Moderna gets Health Canada authorization for second Omicron -targeting Bivalent booster
Cambridge: Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, has 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 2/3 trial studying mRNA-1273.214. A Phase 2/3 clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.
mRNA-1273.222 is the second Moderna bivalent COVID-19 vaccine approved by Health Canada, following the approval of mRNA-1273.214 (SPIKEVAXBivalent) in September. Clinical trial data showed that a booster dose of mRNA-1273.214 increased neutralizing geometric mean titers against Omicron BA.1 approximately 8-fold above baseline levels. Additional data showed that the higher antibody titers were sustained ninety days after administration.
In addition, mRNA-1273.214 demonstrated significantly higher neutralizing antibody responses against Omicron BA.4/BA.5 compared to mRNA-1273 28 days after administration. Potent responses were also seen against Omicron BA.2.75 28 days after administration, suggesting that the bivalent booster elicits broad cross-neutralization against Omicron variants.
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