Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster receives Health Canada authorization for individuals 12 years of age and older.- Pfizer + BioNTech SE .
Pfizer Canada ULC and BioNTech SE nnounced that Health Canada has authorized Comirnaty Original & Omicron BA.4/BA.5 as a 30-?g booster dose for individuals ages 12 years and older.
An application for an Omicron BA.4/BA.5-adapted bivalent vaccine for children 5 through 11 years of age is also being planned for submission to Health Canada for review.
The authorization of Comirnaty Original & Omicron BA.4/BA.5 is based on clinical data from Pfizer and BioNTech’s monovalent (“original” vaccine), Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine. A clinical study investigating the safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is currently underway. This data will be provided to the authorities in the coming months.
Pfizer and BioNTech’s bivalent COVID-19 vaccine contains 15-?g of mRNA encoding the spike protein of the wild-type of SARS-CoV-2, and 15-?g of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Because the Omicron BA.4 and BA.5 variants contain identical spike protein amino acid sequences, both can be targeted with a single mRNA strand. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.
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