New Delhi: Bharat Biotech’s Covaxin is likely to get pre-qualification approval from WHO by August with the company informing the government that it is currently in the process of submitting documents, particularly regarding validation of one of its manufacturing facilities.
The firm is also submitting documents for completion of Phase 3 trials for Covaxin to WHO, which will be done by the third week of June.
On Monday, foreign secretary Harsh Shringla, along with senior officials from the health ministry and the department of biotechnology met V Krishna Mohan and Sai Prasad of Bharat Biotech to discuss the progress on emergency use listing (EUL) for WHO. The company started the process with WHO in April with an ‘expression of interest’. The EUL by the WHO, sources said, was 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.
Bharat Biotech is also hoping for approvals from Brazil and Hungary for Covaxin in the coming weeks, sources said, with final documents submitted. The company, which developed an indigenous Covid-19 vaccine with ICMR, is also in the final stages of negotiations with the US FDA to conduct small Phase 3 trial in the US. An FDA approval will go far in increasing global acceptability for Covaxin.
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 on Sunday that Shringla was likely to meet BBIL officials to expedite the process of WHO approval for Covaxin, which has been administered to almost 2 crore people till now.
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 antibody 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,” a source said.
Covaxin has received regulatory approval from 11 countries. “There was also interest from other 11 companies in seven countries for technology transfer and production of Covaxin,” the source said.
The government 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,” an official said.