India

WHO decision on Covaxin EUL likely in October

A health worker prepare during the vaccination drive at a vaccination center, Government Boy's Senior Secondary School, Rajouri Garden in West Delhi on, September 17, 2021

A health worker prepare during the vaccination drive at a vaccination center, Government Boy's Senior Secondary School, Rajouri Garden in West Delhi on, September 17, 2021

The World Health Organisation (WHO) may take a decision on the Emergency Use Listing of India’s COVID-19 vaccine Covaxin in October.

A September 29 update on the status of COVID-19 vaccines with regard to their EUL process indicated that October was the earliest when a decision was likely. Submission of rolling data for Covaxin began on July 6 and the assessment, for the EUL, is underway, WHO said in the document posted on its website. 

The decision date mentioned was only an estimate since it depended on when all the data is submitted under rolling submission as well as when all responses to the assessors’ questions were submitted, a footnote said.

WHO approval for Covaxin is crucial for those inoculated with the indigenously developed vaccine as an EUL could pave way for overseas travel. Though WHO recognition is aimed to facilitate global procurement and use of the vaccines, the approval is widely perceived also as a passport for those who taken the jabs to travel abroad.

EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the aim of expediting the availability of these products to people affected by a public health emergency. This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data, WHO said.

India was expecting the EUL for Covaxin by September . A delay became evident when Covaxin was listed for discussion at the October 5 meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) that advises 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.”

Developed by Bharat Biotech, Covaxin is one of three vaccines being used as part of the inoculation programme in India – Covishield and Sputnik V being the others. While Covishield received WHO EUL in February , approval for the Russian vaccine is on hold and awaiting completion of rolling submission. WHO said the anticipated date for Sputnik’s EUL will be set once all data is submitted and follow-up of inspection observations completed.


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Printable version | Sep 19, 2022 4:34:40 pm | https://www.thehindu.com/news/national/decision-on-bharat-biotechs-covaxin-eul-in-october-who/article36747417.ece