HYDERABAD, 26 May 2021, (TON): Bharat Biotech has confirmed that it has submitted application for Emegency Use Listing (EUL) of its coronavirus vaccine Covaxin before the World Health Organisation. The Indian vaccine manufacturer requested the global health agency to grant the approval but WHO asked the Indian manufatturer to furnish further information. Now the approval stand delayed till September quarted this year.
WHO’s EUL authorisation is a pre-requisite for COVAX facility, which is meant to ensure COVID-19 vaccine supply to poorer nations. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
A guidance document updated last week on WHO’s official website showed that Bharat Biotech submitted expression of interest for EUL on 19 April 2021. However, the request was not granted as the health agency wanted some more details from the company.
Covaxin is the first coronavirus vaccine to be completely developed in India. Bharat Biotech formulated the jab based on the SARS-CoV-2 strain isolated by the National Institute of Virology (NIV), Pune. The company has deployed three facilities – in Hyderabad, Bengaluru and Ankleshwar – to manufacture the vaccine. It is in the process of scaling up production capacity to 1 billion doses per annum.
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