Janssen Pharma who is wholly-owned by Johnson & Johnson (J&J), On June 25, 2021 were granted provisional registration by the TGA for their “COVID-19 Vaccine Janssen” for use in 18 years and over. This is the third “provisional use” vaccine in Australia, and the first one-dose COVID-19 vaccine, which was first submitted for determination on November 16, 2020. [4]
The active ingredient is “adenovirus serotype 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2.S)” as stated in the public assessment report, together with a list of it’s excipients. [1, 2, 3]
The approval decision was made on preliminary short term efficacy and safety data, and is thus under ongoing clinical and post-market assessment under black triangle scheme.