On 29 August, the Therapeutic Goods Administration (TGA) provisionally approved Moderna's bivalent COVID-19 vaccine, elasomeran/imelasomeran (SPIKEVAX Bivalent Original/Omicron) for use as a booster dose in adults 18 years and over. This is the first bivalent COVID-19 vaccine approved for use in Australia.
The adapted vaccine triggers an immune response against two different COVID-19 variants: the original virus and the BA.1 Omicron variant. The vaccine should be administered at least 3 months after a primary series and/or previous booster dose with SPIKEVAX or other authorised COVID‑19 vaccine, in accordance with official recommendations.
The SPIKEVAX Bivalent Original/Omicron vaccine contains 25 micrograms of imelasomeran that targets the Omicron variant BA.1, and 25 micrograms of elasomeran that targets the original strain of SARSCoV-2. All other ingredients are the same as those used in Moderna's original COVID-19 vaccine.
The SPIKEVAX Bivalent Original/Omicron vaccine elicited a superior neutralising antibody response against Omicron BA.1 strain and a similar response against the ancestral strain, 28 days after use as a booster dose compared with the original SPIKEVAX vaccine. Initial analysis shows that the bivalent vaccine also generates a higher immune response against the sub-variants BA.4 and BA.5 than the original SPIKEVAX vaccine.
In making this regulatory decision, the TGA carefully considered data from an ongoing clinical study, which showed that the SPIKEVAX BIVALENT original/Omicron booster has a similar safety and reactogenicity profile to the original SPIKEVAX booster given as a second booster dose. No new safety signals were identified.
Provisional approval of this vaccine is subject to certain strict conditions, such as the requirement for Moderna to continue providing information to the TGA on longer term benefits from ongoing clinical trials and post-market assessment. The TGA will continue to actively monitor the safety of the vaccine both in Australia and through collaboration with our overseas counterparts. If safety concerns are identified, we will take action and promptly provide information to the public. As an extra check, the TGA laboratories will undertake batch assessment of each batch of the vaccine before it can be supplied in Australia.
TGA is the third major regulator to approve this product globally, and its decision was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields and including consumer representation.
The potential use of this vaccine in the national COVID-19 vaccination program is still to be determined. As with all COVID-19 vaccines, the Australian Technical Advisory Group on Immunisation (ATAGI) will provide advice to the Government on these matters in the coming weeks.
mRNA vaccines
SPIKEVAX Bivalent Original/Omicron (elasomeran/imelasomeran) is the third mRNA vaccine to receive provisional approval in Australia. mRNA vaccines use a synthetic genetic code called RNA to give our cells instructions about how to make the coronavirus' unique spike protein. When our body has made the protein encoded by the mRNA vaccine, it then recognises the spike protein as being foreign and launches an immune response against it. The RNA from the vaccine does not change, or interact, with our DNA in any way.
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- SPIKEVAX Bivalent Original/Omicron (elasomeran/imelasomeran) Product Information (PI)
- SPIKEVAX Bivalent Original/Omicron (elasomeran/imelasomeran) Consumer Medicine Information (CMI)
- SPIKEVAX Bivalent Original/Omicron (elasomeran/imesasomeran) decision summary
The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG. - AusPAR: Elasomeran/imelasomeran) - initial provisional registration, for use in individuals 18 years and older
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. - Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022