The World Health Organization has said that the process of assessing Bharat Biotech's COVID-19 vaccine, Covaxin, is underway and a decision regarding its emergency use listing (EUL) will be made in October.
The Hyderabad-based company applied for WHO approval on 19 April, by providing Expression of Interest (EoI).
In a document dated 29 September and titled 'Status of COVID-19 vaccines within WHO EUL/PQ evaluation process' the WHO stated that the decision date for the vaccine is October 2021.
Further, the global health body has said that it started rolling the data of Covaxin on 6 July, news agency PTI reported. Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.
In a tweet earlier this month, Bharat Biotech had stated, "COVAXIN clinical trial data was fully compiled & available in June 2021. All Data submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by WHO and are awaiting further feedback."
Submissions made by vaccine manufacturers for listing under emergency use procedure are strictly confidential, the WHO stated. However, if a product meets the criteria for prequalification, the global health watchdog makes its results available in the public domain.
Further, the time taken for the emergency listing assessment is based on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, PTI reported.
(With inputs from PTI.)
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