While the World Health Organisation (WHO) has said that it requires “more information from Bharat Biotech to grant emergency use listing (EUL) for Covaxin, the Hyderabad-based company has claimed that it has already submitted about 90 per cent of documents required for EUL.
Further, the company informed the Centre that it would submit rest of the required documents by June and Bharat Biotech officials exuded confidence of receiving EUL for Covaxin, sources told PTI.
According to the WHO, it will most likely conduct a pre-submission meeting with Bharat Biotech between May-June.
The international body states that submissions to it for prequalification or listing under the emergency use procedure are confidential.
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If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely. Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.
Noting that Covaxin has already received regulatory approval from 11 countries, sources told PTI there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.
The company is in the final stages of negotiations with the Food and Drug Administration of the US for conducting small-scale phase-III clinical trials of Covaxin in the United States, sources said.
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Sources said the meeting with BBIL on the EUL was attended by the company's managing director V Krishna Mohan and his colleagues besides senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs.
Foreign Secretary Harsh Vardhan Shringla was among those who attended the meeting.
(With PTI inputs)
