Health Canada authorises mRNA-1273.222 as an Omicrom targeted bivalent booster
Moderna, Inc. announced Health Canada has authorized the use of its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, as a booster dose for active immunization against COVID-19 caused by the SARS-CoV-2 virus in individuals 18 years of age and older
The 50 µg booster dose of mRNA-1273.222 includes 25 µg of mRNA encoding for the spike protein of BA.4/BA.5 and 25 µg encoding for the original strain of the SARS-CoV-2 virus.
"This approval demonstrates that our mRNA platform enables rapid development of vaccines and various options to address variants of concern," said Patricia Gauthier, President and General Manager, Moderna Canada. "We are proud to collaborate with Health Canada to bring Omicron-targeting bivalent vaccines to Canada to help broaden population immunity and protect Canadians against current and potential future variants of concern."
Health Canada's authorization of mRNA-1273.222 was based both on pre-clinical data for mRNA-1273.222 as well as clinical data from a Phase II/III trial studying mRNA-1273.214. A Phase II/III clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.