Therapeutic Goods Administration provisionally approves Omicron-containing bivalent booster vaccine, MRNA-1273.214, for Australia
Moderna, Inc. announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional approval for its Omicron-containing bivalent booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older
Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.1).
The decision from the TGA is based on clinical trial data from a phase II/III 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 previously uninfected participants. A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, 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. mRNA-1273.214's reactogenicity and safety profile is consistent with the currently authorized Spikevax (mRNA-1273) booster.
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