The regulatory approval for Comirnaty Original & Omicron BA.4/BA.5 booster dose is based on the clinical data obtained from the companies’ monovalent, Omicron BA.1-adapted bivalent vaccine.
Additionally, the authorisation was granted based on pre-clinical and manufacturing results from Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine.
A clinical trial of the vaccine is currently underway in individuals aged 12 years and above.
It has been designed for evaluating the vaccine’s tolerability, safety, and immunogenicity.
The data from the trial will be provided to the authorities in the coming months.
BioNTech CEO and co-founder professor 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 programme 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.”
The Comirnaty Original & Omicron BA.4/BA.5 vaccine comprises 15-μg of mRNA expressing the wild-type spike protein of SARS-CoV-2, and 15-μg of mRNA encoding the BA.4/BA.5 subvariants’ spike protein.
Pfizer Canada, mRNA Vaccines & Antiviral Portfolio lead Fabien Paquette said: “This is another important milestone in our ongoing efforts to provide protection against this virus.
“Pfizer will be making significant volumes of the vaccine available in the coming days.”
Pfizer Canada and BioNTech are planning to submit an application to Health Canada for the Omicron BA.4/BA.5-adapted bivalent vaccine in children aged five to 11 years for review.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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