WHO to take final decision next week on approval to Bharat Biotech’s Covaxin

New Delhi, October 5

The WHO will take a call on granting Emergency Use Listing (EUL) status for Bharat Biotech’s Covid-19 vaccine Covaxin next week, the global health body said on Tuesday.

“WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,” the global health body tweeted.

The Strategic Advisory Group of Experts on Immunization (SAGE) of the WHO met on Tuesday to make its recommendations on Covaxin on EUL, among other issues.

“Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional info at WHO’s request on 27 September. WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalized next week,” WHO said in a series of tweets.

The Emergency Use Listing process – done by WHO and the Technical Advisory Group of independent experts – is centred on determining if a manufactured product (e.g. a vaccine) is quality-assured, safe and effective, it said in another tweet.

Bharat Biotech gave 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.

According to the agenda, Hanna Nohynek, a member of SAGE, is expected to present a draft recommendation for the vaccine and the session will make its recommendations.

The WHO is currently reviewing the data submitted by the vaccine maker and the date for a decision on the jab is “October 2021” according to the update available on the WHO website.

The indigenously developed Bharat Biotech’s 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 anti-Covid-19 inoculation programme along with Covishield and Sputnik V.