The World health Organisation's (WHO), Strategic Advisory Group of Experts on Immunization (SAGE) will meet in October to make its recommendations on Bharat Biotech’s Covid-19 vaccination Covaxin on Emergency Use Listing.
As per to the SAGE draft agenda, the Bharat Biotech is anticipated to give a detailed presentation on the covid vaccine’s safety and potency data of clinical trials (phase 1-3 trial results and post marketing) with the risk management plans and other implementing considerations.
SAGE is authorised group with counsel WHO on world policies and strategies across the world, ranging from different vaccines & technology, research & development, to delivery of immunization and its linkages with other health interventions.
Hanna Nohynek, who is an official member of SAGE will be presenting a draft that will be recommends the Covid-19 vaccine and the session will make its own recommendations.
The draft agenda said, that the session will thoroughly discuss the clinical data on Bharat Biotech's Covaxin from the three phase trials and post marketing studies on safety, immunogenicity, potency and effectiveness, apart from the update on world, regional and country level plans for vaccine safety monitoring.
Recently, the Bharat Biotech has informed that it has submitted all the data concerning to Covaxin to the WHO for EUL and is expecting a feedback from the world health watchdog.
As per to a update on WHO's website, it said that, presently WHO is reviewing the data that was submitted by the vaccine maker and the date for a decision on the Covid-19 vaccine is yet “to be confirmed.”
In an update on its website, the World organization said it began rolling data of the Covid-19 vaccine on July 6.
Rolling data will permit WHO to began its review right away, as information continously come in to boost the overall review process.
Bharat Biotech's Covaxin is one of the six vaccines that have received emergency use authorisation from the Indian drug regulator and is being used in inoculation programme across the nation, accompanying with other Covid-19 vaccine including Covishield and Sputnik V.