'Additional clarifications' needed from Bharat Biotech to conduct final assessment of Covaxin: WHO

United Nations/Geneva: The World Health Organisation’s technical advisory group has decided that “additional clarifications” are needed from Bharat Biotech to conduct a final “risk-benefit assessment” for the emergency use listing of Covaxin.

“The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure,” WHO said in an email response to PTI.

“The TAG met today (October 26, 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine.

“The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, November 3,” the WHO said in response to a question by PTI on the decision regarding the emergency use listing of Covaxin.

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine’s Emergency Use Listing (EUL).

Last week, the WHO had said it is expecting one additional piece of information from Bharat Biotech regarding Covaxin and emphasized that it has to thoroughly evaluate to ensure vaccines are safe and “cannot cut corners” before recommending a vaccine for emergency use.

The UN health agency said the timeframe for its Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy, and suitability for low- and middle-income countries.

The Covaxin has demonstrated 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 percent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.