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COVID-19 vaccine: SPIKEVAX (elasomeran)
COVID-19 vaccine: Spikevax (elasomeran) approved for use in individuals aged 12 years and older
On 3 September 2021 the Therapeutic Goods Administration (TGA) granted provisional approval to Moderna Australia Pty Ltd for the use of its COVID-19 vaccine—SPIKEVAX (elasomeran)—in individuals aged 12 years and older.
This decision follows the provisional approval granted by the TGA to SPIKEVAX (elasomeran) on 9 August 2021 for use in individuals aged 18 years and older. As for previous COVID-19 vaccine applications, this assessment was expedited by the TGA through the provisional approval pathway. The TGA has decided that this vaccine meets the high safety, efficacy and quality standards required for use in Australia following a thorough and independent review of Moderna’s submission.
This messenger RNA (mRNA) vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 in individuals 12 years of age and older.
The recommended dose and dose interval is the same as that for the adult population - two full doses given 28 days apart. Further information is available in the Product Information (PI).
The Moderna COVID-19 vaccine has shown strong efficacy preventing symptomatic COVID-19 and severe COVID-19 in clinical trials. The vaccine has also received regulatory approval or authorisation in several countries and is being widely used in the United Kingdom, Canada, the European Union, the United States, Switzerland and Singapore.
Provisional approval of this vaccine in Australia is valid for two years and means it can now be lawfully supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for Moderna Australia Pty Ltd to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
Information about Australia's vaccine roll out can be found on the Department of Health's webpage.
SPIKEVAX (elasomeran) is the second 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.
Australians can be confident that the TGA's review process of SPIKEVAX (elasomeran) was rigorous. The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
The TGA will continue to monitor the safety of SPIKEVAX (elasomeran) both in Australia and overseas and will not hesitate to take action if safety concerns are identified. As an extra check, the TGA laboratories will undertake a batch assessment of each batch of the vaccine before it can be supplied in Australia.
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 (elasomeran) Product information (PI)
- SPIKEVAX (elasomeran) Consumer Medicine Information (CMI)
- SPIKEVAX (elasomeran) 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 - initial provisional registration
- AusPAR: Elasomeran - Extension of indication, use in individuals 12 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) Labelling Exemption 2021
- Post-approval changes to COVID-19 vaccines
- 4 September 2021 – Extension of indication – use in individuals 12 years or older