Covaxin is one of three vaccines currently being used in India
Bharat Biotech, maker of the Covid-19 vaccine Covaxin, and the World Health Organization (WHO) on Wednesday held a ‘pre-submission’ meeting for the International Emergency Use List (EUL) of the drug. The aim of the meeting was to give the Hyderabad-based biotechnology company an opportunity to seek guidance from the world body before it is finalized for the vaccine. WHO had earlier accepted Expression of Interest (EoI) for Covaxin from Bharat Biotech.
According to WHO guidelines, EUL is a process to streamline the process by which new or unlicensed products can be used during public health emergencies. The company has already submitted 90 per cent of the documents to WHO for obtaining EUL for Covaxin.
According to WHO, it grants EUL to new or unlicensed products as a risk-based procedure to be used during public health emergencies. So far seven vaccines have been given EUL. This includes Covishield, Pfizer, Moderna, and others.
WHO Norms for EUL Grants: Indicators
- To obtain an EUL, Covaxin must demonstrate a reasonable likelihood of quality, safety, and effectiveness.
- The disease for which the product is intended is serious or immediately life-threatening, causing outbreaks, epidemics or epidemics and for which there is no licensed product for indication or for a significant sub-population (eg children) is.
- The product is manufactured under a functional quality management system
- The assessment will determine whether, in the light of available WHO/international standards, the presented data demonstrate a reasonable likelihood that the quality, safety and performance of the IVD is acceptable and that the benefits outweigh the potential risks and uncertainties in the context of PHEIC.
- The validity of the EUL will be maximum for one year.
The Covaxin manufacturer has also submitted data for phase III clinical trials to the Drug Controller General of India (DCGI). The vaccine, developed in collaboration with the Indian Council of Medical Research (ICMR), is one of the three vaccines currently being used in the country.
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