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COVID-19 vaccines

14 April 2021

We will rigorously assess any COVID-19 vaccine for safety, quality and effectiveness before it can be supplied in Australia. This page will be regularly updated to keep consumers, health professionals and sponsors informed of the latest regulatory developments. For news and information on the roll-out strategy visit Department of Health: COVID-19 vaccines.

COVID-19 vaccine approval process

Understand the regulatory process of how a COVID-19 vaccine application is submitted and assessed before a vaccine is approved for supply in Australia.

Provisional registrations

COVID-19 vaccines that have been provisionally approved for use in Australia.

COVID-19 vaccine safety monitoring and reporting

Learn how the TGA continues to monitor the safety of vaccines after they are registered in Australia so that we can detect and respond to any safety concerns.

News and updates

Read the latest COVID-19 vaccine news and other updates.

COVID-19 vaccine advertising and import compliance

Find information on complying with the rules around advertising and importing COVID-19 vaccines

Information for consumers and health professionals

Find out answers to the common types of questions you may have about how the TGA assesses and monitors a vaccine for safety, quality and effectiveness.

Information for sponsors (industry)

Find information and guidance about the regulatory requirements and processes.

International collaboration

Learn how the TGA is collaborating with international regulators to provide timely access to a COVID-19 vaccine.

Report a side effect

If you think you have experienced a side effect from the COVID-19 vaccine you can report it via:

  • Telephone: 1300 134 237 (8am-8pm seven days a week) – the NPS MedicineWise Adverse Medicine Events line
  • Online form: TGA adverse event reporting

Contact us

If you have an enquiry about the COVID-19 vaccine regulatory process, use the following contact details:

  • Email: info@tga.gov.au
  • Telephone: 1800 020 653 (free call within Australia)

If you have a general enquiry about COVID-19 or the vaccine roll-out, contact the National Coronavirus Helpline on:

  • Telephone: 1800 020 080 (available 24 hours a day, seven days a week)