HYDERABAD: The World Health Organisation’s (WHO) Strategic Advisory Group of Experts on Immunisation (SAGE) will be meeting on October 5 to discuss and consider for recommendation the emergency use listing (EUL) of India’s first indigenously developed Covid-19 vaccine Covaxin.
As per the draft agenda of the SAGE meeting uploaded on WHO’s website, Bharat Biotech will be making a presentation to the expert group on the safety and efficacy data of the vaccine’s Phase-1, 2 and 3 clinical trial results along with the risk management plans and other implementation considerations.
During the meeting SAGE will discuss the Covaxin clinical trials data from phase 1, 2, 3 and post marketing studies on safety, immunogenicity, efficacy and effectiveness as well as the outline of ongoing and planned studies on its safety and effectiveness along with update on global, regional and country level plans for vaccine safety monitoring.
After the group assesses the evidence, SAGE member Hanna Nohynek will present the draft recommendation for the vaccine. “Based on the presented evidences, the expert panel will present its draft recommendations on the use of Bharat Biotech’s vaccine in priority populations,” the SAGE agenda said.
