World Health Organisation's (WHO) approval for emergency use authorization (EUA) to COVID-19 vaccine Covaxin, developed by Hyderabad-based Bharat Biotech, is expected soon, the health ministry informed on Friday.
Dr Bharati Pravin Pawar, MoS, Health told ANI about the expected WHO's decision, which earlier was reportedly delayed likely till October 5.
Bharat Biotech which developed the vaccine is expected to give a presentation on the Vaccine’s safety and efficacy data of clinical trials (phase 1-3 trial results and post marketing) and Risk management plans and other implementation considerations, according to the SAGE draft agenda on 6 October, according to news agency PTI.
Bharat Biotech recently said it has submitted all the data pertaining to Covaxin to the WHO for EUL and is awaiting feedback from the global health watchdog.
Based on the assessments of the SAGE working group, 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, and all clarifications sought by the UN health agency have been responded to, Bharat Biotech said.
Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.
So far, the WHO has approved Covid-19 vaccines manufactured by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna, and Sinopharm. UN agency’s approval makes international travel easy for people who receive those vaccines and the company also gets a boost to market its product in the global market.
