As Covaxin gets nod from Australia's health regulatory body; read all details of approval

In another significant feat for India, Australia has become the newest country to recognise India-made Bharat Biotech’s COVID-19 Covaxin. In an official statement on Monday, 1 November, Australia’s Therapeutic Goods Administration (TGA) that India’s indigenously produced Covaxin would be “recognised” for establishing the COVID-19 vaccination status of the travellers. This implies that people above the age of 12, inoculated with Covaxin are now allowed to enter Australia. 

In the official release, the Therapeutic Goods Administration, the medicine and therapeutic regulatory agency of the Australian Government, stated that in recent weeks it obtained additional information about Covaxin providing protection and potentially reducing the chances that an incoming traveller would transmit the disease to others while being in Australia or become severely ill. Australia’s TGA said that it received information from the vaccine sponsor and/or the World Health Organization (WHO). 

The United Nations (UN) health agency has separately shown confidence in India’s COVID-19 vaccine but is yet to provide a green light for its Emergency Use Listing (EUL). Apart from Covaxin, the TGA also recognised China-made COVID-19 vaccine, Sinopharm for people above the age of 18 for determining the traveller’s vaccination status.

What is TGA? 

Australia’s Therapeutic Goods Administration (TGA) is the country’s regulatory authority for therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. It is mainly responsible for a range of assessments. It also monitors activities to ensure therapeutic goods available in the country are of an “acceptable standard” with the goal to ensure that the community in the island nation has access to therapeutic advances within a reasonable time. Hence, TGA also deals with the approval of COVID-19 vaccines in the country amid the pandemic. 

As explained on the official website, TGA said, “We will only register a vaccine if its benefits are much greater than its risks.” 

What does TGA's approval mean for Covaxin?

Covaxin being “recognised” by TGA implies that India-made vaccine was subjected to a lengthy process of at least six stages including pre-application, application, evaluation, decision, registration and monitoring. Once approved by the TGA, the vaccine is included in the Australian Register of Therapeutic Goods (ARTG) as a provisionally registered medicine and can be lawfully supplied in Australia by the sponsor.

"Approved vaccines will appear in the searchable ARTG on the TGA website. Product Information and Consumer Medicines Information will also be available in the MedSearch App in the same way as for any other registered medicine," explained TGA in its COVID-19 vaccine approval process.

“The provisional registration is for an initial period of two years, with the option to apply for up to two extensions, up to a maximum of six years,” it added. 

Australia’s TGA’s approval for Covaxin also means that travellers above the age of 12, inoculated with an India-made vaccine will be allowed to enter the country. The TGA said, “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.”

(IMAGE: PTI/AP)