Bharat Biotech is confident about obtaining the World Health Organization's (WHO) Emergency Use Listing for its COVID-19 vaccine given its experience of getting its other vaccines pre-qualified and has submitted 90 per cent of the documentation required for EUL by the global health body, sources said on Monday.
A meeting has been held with Bharat Biotech International Limited (BBIL) on the status of application for WHO's EUL for Covaxin, developed by the Hyderabad-based agency in collaboration with ICMR.
The attended was attended by Dr V Krishna Mohan, MD, Bharat Biotech International Ltd., and his colleagues with senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs (MEA), the sources said.
It was noted that Covaxin had already received regulatory approval from 11 countries, the sources said, adding there was also interest from other 11 companies in seven countries for technology transfer and its production.
The sources said BBIL noted that they had submitted 90 per cent of the documentation required for EUL to WHO and the remaining is expected to be submitted in June this year.
"BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines pre-qualified by WHO," a source said.
The company, the sources said, is in the final stages of submission of required documents for Covaxin's regulatory approvals in Brazil and Hungary and have also held extensive bilateral consultations with both countries.
They said the company is also in the final stages of negotiations with the Food and Drug Administration (FDA) of the USA for conducting small-scale Phase-III clinical trials in the United States.
They said BBIL clarified that all regulatory approvals have both retrospective and prospective effect.
The sources said BBIL is in regular touch with regulatory authorities in the above-mentioned countries and is confident about the robustness of their dossier, as they have data for much longer duration - for anti-body persistence after six months as well as eight months.
It is one of the few companies that have published papers on all four COVID virus variants, the sources added.
No country has instituted a vaccine passport and countries have their own requirements for approval, which in most cases involves travel by carrying a negative RT-PCR report.
( With inputs from ANI )
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