Bharat Biotech’s Covaxin is likely to receive the emergency use listing (EUL) by the World Health Organization (WHO) this week, a top expert in India’s official vaccination planning body has said.
The EUL will pave the way for a wider recognition of Covaxin in documentation sought by many countries that have made an inoculation mandatory for entry into their borders. In the past, students who sought to study abroad were left in the lurch because Covaxin is recognised as a coronavirus vaccine only in few countries.
“I hope this week we get the WHO EUL. The company has submitted all the relevant documents; the vaccine safety data has also been submitted to WHO. So, we are hoping this week we should get it,” said Dr NK Arora, chairman, Covid-19 working group of National Technical Advisory Group on Immunisation.
On July 12, Bharat Biotech announced that it submitted all documents required for EUL to WHO on July 9. “The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest ,” said Krishna Ella, chairman and managing director of Bharat Biotech, in a statement earlier.
Bharat Biotech also attended a pre-submission meeting with representatives of WHO on June 23.
{{/usCountry}}Bharat Biotech also attended a pre-submission meeting with representatives of WHO on June 23.
{{/usCountry}}While the Indian regulator has approved six coronavirus vaccines for emergency use, Covaxin and Serum Institute of India-manufactured Covishield are the mainstay of the country’s inoculation campaign. Covishield, the India-manufactured version of the Oxford-AstraZeneca vaccine AZD1222, accounts for close to 90% of the 750 million doses administered till Monday. Covishield has already received a WHO EUL.
Covaxin has been developed by the Hyderabad-based vaccine major and the Indian Council of Medical Research.
According to people familiar with the matter, WHO began a rolling review of Covaxin on July 6, 2021, and even though the review is still ‘ongoing’, it is a matter of time before an approval is granted.
According to the UN health body, 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.
This will assist interested 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 June 22, the subject expert committee of the central drugs standards control organisation (CDSCO) assessed Bharat Biotech’s phase 3 clinical trials data of Covaxin, and found the inactivated whole virion vaccine to be 77.8% efficacious in preventing symptomatic Covid-19.