Bharat Biotech's Pre-Submission Meeting For COVAXIN's WHO Approval On June 23
The Hyderabad-based Bharat Biotech is the 2nd made-in-India vaccine to apply at the global body for Emergency Use Listing (EUL)
Bringing the Indian Covid vaccine a step closer to World Health Organisation's approval, the pre-submission meeting will be taking place on June 23. WHO documents show, the Expression of Interest (EOI) has been accepted by the Geneva headquartered body.
Bharat Biotech, the company that manufactures the vaccine had submitted its Expression of Interest (EOI) on April 19. Once the Dossier is accepted for review, and the status of assessment finalized, a decision is expected.
The Hyderabad-based Bharat Biotech is the 2nd made-in-India vaccine to apply at the global body for Emergency Use Listing (EUL). The Serum Institute of India Manufactured COVISHIELD got WHO EUL on 15th Feb 2021. A benefit of WHO listing will allow COVAXIN to get global approval for use, something that has other benefits like the easy movement of Indians who have been vaccinated by it.
May saw an important meeting of Bharat Biotech officials and senior officers of the Ministry of Health, Department of Biotechnology, and Ministry of External Affairs to chalk out a strategy for early approval of the vaccine. COVAXIN has received emergency use authorization from 14 countries with more than 50 countries in the process. When it comes to the US, Bharat Biotech's US Partner Ocugen has been asked by FDA to pursue Biologics License Applications (BLA) path for COVAXIN's full approval.
So far 8 vaccines globally have been approved by WHO for EUL, these are COVID vaccines by Pfizer, AstraZeneca, Janssen, Moderna, Sinovac & Sinopharm. Russia's Sputnik vaccine is expected to get approval soon "once all the data is submitted", said WHO documents. A total of 22 vaccines have applied for WHO approval globally, with 14 in various stages of negotiation.
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