Decision in a month and a half on inclusion of covacin in EU: WHO

New Delhi, 10 July 2021 Saturday

The World Health Organization (WHO) will take a decision in four to six weeks on the inclusion of India Biotech's Corona vaccine in the Emergency Use List (EUL).

Addressing a webinar organized by Saimya Swaminathan Center for Science and Environment (CSE), the chief scientist of the World Health Organization, he said that India Biotech, the manufacturer of covacin, is now uploading full details about it on the WHO portal.

According to WHO guidelines, the EU regulates the process by which a new or unlicensed product can be used in the event of a public health emergency. There is a follow-up process for Emergency Use List (EUL) and pre-qualification of the vaccine under which the company has to complete a three-stage trial and return all the details to the WHO regulatory department which is verified by an expert advisory group, Swaminathan said.

In addition to safety and quality, completeness of the details that are involved in the quality of the production time is required. I believe Bharat Biotech has already given the details. A decision on its inclusion in the EUL will be taken in four to six weeks, Swaminathan added.

The WHO has so far approved for immediate use vaccines manufactured by Pfizer Bioentech, AstraZeneca - SK Bio, Serum Institute of India AstraZeneca EU, Janssen, Moderna and Sinaform.

We currently have six EU-approved vaccines recommended by our Strategic Advisory Group of Experts (Sage). "We will continue to consider covacin for this recognition. The vaccine that our committee of experts will now review is India biotech manufactured covacin," said the chief scientist.

Saimya also provided information on a WHO research and development luprint prepared in 2016 shortly after the Ebola outbreak.