Home >News >India >Bharat Biotech submits 90% documentation to WHO for EUL of Covaxin

Bharat Biotech International Limited (BBIL) which manufactures India’s homegrown covid-19 Covaxin vaccine has submitted 90% of the documentation needed for the World Health Organisation (WHO)’s Emergency Use Listing.

The Emergency Use Listing (EUL) will open the doors for the Indian developed Covaxin to be accepted and used by other countries.

Besides the WHO, BBIL has also submitted documents for Covaxin’s regulatory approvals in Brazil and Hungary and the company is also in the final stages of negotiations with the US Food and Drug Administration or FDA for conducting small-scale Phase-III clinical trials in the US, two people familiar with the matter said.

These issues came up for discussions at a meeting among BBIL representatives and officials of Ministry of Health, Department of Biotechnology and Ministry of External Affairs, the person cited above said. The BBIL team was headed by Dr. V. Krishna Mohan, managing director of the Hyderabad based company. It comes ahead of Indian diplomats and company representatives pushing for clearances for Covaxin with international agencies.

The meeting was called in the context of news reports that countries may seek to institute a “vaccine passport" ie requiring documentation from travelers that they have been inoculated with an internationally recognized anti-covid-19 vaccine. The vaccines that are in popular use across the world include those manufactured by Pfizer and Moderna. Some vaccines manufactured by China and Russia’s Sputnik vaccine are also in use in some countries.

“It is important to note that no country has instituted a vaccine passport. Countries have their own requirements for approval, which in most cases involves travel by carrying a negative RT-PCR report," the person cited above said.

“On the issue of WHO’s authorization for Emergency Use Listing (EUL), BBIL noted that they had submitted 90% of the documentation required for EUL to WHO," the person said.

BBIL conveyed that the remaining documents were expected to be submitted in June 2021. “BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines pre-qualified by WHO," the person cited above said.

Covaxin has already received regulatory approval from 11 countries with another 11 companies in 7 countries showing interest for technology transfer and production of Covaxin, a second person aware of the developments said. Some of the countries that have approved Covaxin include Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay, Zimbabwe and India.

“BBIL is in regular touch with regulatory authorities in the above-mentioned countries. They are confident about the robustness of their dossier, as they have data for much longer duration – for anti-body persistence after 6 months as well as 8 months. It is one of the few companies that have published papers on all four Covid virus variants," the second person said.

India has sent both Covishield and Covaxin as part of its “Vaccine Maitri" programme. According to clinical trials conducted by Bharat Biotech, Covaxin has an 81% efficacy in dealing with the coronavirus and its mutant strains.

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