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COVID-19 Vaccine Janssen
Published
Product name
COVID-19 Vaccine Janssen
Active ingredient
Adenovirus serotype 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2.S)
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
COVID-19 Vaccine Janssen (Ad26.COV2.S) was provisionally approved for the following therapeutic use:
COVID-19 Vaccine Janssen has provisional approval for the indication:
COVID-19 Vaccine Janssen is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
How this medicine works
COVID-19 Vaccine Janssen is a monovalent vaccine composed of a recombinant, replication incompetent human adenovirus type 26 vector that encodes a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike (S)-glycoprotein in a stabilised conformation. Following administration, the S-glycoprotein of SARS‑CoV‑2 is transiently expressed, stimulating both neutralising and other functional S-specific antibodies, as well as cellular immune responses directed against the S-antigen, which may contribute to protection against coronavirus disease 2019 (COVID-19).
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of COVID-19 Vaccine Janssen was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
N/A
ARTG details: 350150