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Health Canada Authorizes Moderna's Omicron-Targeting Bivalent COVID-19 Booster Vaccine
mRNA-1273.214 is the first Omicron-targeting bivalent COVID-19 booster vaccine approved in CanadaStudy results show mRNA-1273.214 has demonstrated
About this update from Moderna, Inc.
[{"type":"text","content":"mRNA-1273.214 is the first Omicron-targeting bivalent COVID-19 booster vaccine approved in CanadaStudy results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 subvariants when compared with mRNA-1273Approval follows agreement with the Government of Canada to supply 12 million doses of Omicron-targeting bivalent COVID-19 boostersCAMBRIDGE, MA / ACCESSWIRE / September 1, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Health Canada has authorized the use of its Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) 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. Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that targets both the original strain of SARS-CoV-2 and the Omicron variant of concern (BA.1).\"Health Canada's decision to approve mRNA-1273.214 reinforces the power of our mRNA technology platform, which has enabled us to quickly advance bivalent vaccines that may offer superior protection against Omicron BA.1 and the BA.4 and BA.5 subvariants,\" said Arpa Garay, Chief Commercial Officer at Moderna. \"We believe the potential of mRNA-1273.214 to provide broad immunity to Omicron variants may help Canadians stay ahead of the COVID-19 virus as we move into the fall and winter months.\"The Health Canada decision is based on clinical trial data from a phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants. A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. Additional analysis showed mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age.On August 22, 2022, Moderna announced an agreement with the Government of Canada to supply 12 million doses of Omicron-containing bivalent COVID-19 boosters. As part of that agreeme...