Pfizer and BioNTech's Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster Receives Health Canada Authorization for Individuals 12 Years of Age and Older
Retrieved on:
Friday, October 7, 2022
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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.
Key Points:
- 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.
- 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.