TGA Australia approves COVID-19 vaccine Janssen to prevent COVID-19 – Janssen Cilag Pty. Ltd.

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. The Janssen vaccine has been shown to prevent COVID-19; however, it is not yet known whether it prevents transmission or asymptomatic disease.