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Decision on Covaxin in October, says WHO
World Health Organisation
A decision on Bharat Biotech's submission seeking emergency use listing (EUL) for its Covaxin Covid-19 vaccine will be made in October, the World Health Organisation has said.
United Nations/ Geneva: A decision on Bharat Biotech's submission seeking emergency use listing (EUL) for its Covaxin Covid-19 vaccine will be made in October, the World Health Organisation has said.
The status of assessment for Covaxin is "ongoing". Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine.
The latest 'Status of Covid-19 vaccines within WHO EUL/PQ evaluation process' guidance document dated September 29 on the WHO website said that the decision date for Bharat Biotech's Covaxin is "October 2021".
The WHO said it began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.
According to the WHO, submissions for prequalification or listing under the emergency use procedure are confidential. If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely.
Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.
