The wait for the World Health Organisation (WHO)’s emergency use authorisation (EUA) for Hyderabad-based Bharat Biotech’s COVID-19 vaccine Covaxin is set to be a little longer as the global health body is said to have delayed the approval till 5 October, reports Hindustan Times.
WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) will be meeting on 5 October to decide on granting the EUA to Covaxin. It will be analysing the data from the vaccine’s first, second and third stage clinical trials.
The SAGE will also be considering post-marketing studies on safety, immunogenicity, efficacy, and effectiveness. It will also review updates on global, regional, and country-level plans for vaccine safety monitoring.
It should be noted that Covaxin is the first indigenously developed COVID-19 vaccine in India. It was developed by Dr Krishna Ella led Bharat Biotech in close collaboration with the Indian Council for Medical Research (ICMR) and the Pune-based National Institute of Virology.
Covaxin is presently the second-most administered COVID-19 vaccine in India after Covishield which is being manufactured by the Pune-based Serum Institute of India (SII). The Covishield has been developed by Swedish-British pharmaceutical major AstraZeneca and the University of Oxford.