Bharat Biotech, the manufacturer of Covid-19 vaccine Covaxin, and the World Health Organisation (WHO) on Wednesday held a 'pre-submission' meeting for international Emergency Use Listing (EUL) of the drug. The objective of the meeting wa to give the Hyderabad-based biotechnology company a chance to receive guidance from the world body before the final submission for vaccine. The WHO had earlier accepted the Expression of Interest (EoI) for Covaxin from Bharat Biotech.
As per WHO guidelines, EUL is a procedure 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 documents to WHO for obtaining EUL for Covaxin.
According to WHO, it provides EUL to new or unlicensed products as a risk-based procedure to be used during public health emergencies. Seven vaccines have been granted EUL so far. This includes Covishield, Pfizer, Moderna and others.
WHO's criteria for EUL grant: Pointers
- To get EUL, the Covaxin has to demonstrate a reasonable likelihood of quality, safety and effectiveness.
- The disease for which the product is intended is serious or immediately life threatening, causing an outbreak, epidemic or pandemic and for which there is no licensed product for the indication or for a critical subpopulation (e.g. children)
- The product is manufactured under a functional quality management system
- Evaluation will determine whether, in light of available WHO/ international standards, the submitted data demonstrate a reasonable likelihood that the IVD's quality, safety and performance are acceptable and that the benefits outweigh the foreseeable risks and uncertainties in the context of a PHEIC.
- The validity of EUL will be maximum for an year.
The Covaxin maker has also submitted data for the Phase III clinical trials to Drugs Controller General of India (DCGI). The vaccine developed in association with the Indian Council of Medical Research (ICMR) is one one of the three vaccines which are currently being used in the country.