Australia drugs regulator approves Covishield for incoming travelers

Australia's top medical regulator on Friday approved the Covishield vaccine manufactured by the Serum Institute of India for incoming international travellers, a step that is expected to facilitate the return of thousands of Indian students to that country.

Australian Prime Minister Scott Morrison's office said the Therapeutic Goods Administration (TGA) has advised that Coronavac (Sinovac) and Covishield should be considered as "recognised vaccines" for the purpose of determining incoming international travellers as being appropriately vaccinated.

It said Australia is ready to take its next steps to safely reopen to the world, with changes coming to the international border.

"Our government is setting out the framework for how international travel will look in coming months," it said.

It is not immediately clear whether the TGA's approval for Covishield will facilitate immediate travel to Australia by Indian students waiting to return to that country or whether certain changes will have to be made to the existing protocols for the entry of foreign nationals into the country.

The TGA is Australia's medicines and medical devices regulator.

"Today, the TGA has published its initial assessment of the data on the protection offered by the Coronavac (Sinovac) and Covishield (AstraZeneca/Serum Institute of India) vaccines and has advised that these vaccines should be considered as 'recognised vaccines' for the purpose of determining incoming international travellers as being appropriately vaccinated," the Australian Prime Minister's Office (PMO)said in a statement.

It said declaring certain COVID-19 vaccines as 'recognised vaccines' is separate to a regulatory decision on whether they are approved for use for vaccination in Australia, which has not been made by the TGA.

"The recognition of these two additional vaccines is a major milestone towards more Australians vaccinated overseas getting home sooner," the statement said.

"In coming weeks, the Minister for Health will consider updates to the Biosecurity Act Emergency determinations to facilitate some of these changes for fully vaccinated Australian travellers as we move forward on the National Plan to get Australia back to normal and reopen our country safely," it said.

The Australian PMO said that the government will finalise in the coming weeks the processes for people to be able to show their vaccination status if they have had a TGA recognised vaccine.

"People who have received vaccines not recognised by the TGA, or who are unvaccinated, will be required to undertake 14 days of managed quarantine on arrival," it said.
 

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