New Delhi, Oct 05, 2021: An expert panel of the World Health Organisation (WHO) is going to take a decision on emergency use listing (EUL) authorisation of Bharat Biotech’s Covid-19 vaccine Covaxin at 4:45 pm on Tuesday.
Developed by Bharat Biotech in partnership with the National Institute of Virology and ICMR, Covaxin displayed an efficacy of nearly 78 per cent in clinical trials.
While it was approved by the Indian government for emergency use in January this year, it still awaits a nod from WHO for emergency use approval.
Currently, WHO has granted emergency use authorisation to six Covid-19 vaccines - Pfizer-BioNTech jab, Astrazeneca vaccine being manufactured by SK Bio and Serum Institute of India (SII), AstraZeneca EU, Janssen, Moderna, and Sinopharm.
Last week, Bharat Biotech in an official statement clarified that it is working with the WHO for approval of emergency use authorisation (EUA) for Covaxin after reports of delay surfaced.
According to reports, Bharat Biotech had submitted all documents required for the listing to the WHO by 9 July, and the WHO review process, which takes close to six weeks, had commenced by July-end.
If granted, the EUA of Covaxin would enable its recipients to travel abroad without mandatory quarantine.
Meanwhile, Bharat Biotech’s chairman and managing director Dr Krishna Ella told India Today on Saturday that the company has also submitted the trial data for children in the 2-18 years age group to the Drugs and Comptroller General of India (DCGI).
This comes after it completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September.