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Australia recognises Covaxin, which is not approved by WHO yet

Photo by ÀniL from Pexels
Photo by ÀniL from Pexels

The Therapeutic Goods Administration (TGA) has determined that India’s Covaxin will be ‘recognised’ to establish a traveller’s vaccination status.

Australia’s regulatory authority for therapeutic goods, the TGA, announced on Monday that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be ‘recognised’ to establish a traveller’s vaccination status.

“This recognition is for travellers aged 12 and over who have been vaccinated with Covaxin, and those 18 to 60 who have been vaccinated with BBIBP-CorV,” it said in a statement.

The TGA says, in recent weeks, it has obtained “additional information demonstrating these vaccines provide protection and potentially reduce the likelihood that an incoming traveller would transmit COVID-19 infection to others while in Australia or become acutely unwell due to COVID-19.”

“The supporting information has been provided to the TGA from the vaccine sponsor and/or the World Health Organisation.”

It is to be noted that the World Health Organisation has not yet approved Covaxine, saying additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine.

WHO’s technical advisory group will meet on 3 November to conduct a final risk-benefit assessment for Emergency Use Listing (EUL) of Covaxin.

“The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure,” a WHO report said.

Indian Prime Minister Narendra Modi had said at the G-20 summit in Rome that the WHO approval for the emergency use authorisation for Covaxin, India’s indigenous vaccine, is pending. He suggested that a nod for the jab will help India assist other countries in vaccinating their population sooner than later.

Mauritius, Oman, the Philippines, Nepal, Mexico, Iran, Greece, Estonia and Zimbabwe have already recognised Covaxine.

The TGA said recognition of Covaxin, and BBIBP-CorV, along with the previously announced recognition of Coronavac (manufactured by Sinovac, China) and Covishield (manufactured by AstraZeneca, India), means many citizens of China and India as well as other countries in our region where these vaccines have been widely deployed will now be considered fully vaccinated on entry to Australia.

“This will have significant impacts for the return of international students, and travel of skilled and unskilled workers to Australia,” it said.

From 1 November 2021, vaccinated Australians and permanent residents aged 12 and over are allowed to travel overseas and enter Australia without seeking a travel exemption.

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