WHO Experts’ Group to take a call on EUL for Covaxin on October 6

By: |
September 19, 2021 10:18 AM

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.

With very few Covid-19 vaccine candidates having received any form of approval for paediatric use across the globe—even those that have are restricted to a clutch of developed jurisdictions.With very few Covid-19 vaccine candidates having received any form of approval for paediatric use across the globe—even those that have are restricted to a clutch of developed jurisdictions.

The Strategic Advisory Group of Experts on Immunization (SAGE) of the World health Organisation would be meeting in October to make its recommendations on Bharat Biotech’s COVID-19 vaccine Covaxin on Emergency Use Listing.

Bharat Biotech 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.

SAGE is authorised with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery 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 recommendations.

The session will thoroughly 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 said.

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.

The WHO is currently reviewing 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 accelerate the overall review process.

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.

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