Bharat Biotech informed that it has submitted all documents to the World Health Organisation (WHO) for Emergency Use Listing (EUL) of its Covid-19 vaccine Covaxin and the review process has started off.
Bharat Biotech Chairman and Managing Director Krishna Ella informed that all documents required for EUL of Covaxin have been submitted to WHO as of July 9. The review process has already started off with the expectation that they will receive EUL from WHO at the earliest.
According to the reports, in May, Bharat Biotech stated that the application for EUL was submitted to WHO-Geneva and regulatory approvals are expected by July-September 2021. On June 30, the vaccine maker announced that it is working closely with the WHO for the inclusion of Covaxin in its EUL.
The official statement informed that the approval from WHO is not expected to be a long-drawn process as the cell line and majority of their facilities have already been audited and approved by WHO for their other vaccines in the past. It also stated that they are a step closer to the final decision on Covaxin’s global acceptance as the rolling data is slated to begin in July 2021.
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