Bharat Biotech applies for WHO nod for Covaxin; pre-submission meeting soon

Hyderabad-based Bharat Biotech has summitted application to the World Health Organization for Emergency Use Listing (EUL) of its Covid vaccine Covaxin, becoming the second India-made vaccine to apply at the global body for authorisation.

Bharat Biotech had summitted its Expression of Interest (EOI) on April 19, with more information required according to documents on WHO website.  

It will have to now go through three more stages, pre-submission meeting, dossier accepted for review and final status of assessment. The pre-submission meeting will take place later in May or June.   

Last week, speaking to WION exclusively, Suchitra Ella, joint managing director, Bharat Biotech, said, the Covaxin "proved to be neutralising all variants including double mutant, which has been observed in India" and it has an 'edge' given it is inactivated virus vaccines produced in cell culture or vero cell platform. 

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. 

A benefit of WHO listing will allow Covaxin to get global approval for use, something that has other benefits like easy movement of Indians, who have been vaccinated by it. While when it comes to mutual recognition of vaccines by countries is still under progress, if and when it comes into effect, WHO approved vaccines will give an automatic benefit.  

On February 15, WHO gave emergency use approval to Covishield vaccine produced by Serum Institute of India. So far, seven vaccines globally have been given approval by WHO for EUL, these are Pfizer's Comirnaty, Astrazeneca's AZD1222, Janssen's Ad26.COV2.S, Moderna's mRNA-1273 and Sinopharm's SARS-CoV-2 Vaccine. Russia's Sputnik, China's Sinovac and Cuba have also applied for emergency approval.