Bharat Biotech's pre-submission meeting for Covaxin's WHO approval on June 23
New Delhi, June 17: Hyderabad-based Bharat Biotech's pre-submission meeting for evaluation of WHO's Emergency Use Listing (EUL) of its Covid-19 vaccine COVAXIN has been scheduled for June 23.
Covaxin is not yet on the World Health Organisation's (WHO) Emergency Use Listing (EUL) as well. The latest WHO guidance document shows that Bharat Biotech has submitted its Expression of Interest (EoI) but "more information is required".
Bharat Biotech has submitted 90% of the documents to WHO for obtaining the EUL for Covaxin. The remaining documents are expected to be submitted to WHO in June, news agency PTI quoted sources as saying.
Covaxin is among the three coronavirus vaccines currently being administered in the country. India's homegrown vaccine was granted restricted emergency use approval in 'clinical trial mode' on 2 January.
Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotechs BSL-3 (Bio-Safety Level 3) bio-containment facility.