Moderna Omicron-targeting bivalent COVID-19 booster vaccine gets Canadian approval
Cambridge: Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, has 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 agreement, the Government exercised its option to purchase an additional 4.5 million doses of a bivalent vaccine from Moderna, in addition to moving forward the scheduled delivery of 1.5 million bivalent doses from 2023 to 2022. There was also an agreement to convert an additional six million doses of the company's original COVID-19 vaccine (Spikevax, mRNA-1273) to mRNA-1273.214. Supply is expected to commence in early September.
"As the Omicron variant and its subvariants continue to spread broadly within Canada, there is a critical need to provide updated boosters designed to better match the circulating strain, particularly before respiratory virus season reaches its peak," said Patricia Gauthier, President and General Manager, Moderna Canada. "Today's mRNA-1273.214 approval provides Canadians with an important new tool in the fight against COVID-19 and a means of better protecting vulnerable populations."
In addition to Canada, Moderna has received approval for mRNA-1273.214 in the UK, Australia, and Switzerland and has completed regulatory submissions for the next-generation vaccine worldwide.
