Approval of a COVID-19 Vaccine - Auslan

Last updated: 5 March 2021

Transcript

Vaccines are one of the most effective way to protect against diseases like COVID-19.

Before COVID-19 vaccines can be given to people in Australia, they must first be approved by our world leading regulator, the Therapeutic Goods Administration – known as the TGA.

They regulate and approve all vaccines, medicines, and other medical goods in Australia.

All potential COVID-19 vaccines are currently going through rigorous testing processes. They will be carefully assessed for safety, quality and effectiveness before they can be approved.

COVID-19 vaccines will only be approved if clinical trials can show the benefits to Australians against COVID-19.

To be approved it must pass a comprehensive six stage process, and the TGA will not cut corners:

A pharmaceutical company – or sponsor – must submit a pre-application. The TGA will look at this against clinical data and the need for the vaccine.

If the application meets the TGA's requirements, the sponsor can then apply to register the vaccine for use in Australia. At this point they must include a significant amount of clinical and non-clinical information to support the request. Next, the experts at the TGA look at the available data. They can ask for more information to fill any gaps, and they can also ask for independent advice.

Once the vaccine is fully evaluated, the TGA will decide whether to provide what they can for an initial registration.

The vaccine can now be registered and be supplied in Australia.

All registered vaccines are closely monitored by the TGA, who will respond to any safety issues. COVID-19 vaccines will be no different.

The TGA will also be checking all the COVID-19 batches before they are released for rollout. The first approved vaccines will go to priority groups. Until we all get vaccinated, it's important that we continue to be COVID safe by practising good hygiene, physical distancing and getting tested.

To learn more, visit tga.health.gov.au