The Strategic Advisory Group of Experts on Immunization (SAGE) of the World health Organisation(WHO) would be meeting in October to make its suggestions on Bharat Biotech's Covid-19 vaccine Covaxin on Emergency Use Listing.Bharat Biotech is suggested to give a representation on the vaccine's safety and efficacy data of clinical trials and Risk management plans and other implementation thoughts, according to the SAGE draft agenda.
SAGE is sanctioned with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to convey interference of immunization and its linkages with other health interventions. Hanna Nohynek, member of SAGE, will be presenting a draft recommendation for the vaccine and the session will make its exhortation.
The session will discuss the clinical data on Covaxin from phase 1, 2, 3 trials and post marketing studies on safety, immunogenicity, efficacy and effectiveness, besides update on global, regional and country level plans for vaccine safety monitoring, the agenda stated. Bharat Biotech recently said it has submitted all the data concerning to Covaxin to the WHO for EUL(Emergency Use Listing Procedure) and is waiting for the feedback from the global health watchdog.
The WHO is currently evaluating the data submitted by the vaccine maker and the date for a decision on the jab is yet "to be confirmed," according to the update available on the WHO website. In an update on its website, the WHO said it began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in, to whisk the overall review process. Covaxin is one of the six vaccines that have received emergency use authorization from India's drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.
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