How does WHO approve Covid-19 vaccines for emergency use?
A day after Bharat Biotech announced 77.8 per cent efficacy for its Covaxin Covid-19 vaccine that's being used in India, the company is now set to meet World Health Organisation (WHO) officials to seek emergency use approval from the global body. The Emergency Use Listing (EUL) by the global health body will provide a platform for the company to supply the doses to several other countries. The listing is basically a license from the WHO to the company to make their vaccine available to people affected by a public health emergency. India has already been using Covaxin along with the Covisheild, which is manufactured by the Serum Institute of India, in its massive vaccination drive. The WHO EUL listing holds importance amid the continuous mutations of the virus, which has evolved from Delta to Delta Plus variant over the course of a month. While cases of the Delta variant have been found in 80 countries, Delta Plus patients have been found in nine countries -- USA, UK, Portugal, Switzerland, Japan, Poland, Nepal, China, Russia and India. Read on to find out. Covaxin has applied for EUL with WHO. (Photo: PTI)  MEETING THE ELIGIBILITY  The vaccine candidate should meet a set of parameters set by the WHO to get the EUL license. First, the disease for which the vaccine is intended should have the potential of causing an outbreak, epidemic or pandemic. ALSO READ | Coronavirus: Delta Plus is now a variant of concern in India  The product, for which the license is being sought, should be manufactured in compliance with current Good Manufacturing Practices (GMP) and under a functional Quality Management System. The applicants also have to undertake to complete the development of the product and apply for WHO prequalification once the product is licensed. EVALUATING THE DATA  The pharmaceutical company has to submit data related to the designing of the vaccine and from clinical trials conducted in different countries and on samples of different age groups. The WHO then evaluates the data in light of international standards checking if the submitted data demonstrate a reasonable likelihood that the vaccine quality, safety and effectiveness are acceptable. READ | Covaxin, Covishield effective against Delta variant of Covid-19: Centre  The health body also measures if the benefits offered by the vaccine outweigh any potential risks. The data sought by the WHO include details related to manufacturing quality, non-clinical and clinical trials, a plan to monitor quality, safety and efficacy. The companies also have to submit an undertaking to the organisation to provide any new data as soon as it is available along with details of labelling. Bharat Biotech had in March announced interim results of the Phase III trials. (Photo: PTI)  COVAXIN APPROVAL IN INDIA  Covaxin had received an emergency use nod from the government in January 2020 as India began its vaccination campaign. The approval was based on Phase I and II clinical trials. Then, the company was yet to provide details of Phase III clinical trials which is required before a vaccine is allowed to be used. WATCH | Explained: Why India should worry about the Delta variant  In March, Bharat Biotech announced interim results of the Phase III trials. It has now submitted its Phase III trial data to the Subject Expert Committee (SEC), which met on June 22 to review Bharat Biotechs findings. The expert committee will now send the data to the Drugs Controller General of India (DCGI) for further review.