Pfizer Canada ULC and BioNTech SE announced that Health Canada authorized the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) for ages 6 months and older. The updated vaccine will be available in Canada as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. For children 6 months through 4 years of age the updated vaccine is authorized for administration as a three-dose series in those without a history of completion of a COVID-19 primary vaccination course, or as a single dose for those with a history of completion of a COVID-19 primary vaccination course.
The authorization of is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 Vaccines. Further, the application included pre-clinical data on the neutralization potential of serum antibodies induced by the updated monovalent COVID-19 vaccine against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3 and EG.5.1 (Eris).
Pfizer and BioNTech continue to monitor emerging SARS-CoV-2 strains and continue to conduct studies to monitor the vaccine’s effectiveness, including the recently emerged Omicron BA.2.86 (Pirola) variant and the globally dominant EG.5.1 (Eris) subvariant.
“With today’s Health Canada authorization, individuals 6 months and older in Canada are eligible to receive the XBB.1.5-adapted COVID-19 vaccine, even if they have never been vaccinated against COVID-19 before,” said Andréa Mueller, Primary Care Portfolio Lead, Pfizer Canada. “We are proud of this achievement that empowers Canadians to protect themselves against the XBB sublineages, which are currently the most dominant strains in Canada. We expect the newly formulated vaccine to be available in Canada in the coming weeks to ensure people can get their updated COVID-19 vaccine ahead of the fall/winter season when respiratory viruses are expected to peak.”
“As COVID 19 is expected to become a seasonal disease, similar to influenza, it remains our goal to provide COVID-19 vaccines that are adapted to the respective circulating virus variants or sublineages to the people worldwide,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The new variant-adapted monovalent vaccine aims to further improve protection against severe illness and hospitalization caused by Omicron XBB descendent sublineages that are antigenically distant from prior Omicron strains.”
The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron BA.4/BA.5; COMIRNATY Omicron XBB.1.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
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