Bharat Biotech’s Kovid Vaccine Covaxin. (representative image)
The World Health Organization’s technical advisory group on Tuesday sought “additional clarification” from Bharat Biotech for its COVID-19 vaccine Covaxin, to conduct a final “risk-benefit assessment” to list the emergency use of the vaccine.
The Technical Advisory Group will now meet on November 3 for the final evaluation.
Hyderabad-based Bharat Biotech, which has developed Covaxin, submitted the EOI (Expression of Interest) to the WHO on April 19 for the Emergency Use List (EUL) of the vaccine.
The Technical Advisory Group met on Tuesday to review data on Covaxin for the Emergency Use List of India’s indigenously manufactured vaccine.
“TAG met today (26 October 2021) and decided that the global use of the vaccine requires additional clarification from the manufacturer to conduct a final EUL risk-benefit assessment,” WHO said in an emailed response to a PTI query. said in. Decision regarding the emergency use list of Covaxin.
“Tag expects to receive these clarifications from the manufacturer by the end of this week, and aims to regroup for a final risk-benefit assessment on Wednesday, November 3rd,” it added.
The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to the WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL process.
Earlier on Tuesday, WHO spokeswoman Dr Margaret Harris said that on COVAXIN, the technical advisory group reviewing all data for a potential emergency use list was reviewing that data.
“Now if everything is done, and all is well, and if the committee is satisfied, we would expect a recommendation within the next 24 hours,” he had said during a press briefing.
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 had finished the final analysis of Covaxin efficacy from Phase 3 trials.
Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are two widely used vaccines in India.
WHO has so far approved Covid-19 vaccines from Pfizer-BioNtech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna and Sinopharm for emergency use.
Last week, the WHO said it was expecting an additional information about Covaxin from Bharat Biotech and stressed that the vaccines are safe and “corners to be cut” before recommending the vaccine for emergency use. Can’t” would have to be thoroughly evaluated to be sure.
The WHO has said that the deadline for its emergency use list process depends on how quickly the vaccine maker will be able to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries. able to provide the required data. .
“When the information provided addresses all questions, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation on whether to provide the vaccine with an emergency use list,” it said.
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