Ahead of WHO-Bharat Biotech meet on Covaxin, key stakeholders come together

A key meeting between Bharat Biotech's Executive Director Dr V Krishna Mohan and 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 as India pushed for early approval of Covaxin by the World Health Organization (WHO).

Other officials of the Hyderabad-based pharma major were present for the meet as well.

Bharat Biotech has sent an application to the WHO for Emergency Use Listing (EUL) of Covaxin on 19th April and a pre-submission meeting will take place in June.

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 WHO EUL subsequently, given its experience of getting its other vaccines prequalified by WHO."

Bharat Biotech's Covaxin will be the second made-in-India vaccine after Covishield to apply to WHO for approval.

Covishield has already got approval in February. So far, seven vaccines globally have been given approval by WHO for EUL, these are Covid vaccines from Pfizer, AstraZeneca, Janssen, Moderna and Sinopharm.

Covaxin is the first Indian Covid vaccine and is based on inactivated virus vaccines 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 the technology transfer and production of Covaxin.

The company is in the final stages of submission of documents required for regulatory approvals for its vaccines in Brazil and Hungary.

In the US, Bharat Biotech is in the "final stages of negotiations" with Food and Drug Administration (FDA) for conducting small-scale Phase-III clinical trials locally.

Officials said, "The company is confident about the robustness of their dossier, as they have data for a much longer duration – for antibody persistence after six months as well as eight months."

The regulatory approvals have both retrospective and prospective effect, and it stands out being few companies that have published papers on all four Covid virus variants.  

The company plans to produce 1 billion vaccines via its three facilities in three Indian states.

Hyderabad facility in Telangana will produce 200-250 million vaccines, Bengaluru facility in Karnataka will produce around 500 mn doses and facility in Ankleshwar, Gujarat will produce about 200 mn vaccines.