Approvals and decisions about vaccines


Following a review of the use of the COVID-19 AstraZeneca vaccine, the Australian Technical Advisory Group on Immunisation (ATAGI) recommends that the COVID-19 vaccine by Pfizer is preferred over the COVID-19 vaccine by AstraZeneca in adults aged under 50 years. Find out more.

Who decides if the covid-19 vaccines are safe?

The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.

The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.

The TGA is assessing all COVID-19 vaccines being used, or proposed for use, in Australia. Vaccines are assessed based on how safe they are, and how effective they are. The TGA is responsible for continuing to monitor and enforce safety and efficacy of the vaccines after they approved.

If a problem is discovered, the TGA can take action. Possible regulatory actions vary from continued monitoring to withdrawing the product from the market.

Who decides who gets the vaccines?

The Australian Technical Advisory Group on Immunisation (ATAGI) advises the Commonwealth government on immunisation, and have been on the immunisation program for COVID-19 vaccines as they become available in Australia.

ATAGI helped develop the national rollout plan for the COVID-19 vaccines, and are continuing to provide robust clinical advice on issues such as the use of the COVID-19 vaccines in children, women who are pregnant, and older people.

ATAGI have developed the Australian Immunisation Handbook, which provides clinical guidelines for healthcare professionals and others about using vaccines safely and effectively.

An ATAGI COVID-19 Working Group has been formed to:

  • Provide technical advice to the Minister for Health on the immunisation program for COVID-19 vaccines as they become available in Australia.
  • Identify and prioritise gaps in the immunisation landscape to improve impact, confidence and equity with the use of COVID-19 vaccines.
  • Advise on the content of clinical and other communication materials, including updating the Australian Immunisation Handbook for any COVID-19 vaccines.
  • Consult with the Communicable Diseases Network Australia (CDNA) and the Advisory Committee on Vaccines (ACV) and other national committees on matters relating to the implementation of immunisation policies, procedures and vaccine safety related to COVID-19 vaccines.

Who is monitoring the rollout?

The Therapeutic Goods Administration (TGA) is responsible for monitoring the safety of all vaccines approved for use in Australia. TGA has put in place a comprehensive system to capture reports of adverse events following COVID-19 vaccination, through:

AusVaxSafety is a world-leading national vaccine safety system, coordinated by the National Centre for Immunisation Research and Surveillance (NCIRS) and funded by the Australian Government Department of Health.

AusVaxSafety will be conducting comprehensive active safety monitoring of COVID-19 vaccines. This is to ensure the safety of COVID-19 vaccines and provide clinician and consumer confidence in the vaccination program.

AusVaxSafety will be following up with vaccine recipients three days and then eight days after each dose, and six weeks after the final dose.