Pfizer Canada and BioNTech have received Health Canada’s approval for COMIRNATY Original & Omicron BA.4/BA.5 to be given as a 30-μg booster dose for people aged 12 years and above.

The authorisation has been driven by clinical data from Pfizer and BioNTech’s Monovalent (original vaccine), Omicron BA.1-adapted bivalent vaccine along with pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine.

Pfizer Canada said that a clinical study studying the tolerability, safety, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is currently in progress.

The vaccine includes 15-μg of mRNA encoding the spike protein of the wild form of SARS-CoV-2 and 15-μg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. It can target both the original variant as well as the two Omicron subvariants, the firm said.

According to Pfizer Canada, a single mRNA strand can target both the Omicron BA.4 and BA.5 variants since they both have the same spike protein amino acid sequences.

All other elements of the vaccine are the same, with the exception of the insertion of the mRNA sequence for the Omicron BA.4/BA.5 spike protein.

BioNTech co-founder and CEO Ugur Sahin said: “Today’s approval allows us to make our Omicron BA.4/BA.5-adapted bivalent vaccine available to the people in Canada to support the continued vaccination program in advance of the winter season.

“The bivalent BA.4/BA.5 vaccine aims to provide broader immunization against COVID-19 caused by the current dominant Omicron sublineages and previous variants of concern.

“It marks a further milestone in addressing this continuously evolving virus.”

BioNTech and Pfizer have developed the COMIRNATY and COMIRNATY Original and Omicron BA.4/BA.5 based on the former’s proprietary mRNA technology.

Additionally, both companies are planning to submit an application for a bivalent Omicron BA.4/BA.5 vaccination for kids aged five to 11 years to Health Canada for review.