India / WHO approval for Covaxin expected by July-Sept 2021: Bharat Biotech

NEW DELHI: Bharat Biotech is likely to get a pre-qualification approval from WHO by August.

The company has informed the government that it is currently in the process of submitting documents, particularly regarding validation of one of its manufacturing facilities. It is also submitting the documents for completion of Phase 3 trials for Covaxin to the WHO, which will be completed by the third week of June.

On Monday, foreign secretary, Harsh Shringla, along with senior officials from ministry of health and department of biotechnology met V Krishna Mohan and Sai Prasad of Bharat Biotech to discuss the progress on the EUL for WHO.

BBIL started the process with WHO in April with an “expression of interest”.

The EUL by the WHO, sources said, is likely to come through after a 60-day review of documents provided by the company, which could include a physical audit of BBIL’s units.

In a meeting with MEA and health ministry officials, BBIL expressed confidence about obtaining approval, given its experience of getting its other vaccines pre-qualified by WHO, official sources said.

TOI had first reported Sunday that foreign secretary Harsh Shringla was likely to meet BBIL officials Monday to expedite the process of WHO approval for Covaxin, which has been administered to almost 2 crore people until now.

Bharat Biotech is hoping for approvals from Brazil and Hungary for Covaxin in the coming weeks, sources said, after final documents have been submitted to both countries. The company, which has developed an indigenous Covid vaccine, is also in the final stages of negotiations with FDA in the US to conduct small phase 3 trials for Covaxin in the US. An FDA approval will go far in increasing global acceptability for Covaxin. A pre-qualification approval for Covaxin by WHO is expected in August.

In the meeting with government officials, BBIL executives said regulatory approvals would all have retrospective effect. "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," said the source.

Covaxin has received regulatory approval from 11 countries. "There was also interest from other 11 companies in 7 countries for technology transfer and production of Covaxin," said a government source.

The government further said no country had instituted a vaccine passport. "Countries have their own requirements for approval, which in most cases involves travel by carrying a negative RT-PCR report," said an official.