Hyderabad (Telangana): The World Health Organization has accepted the Expression of Interest (EOI) proposal for the emergency use listing of 'Covaxin' and a meeting in this regard is being held today. According to the World Health Organization (WHO), the product will not be reviewed in detail at this meeting, but the vaccine manufacturer will have an opportunity to present a brief description of the quality of the vaccine. In May, Bharat Biotech had expressed confidence that it would get approval from the WHO by July-September for the emergency use of its vaccine. According to WHO guidelines, Emergency Use Listing (EUL) is the process by which new or unlicensed products are approved for use in times of public health crisis.
According to WHO, an opportunity for advice and consultation is given prior to the handover of a detailed report and the applicant also gets the opportunity to meet WHO's assessors who would review the vaccine. Also, sources had earlier indicated that Bharat Biotech International Limited (BBIL) had informed the Centre that it has submitted 90 per cent of the documents to WHO to obtain EUL for the vaccine. Last month, the vaccine maker had informed the central government that the rest of the documents were likely to be handed over by June.
Read: Bharat Biotech's Covaxin shows 77.8 pc efficacy in Phase III trials, say sources
It is known that Bharat Biotech's Covaxin has shown 77.8 per cent efficacy after the Subject Expert Committee (SEC) under the drug regulator reviewed its Phase III trials data on Tuesday, according to sources. The Hyderabad-based COVID vaccine manufacturing company had submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI).
