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COVID-19 Vaccine AstraZeneca
Published
Product name
COVID-19 Vaccine AstraZeneca
Active ingredient
ChAdOx1-S (Provisional Australian Biological Name)
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) was approved for the following therapeutic use:
COVID-19 Vaccine AstraZeneca has provisional approval for the indication:
Active immunisation of individuals ≥ 18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
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
The COVID-19 Vaccine AstraZeneca is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). Following administration, the S glycoprotein of SARS-COV-2 is expressed locally stimulating neutralising antibody and cellular immune responses.
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 Astra Zeneca was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
N/A
ARTG details: 349072