Health Canada has approved Moderna Inc's MRNA omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), as a booster dose for individuals 18 years of age and older.
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.
In August, Moderna announced an agreement with the Government of Canada to supply 12 million doses of Omicron-containing bivalent COVID-19 boosters.
Concurrently, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended conditional approval for Moderna's updated COVID-19 vaccine for individuals 12 years and older.
The EMA also backed the approval of Pfizer Inc PFE and BioNTech SE's BNTX adapted COVID-19 booster vaccines.
Data from a study involving over 600 adults who had previously received three doses of Pfizer/BioNTech's COVID-19 shot showed that the immune response to Omicron BA.1 was higher in people who received a booster with a vaccine containing only the Omicron BA.1 component than in those given a booster with the original vaccine.
The European regulator also recommended authorizing the use of Novavax Inc's NVAX Nuvaxovid as a booster dose for adults who have received the same or another COVID-19 vaccine for their initial vaccination.
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