WHO will decide on 6 October whether to allow emergency use of Covaxin

Bharat Biotech, which developed the vaccine, is expected to review the vaccine’s safety and efficacy data from clinical trials (Phase 1-3 trial results and post marketing) and risk management plans and other implementation considerations. Will make a presentation, as on 6, according to the SAGE draft agenda. According to the news agency October PTI. Bharat Biotech recently said that it has submitted all data related to Covaxin to WHO for EUL and is awaiting a response from the global health watchdog.

SAGE is authorized to advise WHO on overall global policies and strategies, from vaccines and technology, research and development to delivery of vaccinations and its relationship with other health interventions. SAGE member Hannah Nohyneck will present a draft recommendation for the vaccine and the session will make its recommendations.

The agenda states that the session will include updates on phase 1, 2, 3 trials on Covaxin and post marketing studies on safety, immunogenicity, efficacy and effectiveness, as well as global, regional and country-level plans for vaccine safety monitoring. I will discuss in full.

The WHO is currently reviewing the data submitted by the vaccine manufacturer and the date of the decision on the jab “has yet to be confirmed”, according to updates available on the WHO website.

In an update on its website, the WHO said it began rolling out vaccine data on July 6. Rolling data allows WHO to begin its review immediately, as information continues to come in to accelerate the overall review process. Covaxin is one of six vaccines that have received emergency use authorization from India’s drug regulator and is being used along with Covishield and Sputnik V in the nationwide immunization programme.

*With inputs from agencies