Delayed again: WHO seeks more 'clarifications' on made-in-India Covid shot Covaxin

WION Web Team
NEW DELHIUpdated: Oct 27, 2021, 11:34 AM IST
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Bharat Biotech said it found encouraging results after a booster dose was given to trial participants six months from the day they received their second dose Photograph:(Others)

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The World Health Organization’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.

As thousands of Indians who used to work or live abroad are stuck at home country due to lack of global recognition for Covaxin jab which they had taken, the WHO has again delayed approval for the made-in-India Covid shot.

The World Health Organization's technical advisory group on Tuesday requested "additional clarifications" from makers Bharat Biotech for Covaxin in order to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.

According to a source, the WHO Technical Advisory Group has requested more explanation from vaccine maker Bharat Biotech before deciding whether or not to award Covaxin EUL clearance.

Also read | Vaccinated but stuck: Indians await WHO nod for homegrown shot to travel abroad

In a meeting on Tuesday, the WHO's Technical Advisory Group decided to do the final risk assessment after obtaining further data from the manufacturer.

Bharat Biotech, situated in Hyderabad, is due to submit the findings this weekend.

The WHO technical advisory group will meet on November 3 for a final assessment.

“The @WHO independent Technical Advisory Group (TAG) met today & asked for additional clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data is received soon," WHO chief scientist Dr Soumya Swaminathan said in a tweet.


Watch | Covaxin: WHO to meet for emergency use listing

On November 3, the Technical Advisory Group may convene for the final risk-benefit analysis. 

The Technical Advisory Group for Emergency Use Listing (TAG-EUL) advises WHO on whether or not the COVID-19 vaccine should be listed for emergency use under the EUL protocol. 

Last week, the WHO stated that it is awaiting one more piece of information from Bharat Biotech on Covaxin and that it must properly analyse vaccines to verify their safety and that it "cannot take shortcuts" before endorsing one for emergency use.

The timing for the UN health agency's Emergency Use Listing method is contingent on how soon a vaccine manufacturer can supply the data needed for WHO to assess the vaccine's quality, safety, effectiveness, and appropriateness for low- and middle-income countries. 

(With inputs from agencies)