Bharat Biotech Applies for WHO Emergency-Use Listing, Pre-Submission Meeting Soon
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Hyderabad: Hyderabad-based Bharat Biotech has applied to the World Health Organization for Emergency Use Listing (EUL). As per reports, the Indian company had submitted its Expression of Interest (EOI) on the 19th of April and is awaiting a pre-submission meeting to be held in May-June 2021, as per key WHO documents. Following the pre-submission meeting, it will be required to go through 2 more stages, the acceptance of the dossier for review and the final status of assessment before its application is accepted. On February 15, WHO gave emergency use approval to the Covishield vaccine produced by the Serum Institute of India. So far, seven vaccines globally have been approved by WHO for EUL which are Pfizer’s Community, AstraZeneca’s AZD1222, Janssen’s Ad26.COV2.S, Moderna’s mRNA-1273, and Sinopharm’s SARS-CoV-2 Vaccine. Meanwhile, Russia’s Sputnik, China’s Sinovac, and Cuba have also applied for emergency approval. As per data available, less than 10 nations have officially approved the Covaxin. Most countries only recognize Oxford-AstraZeneca’s Covishield as the required vaccine for passengers coming from India, reported Moneycontrol. Speaking with Wion, Joint managing director of Bharat Biotech, Suchitra Ella said their vaccine, COVAXIN has been proved to be neutralizing all these variants including the double mutant, which has been observed in India & has an edge given it is inactivated virus produced in cell culture or Vero cell platform. Attaining the emergency approval by WHO will bring with it many benefits, it will allow Covaxin to get global approval for the use which will, in turn, facilitate easy movement of Indians who have been vaccinated by it.
In the future, the company plans to produce one billion vaccines via its three different facilities in three states, 200-250 million from Hyderabad facility, around 500 million doses from Bangalore, and 200 million from Ankleshwar, Gujarat.WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.