Indigenous vaccine producer Bharat Biotech on Monday ( July 12) said that it has submitted all the necessary documents to the World Health Organisation (WHO) for Emergency Use Listing (EUL) of its Covid-19 vaccine Covaxin.
According to Bharat Biotech Chairman and Managing Director Krishna Ella, the review process has commenced and all documents required for EUL of Covaxin have been submitted to WHO as of 9 July.
COVAXIN® EUL pic.twitter.com/dCilH7KbSk
— BharatBiotech (@BharatBiotech) July 12, 2021
“The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest,” he said.
Bharat Biotech had made the announcement in May that that application for EUL was submitted to WHO and regulatory approvals are expected by July-September 2021 and it is working closely with the WHO for 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 indigenous vaccine has 63.6 per cent efficacy against the Delta variant of Covid-19, which has now spread to many other countries and Covaxin demonstrated 93.4 per cent efficacy against severe symptomatic Covid-19 and 63.6 per cent against asymptomatic Covid-19.
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