Bharat Biotech's Covid-19 vaccine Covaxin (file photo). Photograph:( Others )
The SAGE session of the specialised agency of the United Nations will recommend EUA based on the clinical on Covaxin from Phase 1, 2, and 3 trials
The World Health Organization is likely to delay its approval for the Covaxin shot, once again, till October 5 this time. According to a report by the ANI news agency, the Strategic Advisory Group of Experts on Immunisation (SAGE) will be meeting on October 5 to decide on granting the EUA to Covaxin.
The SAGE session of the specialised agency of the United Nations will recommend EUA based on the clinical on Covaxin from Phase 1, 2, and 3 trials.
The session will also consider the post-marketing studies on safety, immunogenicity, efficacy, and effectiveness. Also, it will review updates on global, regional, and country-level plans for vaccine safety monitoring.
Based on the assessment, the WHO will then consider the available pieces of evidence to determine EUA.
The Phase-3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent.
All the relevant trial data has been submitted to WHO for EUL.
“We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines,” said Bharat Biotech in a statement.