WHO's emergency use nod for Covaxin most likely in October

NEW DELHI: World Health Organisation’s (WHO) emergency use authorisation (EUA) for Bharat Biotech-developed Covaxin is most likely to come in October month, said reports on Thursday.

According to reports, the Hyderabad-based vaccine manufacturer has submitted all documents required by the global health agency and said that it is 'working diligently with the WHO to obtain EUL at the earliest.'

The EUA is important because without it Covaxin will not be accepted by most countries. WHO’s Strategic Advisory Group of Expert on Immunization (SAGE) is set to meet on October 5 to take a call on EUA to Covaxin.  

It was earlier reported that the World Health Organization has further delayed the emergency use authorisation for Covaxin over some technical queries.  Media reports said quoting sources that the global health watchdog has sent more technical queries to its manufacturer Bharat Biotech.

All this came days after Bharat Biotech claimed that it has submitted all data required for clearance of Covaxin. Bharat Biotech, in a statement, said that it is not appropriate to speculate or comment on the regulatory approval process and at an appropriate time it will announce the regulatory approval. It further stated that all the relevant trial data has been submitted to WHO, and all clarifications by the UN health agency have been responded to.

"We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines," the Hyderabad-based company said in a statement.

Dr VK Paul, Member (Health), Niti Aayog had earlier indicated in a press briefing that the WHO's EUA is expected in the last week of September. According to Bharat Biotech Phase 3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent.

The WHO has already approved COVID-19 vaccines by Pfizer -BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.