WHO’s emergency-use licence

Subject – Science and Tech

Context – There is a great amount of speculation as to whether the WHO will give its Emergency Use Licence approval for Covaxin.

Concept –

Organisations can apply for WHO’s EUL based on the availability of clinical trial data to demonstrate safety, efficacy and manufacturing of the products, in compliance with Good Manufacturing Practices (GMP) and under a functional Quality Management System.
As part of the process, a Common Technical Document containing tens of thousands of pages of data and information will have to be submitted to the WHO, with data from clinical trials, commercial scale manufacturing, quality control and quality assurance.
This vast amount of data and information is reviewed by a galaxy of global experts, followed by queries, samples testing and site audits as required.
As of now, the vaccines of six pharma companies have received EUL – Moderna, Pfizer, Janssen, AstraZeneca, Sinovac and Sinopharm. Several others, including Covaxin, are in process.
Every country has its own independent criteria for international travel. Many countries could use the WHO EUL as a benchmark for international travel, while other countries could establish their own.

To know about Emergency Use Listing, please click here.