Bharat Biotech’s Covaxin recognized by Australia

The Australian regulatory authority for therapeutic goods ‘Therapeutic Goods Administration’ (TGA), Department of Health released a notice recognising Covaxin for the purpose of establishing a traveller’s vaccination status.

In a significant boost to vaccine research and manufacturing capabilities of pharmaceutical companies in Hyderabad, the Australian government on Monday recognised Covaxin, the Covid vaccine manufactured by city-based Bharat Biotech, for people travelling to Australia.

The Australian regulatory authority for therapeutic goods ‘Therapeutic Goods Administration’ (TGA), Department of Health, released a notice recognising Covaxin for the purpose of establishing traveller’s vaccination status.

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“This recognition is for travellers aged 12 and above who have been vaccinated with Covaxin,” the TGA said.

Meanwhile, Ministry of External Affairs (MEA) said that five more countries have recognised India’s vaccination certificate, including Estonia, Kyrgyzstan, State of Palestine, Mauritius and Mongolia.

In a tweet, MEA spokesperson Arindam Bagchi said, “Mutual recognition of Covid-19 vaccination certificates continues! Five more recognitions for India’s vaccination certificate, including from Estonia, Kyrgyzstan, State of Palestine, Mauritius and Mongolia.” These five countries recognised both Covaxin and Covishield.

The nod for Covaxin from Australian authorities could also pave the way for Covaxin to receive Emergency Use Authorisation (EUA) from World Health Organization (WHO), which is pending for the past few months. According to reports, the technical advisory group of WHO is expected to meet on November 3 to conduct the final risk-benefit assessment for emergency use listing of Covaxin.

The Australian regulatory authorities, who had imposed stringent strategies across the country to contain the spread of Covid-19 infections, said that in the last few weeks the TGA had obtained additional information from manufactures (Bharat Biotech) and even World Health Organisation (WHO), which had demonstrated that 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 recognition for Covaxin and previously announced recognition to Covishield, which is being manufactured by Serum Institute of India (SII), Pune, means that ‘many citizens from India as well as other countries where these vaccines have been widely deployed will now be considered fully vaccinated on entry to Australia. This will have significant impact for the return of international students, and travel of skilled and unskilled workers to Australia, the TGA said.

Those who have received two doses of TGA-approved vaccine at least 14 days apart will be regarded as fully vaccinated from 7 days after the second dose. Apart from Covaxin, the TGA of Australian government has also approved BBIBP-CorV vaccines, which is manufactured by Sinopharm, China on Monday. The Covid vaccine from China has received nod for those between 18 years and 60 years while Covaxin has received permission for any traveller aged 12 years and above.

So far, the WHO has approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna and Sinopharm for emergency use.

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