The Strategic Advisory Group of Experts on Immunization (SAGE) will meet at the World Health Organisation (WHO) on October 5 to discuss granting the emergency use authorisation (EUA) to Covaxin. According to the WHO, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 for granting EUA to India’s indigenous COVID vaccine Covaxin. Any decision on the emergency use listing of the Bharat Biotech-made Covid-19 vaccine will be taken only after the meeting on October 5.
Hanna Nohynek, SAGE member will be introducing session objective setting, an update on regulatory decisions and an overview of Working Group deliverables. The WHO’s advisory group on immunization will be presented with clinical data of Covaxin’s phase one, two and three trials. During the October 5 meeting, the SAGE will also look at the vaccine’s post-marketing studies on safety, immunogenicity, efficacy and effectiveness. The session will recommend EUA based on the clinical data on Covaxin from phase 1, 2, 3 trials and post-marketing studies on safety, immunogenicity, efficacy and effectiveness. It will update on global, regional and country-level plans for vaccine safety monitoring. The assessment of the SAGE working group on the available pieces of evidence will determine EUA. On Friday Bharat Biotech said it has submitted all the data pertaining to Covaxin to the WHO for Emergency Use Listing (EUL) and is awaiting feedback from the global health watchdog.
Based on the presented evidence, presentation of draft recommendations on the use of Covaxin in priority populations, the SAGE will decide whether to allow it for emergency use. Presentations made during the meeting will be made available online once the meeting has concluded.