New Delhi: A key meeting between Bharat Biotech's MD Dr V Krishna Mohan, other officials of the Hyderabad based pharma major and senior officials of the Ministry of External Affairs, Ministry of Health, Department of Biotechnology took place on Monday (May 24) as India pushes for early approval of Covaxin by the World Health Organization (WHO).
Bharat Biotech submitted an application to the WHO for Emergency Use Listing (EUL) on April 19. A pre-submission meeting will take place in June.
The officials aware of the development said that the company has "submitted 90% of the documentation required for EUL to WHO" with the remaining to be submitted next month.
They further explained that the company is "confident about obtaining EUL given its experience of getting its other vaccines prequalified by WHO".
So far, COVID vaccines globally have been given approval by WHO for EUL including Pfizer, AstraZeneca, Janssen, Moderna and Sinopharm.
Covaxin is the first Indian COVID vaccine and is based on inactivated virus produced in cell culture or vero cell platform. So far it has received regulatory approval from 11 countries and 11 companies in seven countries have shown interest in technology transfer and production of Covaxin.
The company is in the final stages of submission of required documents regulatory approvals for its vaccines in Brazil and Hungary. With the US, Bharat Biotech is in "final stages of negotiations" with Food and Drug Administration (FDA) conducting small-scale Phase-III clinical trials locally.
The officials said, “the company is 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."
The regulatory approvals have both retrospective and prospective effect, and it stands out being few companies that have published papers on four COVID virus variants.
The company plans to produce 1 billion vaccines via its three different facilities in three different states - from Hyderabad facility 200-250 million, Bangalore around 500 million doses and Ankleshwar, Gujarat to the tune of 200 million.