Bharat Biotech on Monday said 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 commenced.
Bharat Biotech Chairman and Managing Director Krishna Ella said all documents required for EUL of Covaxin have been submitted to WHO as of July 9.
“The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest,” he said.
The Hyderabad-based company had said in May that that 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.
“Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” it had said.
“We are a step closer to the final decision on Covaxin’s global acceptance, as the rolling data is slated to begin in July 2021,” it added.
The company claims that with 10 scientific publications in 12 months, Covaxin is one of the very few vaccines to have extensive data published in globally renowned peer-reviewed journals.