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.
More about 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 134 237 (8am-8pm seven days a week) – the NPS MedicineWise Adverse Medicine Events line
- Online form: TGA adverse event reporting
If you have an enquiry about the COVID-19 vaccine regulatory process, use the following contact details:
- Email: firstname.lastname@example.org(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)
- COVID-19 vaccine safety report - 09-03-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- COVID-19 vaccine safety report - 23-02-2023Information about the TGA's safety monitoring of COVID-19 vaccines.
- TGA grants provisional approval to Moderna’s COVID-19 bivalent (SPIKEVAX Bivalent Original/Omicron BA.4-5) booster dose vaccineOn 17 February, the TGA granted provisional approval to Moderna’s bivalent COVID-19 vaccine. This is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that has been provisionally approved by the TGA
- Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Davesomeran) Labelling Exemption 2023This instrument is made under section 39 of the current Poisons Standard.