NEW DELHI: A panel of experts of the World Health Organisation (WHO) will meet on Tuesday to decide on the issue of granting the Emergency Use Listing (EUL) authorisation to Bharat Biotech’s COVID-19 vaccine Covaxin.
The Hyderabad-based vaccine maker has already provided all documents required by the global health body after it reportedly granting the EUL nod to Covaxin over some technical queries.
Documents detailing the WHO expert committee’s agenda for the meeting show that it will discuss the assessment status of pending applications for vaccine candidates, including Covaxin.
Top health experts are of the view that Covaxin’s approval shouldn’t be delayed after reviewing the data this month.
It was earlier reported that WHO’s emergency use authorisation for Covaxin will most likely come in October month.
The Hyderabad-based vaccine manufacturer had 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.
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.