COVID-19 vaccines
Find out how we approve and regulate COVID-19 vaccines in Australia.
We 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 COVID-19 vaccine roll-out strategy visit Department of Health and Aged Care: COVID-19 vaccines.
COVID-19 vaccine regulation
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 633 424 (9am-5pm AET, Monday to Friday) or visit www.1300medicine.com.au
- 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(link sends e-mail)
- 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)
Latest articles
- COVID-19 vaccine safety report - 02-11-23In line with the official end of the COVID-19 emergency response, this will be our last regular COVID-19 Vaccine Safety Report. We will continue safety monitoring of COVID-19 vaccines.
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine-Pfizer) (Raxtozinameran) Labelling Exemption 2023We've granted a labelling exemption for the COVID-19 Vaccine, Pfizer (raxtozinameran), under the current Poisons Standard.
- COVID-19 vaccine safety report - 19-10-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
Latest publications
- ACV meeting statement, Meeting 45, 4 October 2023Advisory Committee on Vaccines meeting statement for meeting 45, held on 4 October 2023.
- ACV meeting statement, Meeting 46, 29 November 2023Advisory Committee on Vaccines meeting statement for meeting 46, held on 29 November 2023.
- ACV meeting statement, Meeting 44, 2 August 2023Advisory Committee on Vaccines meeting statement