Eager for WHO approval for Covaxin: Suchitra Ella

The burning question across India is when would the World Health Organization (WHO) grant India’s indigenous Covid-19 vaccine, Covaxin, an EUL or Emergency Use Listing, thereby allowing countries to recognise the validity of the product. Now more so, as countries are opening up borders to revive their economies through key sectors like travel, tourism, and education.

“I don’t have the power to push buttons on the WHO. We at Bharat Biotech are equally, if not more, eager or anxious to get that two lines or paragraph from the WHO, saying Covaxin has been cleared,” Suchitra Ella, co-founder and joint managing director, Bharat Biotech International Limited (BBIL), told Fortune India in a recent interview.

Till date, BBIL has supplied 100 million doses of vaccines to the Government of India and neighbouring countries. The company has been repeatedly saying that its scientific standards are transparent, and has published over nine research studies on Covaxin's safety and efficacy.

As of date, half a dozen Covid-19 vaccines, including those of Pfizer-BioNTech and AstraZeneca-Oxford’s Covishield, have been granted EUL. According to WHO, “EUL is a risk-based procedure for assessing and listing unlicensed 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.” The EUL will also assist UN procurement agencies and member states in determining the acceptability of using specific products, “based on an essential set of available quality, safety, and efficacy and performance data.”

On October 17, Soumya Swaminathan, chief scientist, WHO, tweeted: "The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere.”

The WHO process, said Ella, “is normally 12 to 18 months”, and can go up to 24 months. “There is no such thing that this is an application, I’ve paid for it, and I have to get my application processed in these many days. We have gone through this process for many of our products,” added Ella. But, the public perception, she said, is that there is a delay in Covaxin getting the EUL. “It is not a delay. It is a normal routine process. When the WHO asks for me to substantiate information we respond and we are doing it round the clock,” she added.