Covaxin moves a step closer to WHO nod

Pre-submission meeting on Bharat Biotech’s EUL application slated for June 23

A WHO approval will come as a big boost for Covaxin and expected to pave the way for all those inoculated with it to travel to many countries.

India’s vaccine against COVID-19 Covaxin is set to get closer to World Health Organization (WHO) approval with a pre-submission meeting for its emergency use listing scheduled for June 23 by the organisation.

The meeting on the vaccine developed by Bharat Biotech is planned for June 23, a WHO document on the status of COVID-19 vaccines within EUL/PQ evaluation process and last updated on Thursday said.

Bharat Biotech, which in association with Indian Council for Medical Research (ICMR) has developed the whole-virion inactivated vaccine, last month said the WHO approval was expected in the July-September quarter. The WHO had then said the application was submitted in April 19 and more information was needed. A pre-submission meeting was scheduled in May-June, the U.N. agency had said.

A WHO approval will come as a big boost for Covaxin and expected to pave the way for all those inoculated with it to travel to many countries. “We are also looking forward to WHO’s approval for India’s indigenous vaccine manufactured by Bharat Biotech,” Foreign Secretary Harsh Vardhan Shringla had told WHO’s South-East Asia Regional Health Partners’ Forum on COVID-19 earlier this month.

Headway on EUL is important as the U.S. Food and Drug Administration had recently asked Bharat Biotech’s partner Ocugen to seek a Biologics Licence Application for the vaccine instead of pursuing an Emergency Use Authorisation. The U.S. regulator had sought additional information and data, which the firms said may trigger the need for an additional clinical trial and extend the timelines for getting the approval.

Covaxin is being used since January in India, following the Drugs Controller General of India according an emergency use authorisation. Bharat Biotech recently said more than 40 million doses of the vaccine had been supplied. The company said it would make the Phase III trials data from the final analysis public soon.

The vaccine had received emergency use authorisations in 13 countries and the process of seeking regulatory approvals was in process in over 60 countries, the company said.