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TGA advice on recognition of COVID-19 vaccines not registered in Australia but used internationally

1 October 2021

The Therapeutic Goods Administration (TGA) has undertaken an assessment on the protection offered by certain COVID-19 vaccines that are administered in certain countries but not currently registered in Australia.

It is based on individual assessment of published data and in certain cases regulatory information provided in confidence. This advice is subject to change as new information becomes available.

In this initial report the TGA assessed six vaccines that have been widely deployed in the Asia-Pacific region, as well as in national vaccination programs in countries such as China and India from which Australia normally receives many international arrivals.

Following assessment to determine the protection offered by certain of these vaccines against infection and serious illness, TGA's initial advice is that Coronavac (Sinovac) and Covishield (AstraZeneca/Serum Institute of India) vaccines be considered 'recognised vaccines' for incoming international travellers to be regarded as appropriately vaccinated.

The assessments have been based on individual review of published data and in certain cases of regulatory information provided to the TGA in confidence. "Recognition" status does not constitute Australian regulatory approval, as regulatory approval would enable a company to provide that vaccine for administration within Australia.

At this point in time, TGA has received insufficient data to reach a conclusion as to the protection offered by BIBP-CorV (Sinopharm), Covaxin (Bharat Biotech), Sputnik V (Gamaleya Institute), and Convidecia (CanSino). These vaccines could be recognised in the coming weeks or months as more data becomes available.

All four COVID-19 vaccines which have been granted provisional approval in Australia - from Pfizer (Comirnaty), AstraZeneca (Vaxzevria), Moderna (Spikevax) and COVID-19 Vaccine Janssen are also recognised for incoming travellers.

The TGA will continue work on vaccine recognition for the next couple of years and in the coming weeks and months we expect to receive more data not only on the vaccines listed above, but on a wide range of other vaccines already in use or in late-stage clinical trials in other countries. Our decisions around recognition will therefore be updated at regular intervals.

The TGA has undertaken this work at the request of government and this work will help inform decisions that will subsequently be made by Government to support incoming travel to Australia in the coming months.

The TGA will continue to interact with international regulators, monitor the medical literature and update its advice when sufficient information becomes available that demonstrates particular vaccines provide sufficient levels of protection.

TGA's assessment report can be found at COVID-19 vaccines not registered in Australia but in current international use - TGA advice on "recognition".