SWITZERLAND: The World Health Organization (WHO) Wednesday granted the much-awaited Emergency Use Listing (EUL) to Hyderabad-based Bharat Biotech’s Covaxin, a move that will allow people inoculated with the Covid vaccine to travel abroad without restrictions.
“The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the Covaxin vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used,” WHO tweeted.
Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE), which recommended the use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. WHO said Covaxin was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose and is well suited to low and middle-income countries due to easy storage requirements. WHO has so far approved COVID-19 jabs of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna and Sinopharm for emergency use.
The approval for Covaxin came after a long wait. Bharat Biotech had submitted its Expression of Interest (EoI) on April 19 and a pre-submission meeting was held in May-June 2021. The WHO listing is a prerequisite for supplying to the Covax facility, intended to meet the vaccine requirements of poorer countries. “WHO has granted EUL to Covaxin developed by Bharat Biotech, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19,” the organisation said.
Countries can now expedite approvals to import and administer Covaxin, Bharat Biotech said. Unicef, the Pan-American Health Organization (PAHO), and the GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide. This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access, it said.
“Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin,” Bharat Biotech chairman and managing director Krishna Ella said in a release. “The EUL authorisation for Covaxin will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency.” The approval came about after several exchanges between the technical advisory group (TAG) under the WHO and the company. “This marks another successful milestone, more to come shortly,” Raches Ella, clinical lead, COVID-19 vaccines, Bharat Biotech, tweeted after the WHO announcement.
“One more vaccine gets WHO emergency use listing,” WHO Chief Scientist Soumya Swaminathan tweeted.
– THE ECONOMIC TIMES