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
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News articlesCOVID-19 vaccines that have received a provisional determination from the TGA.
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PageUnderstand the regulatory process of how a COVID-19 vaccine application is submitted and assessed before the vaccine is approved for supply in Australia.
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PageThe current regulatory status of COVID-19 vaccines in Australia.
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PageInformation on how the TGA monitors COVID-19 vaccine safety, reporting suspected side effects and COVID-19 safety updates.
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PageFind information on COVID-19 vaccines that are used in other countries that we recognise in Australia.
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PageFind answers to common questions about how the TGA assesses and monitors a vaccine for safety, quality and effectiveness.
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PageInformation for sponsors on the regulatory requirements and processes for COVID-19 vaccines.
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PageLearn how the TGA is collaborating with international regulators to provide timely access to COVID-19 vaccines.
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)
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