The Strategic Advisory Group of Experts on Immunization, (SAGE) would be making recommendations to the Emergency Use Listing (EUL) of World Health Organisation on Bharat Biotech’s COVID-19 vaccine, Covaxin. Covaxin is one of the six vaccines that are being used in India’s nationwide inoculation program, along with Sputnik V and Covishield.
WHO receives advice on overall global policies and strategies regarding technology, research and development of vaccines, immunization strategies and other health interventions, form SAGE. According to SAGE draft agenda, Bharat Biotech is required to do a presentation on the efficacy data of clinical trials and risk management plans along with the safety and other considerations for implementation by October.
On October 6th, Hanna Nohynek, a member of SAGE will present a draft recommendation for Covaxin and the session will discuss the clinical data on Covaxin from 1st ,2nd and 3rd trial phases. The session will make its recommendations while discussing thoroughly about post marketing studies on safety, efficacy and effectiveness and immunogenicity. The session will also discuss about plans for vaccine safety monitoring on global, regional and country levels.
The World Health Organisation is currently reviewing the data submitted by Bharat Biotech. The overall review process is accelerated by the availability of rolling data of Covaxin from July 6. Bharat Biotech has recently made a statement that it is awaiting feedback from the global health monitor as the data concerning Covaxin for EUL has been submitted without any delay.