Australia’s Therapeutic Goods Administration (TGA) has undertaken an assessment on the protection offered by certain Covid-19 vaccines that are administered in other 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, the TGA highlighted.
In the report it 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. These are countries from which Australia normally receives many international arrivals.
‘Recognition’ is not local approval
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.
However, ‘recognition’ status does not constitute Australian regulatory approval, as this would enable a company to provide that vaccine for administration within Australia.
At this point, the TGA says it 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,” it noted in a media statement.
TGA will continue examining data
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,” the statement said.
“Our decisions around recognition will therefore be updated at regular intervals.”
The study was undertaken at the request of the Government to help inform decisions that will subsequently be made about allowing future travellers into Australia.
