The Strategic Advisory Group of Experts (SAGE) will arrange a session to recommend emergency use authorization to Covaxin based on clinical data
Indian biotechnology company, Bharat Biotech’s COVID-19 vaccine, Covaxin is likely to receive emergency use authorization (EUA) from the World Health Organization (WHO) on 5th October 2021.
In a statement, WHO said that the Strategic Advisory Group of Experts (SAGE) would be gathering on October 5th for authorizing Covaxin for emergency use authorization.
The session’s objectives will be highlighted by SAGE member Hanna Nohynek with an update on regulatory decisions, and a summary of Working Group deliverables.
The session will assess EUA based on safety, efficacy, immunogenicity, and effectiveness data from phase 1, 2, and 3 trials and post-marketing studies on Covaxin.
It will update vaccination safety monitoring protocols at the global, regional, and national levels. EUA will be determined by the SAGE working group's review of the existing evidence.
Bharat Biotech has recently stated that it has submitted all data to the World Health Organization (WHO) for its COVID-19 vaccine Covaxin's Emergency Use Listing (EUL) and is awaiting comment from the UN Public Health Agency. In a sequence of tweets, Bharat Biotech alleged that Covaxin clinical trial was entirely compiled and obtainable in June 2021.
As a responsible producer with prior sanctions for its other vaccines, the firm said it would not feel it acceptable to speculate or comment on the approval process and its timeframes.
Covaxin was developed by Bharat Biotech in collaboration with the National Institute of Virology and the Indian Council of Medical Research. It is made up of a full virion neutralized SARS-CoV-2 vaccine completed in Vero cells.
As per sources, the vaccine is stable at 2 to 8 degrees Celsius (refrigerated) and comes in a ready-to-use liquid format that can be supplied using current vaccine supply chains.