COVID-19: Bharat Biotech's pre-submission meeting for Covaxin's WHO approval on June 23
Covaxin
Bringing the Indian Covid vaccine Covaxina step closer to World Health Organization's approval, the pre-submission meeting will be taking place onJune 23. WHO documents show the Expression of Interest (EOI) has been accepted by the Geneva-based body.
Hyderabad-basedBharat Biotech, which 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 finalised, a decision will be taken.
Covaxinis the second made-in-India vaccine to apply at the global body for Emergency Use Listing (EUL). Covishield, made by the Serum Institute of India, got WHO EUL on 15th February.
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 authorisation from 14 countries, with more than 50 other countries in the pipeline. 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.
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So far, eight vaccines globally have been approved by WHO for EUL, including those made by Pfizer, AstraZeneca, Janssen, Moderna, Sinovac and 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 negotiations.