Vaccine. Will WHO give emergency-use approval to Covaxin?

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

The Strategic Advisory Group of Experts on Immunisation (SAGE) of the WHO will review Covaxin data on October 5 (October 6 IST).

The vaccine, developed jointly by Hyderabad-based Bharat Biotech – in collaboration with Indian Council of Medical Research – has always hogged the limelight right from day one. Some doubts have been raised, without any substantiation, on the data submitted by the Hyderabad-based vaccine maker.

A fallout of the speculation is a growing concern among the general public who had taken the Covaxin shot and are travelling abroad. But then, is it wise to speculate on the matter?

Complex process

Answers to such questions can only be fathomed if one tries to understand the complex process involved in obtaining an EUL for a vaccine.

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.

Submission of data

Going by the process involved and updates available from the WHO, it may be noted that the submission of rolling data on Covaxin by Bharat Biotech, which commenced on July 23, is still on and a decision is expected this month.

“This clearly shows that the view that there has been a delay in decision is not appropriate. The process is on and, in fact, quite faster in view of the pandemic,” the Vice-President with a Hyderabad-based pharma company told BusinessLine , adding that Bharat Biotech had vast experience in dealing with the WHO.

Bharat Biotech has five WHO-prequalified vaccines, including Rotavac and Typbar TCV. Contrary to a view that Covaxin has no published data, there are 10 publications on Covaxin covering all phases of trials.

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.

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