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Much interest, and anxiety, has been generated by the high-decibel discussions on the “emergency use listing” (EUL) of Covid-19 vaccines by the World Health Organization and why it is required in some countries. As Bharat Biotech’s Covaxin vaccine undertakes the regulatory process to get this emergency tag, here’s a look at what it means, especially since over 11 crore people have taken it already in India.
What is a EUL?
The procedure is a risk-based one to assess and list vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. It gains significance in countries that do not have an elaborate regulatory mechanism, in which case they can rely on the WHO endorsement.
International travel in many countries presently requires people to get a vaccine on the WHO’s approved list.
What is the EUL process?
It is a complex one that takes about 12-24 months, generally after submitting a dossier by a vaccine maker. However, in pandemic times, the review process has been faster to meet global requirements. The application and data submitted are reviewed by two groups - the Strategic Advisory Group of Experts on Immunisation (SAGE) and Technical Advisory Group (TAG), an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.
What are the Covid-19 vaccines that have a EUL?
As of now, WHO has six vaccines on the approved list. They are from Pfizer-BioNTech, Moderna Janssen (Johnson & Johnson), Oxford/AstraZeneca, including Serum Institute of India’s Covishield (AstraZeneca’s formulation), Sinopharm and Sinovac.
Is EUL a must for exports?
No. There is no link between EUL and exports. A vaccine maker can export its vaccines subject to the approval of the importing country’s health regulator. However, EUL can augment demand for a particular vaccine as it facilitates easier international travel for people. And EUL is essential if the company wants to supply to the WHO-supported Covax facility that distributes in low and middle-income countries.
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