findings.
The latest development is based on the findings from the randomised, controlled Phase II/III trial that enrolled 4,526 children of this age group.
Trial subjects were given the third 3μg dose of the vaccine a minimum of two months following the second dose when the Omicron variant of the SARS-CoV-2 virus was prevalent.
In accordance with the recommendations of the Canadian government and public health authorities across the country, the companies plan to commence shipping the 3μg paediatric vaccine doses following the authorisation.
The vaccine is intended for active immunisation for the prevention of Covid-19 in people aged six months and above in the country.
BioNTech is the Marketing Authorization Holder for the vaccine in the US, Canada, the European Union and the UK.
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.”
In June this year, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the vaccine as a three 3µg dose series for children aged six months to four years.