WHO delays Covaxin approval, seeks additional clarifications from Bharat Biotech

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Bharat Biotech’s Covid vaccine Covaxin. (Representational picture)

The World Health Organisation’s technical advisory group on Tuesday sought “additional clarifications” from Bharat Biotech for its COVID-19 vaccine Covaxin to conduct a ultimate “risk-benefit assessment” for Emergency Use Listing of the vaccine.

The technical advisory group will now meet on November 3 for a ultimate evaluation.

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).

The technical advisory group met on Tuesday to evaluation knowledge on Covaxin for the emergency use itemizing of India’s indigenously-made vaccine.

“The TAG met immediately (26 October 2021) and determined that additional clarifications from the producer are wanted to conduct a ultimate EUL risk-benefit evaluation for world use of the vaccine,” the WHO stated in an e mail response to a query by PTI on the choice relating to the Emergency Use Listing of Covaxin.

“The TAG expects to obtain these clarifications from the producer by the tip of this week, and goals to reconvene for the ultimate risk-benefit evaluation on Wednesday, 3 November,” it added.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an impartial advisory group that gives suggestions to WHO on whether or not a Covid 19 vaccine will be listed for emergency use below the EUL process.

Earlier Tuesday, WHO spokesperson Dr Margaret Harris had stated that on COVAXIN, the technical advisory group that critiques all the information for a possible emergency use itemizing was reviewing that knowledge.

“Now if all is in place, and all goes effectively, and if the committee is happy, we might count on a suggestion throughout the subsequent 24 hours or so,” she had stated throughout a press briefing.

The Covaxin has demonstrated 77.8 per cent effectiveness towards symptomatic COVID-19 and 65.2 per cent safety towards the brand new Delta variant.


In June, the corporate stated it concluded the ultimate evaluation of Covaxin efficacy from Phase 3 trials.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the 2 broadly used vaccines in India.

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

Last week, the WHO had stated it’s anticipating one additional piece of data from Bharat Biotech relating to Covaxin and emphasised that it has to totally consider to make sure vaccines are secure and “cannot cut corners” earlier than recommending a vaccine for emergency use.

WHO has stated the timeframe for its Emergency Use Listing process depends on how shortly an organization producing the vaccine is ready to present the information required for WHO to guage the vaccine’s high quality, security, efficacy and its suitability for low- and middle-income nations.

“When the data offered addresses all questions raised, WHO and the Technical Advisory Group will full the evaluation and are available to a ultimate suggestion whether or not to grant Emergency Use Listing to the vaccine,” it has stated.

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, 2021-10-27 00:17:26

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