COVID-19 vaccine: Janssen

Provisional approval

On 25 June 2021 the Therapeutic Goods Administration (TGA) granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.

This viral vector vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation for the prevention of coronavirus disease-2019 (COVID-19) in adults greater than or equal to 18 years of age. The official recommendation is for this vaccine to be given in a single dose.

Provisional approval of this vaccine is subject to certain strict conditions, such as the requirement for Janssen-Cilag Pty Ltd to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Australian supply

The Janssen vaccine is not included in Australia's COVID-19 vaccination program.

Information about Australia's vaccine roll out can be found on the Department of Health's webpage.

Viral vector vaccines

This is the second viral vector vaccine to receive provisional approval. Vector vaccines use a non-pathogenic, human adenovirus virus (known as the viral vector) that contains the genetic code for a protein unique to the coronavirus, the spike protein. Once this enters the body, it instructs our cells to make the coronavirus spike protein. Our cells use these instructions to make copies of the protein. Our immune cells then recognise the spike protein as foreign and begin building an immune response against it.

Australians can be confident that the TGA's review process of the Janssen vaccine 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. Further information from ongoing clinical trials and post-market monitoring will be provided in coming months.

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:

• Product information (PI)
• Consumer Medicine Information (CMI)
• COVID-19 Vaccine Janssen 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: Ad26.COV2.S
  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.