COVID-19 vaccine: SPIKEVAX (elasomeran)

On 21 April, the TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration. This is the first COVID-19 vaccine to have received full registration.

In making this decision, the TGA carefully considered long-term follow-up data from a number of studies that confirmed the safety and efficacy for SPIKEVAX. These studies showed a continued immune response after a 2-dose primary series and booster dose. Importantly, no new safety concerns were identified.

The decision to grant full registration was informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation. The Australian Public Assessment Report (AusPAR) for this decision will be published in the coming days.

As with all medicines, the TGA’s assessment was rigorous, independent and based on evidence. The safety and efficacy of SPIKEVAX is also supported by real-world use in millions of people worldwide, providing reassurance about the safety of these vaccines. Vaccination remains the most effective way to protect yourself from serious disease, hospitalisation and death.

The regulatory status of all COVID-19 vaccines can be found at https://www.tga.gov.au/products/covid-19/covid-19-vaccines.

What is provisional registration?

The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines, or new uses of existing medications, with preliminary clinical data.

Provisional registration is limited to a maximum of six years. Sponsors may apply for full registration once they believe sufficient clinical data are available. However, if sufficient data can’t be supplied, then the provisional registration will lapse at the end of the specified period.

Supporting regulatory documents

• 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, 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.
• AusPAR: Elasomeran - Extension of indication, use in individuals 12 years and older
• AusPAR: Elasomeran - Booster dose in individuals 18 years and older
• AusPAR: Elasomeran - Extension of indication, use in individuals 6 years and older
• AusPAR: Elasomeran - Extension of indication, use in individuals 6 months and older
• AusPAR: Elasomeran - Booster dose in individuals aged 12 years and older
• AusPAR: Elasomeran – Transition to full registration, for use in individuals in individuals aged 6 years and older
  • Note: use in individuals less than 6 years of age remains provisionally approved
• Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) Labelling Exemption 2021 (repealed)
• Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran) Labelling Exemption 2022