BackData for clearance of Covaxin given to WHO, it has to take a decision: Centre
Earlier in the day, WHO said that the final decision on Bharat Biotech's submission on emergency use listing (EUL) for its Covaxin COVID-19 vaccine will be made in October 2021.
PremiumCentre on Thursday said that it has submitted data needed for clearance of Covid vaccine Covaxin to World Health Organisation (WHO). And, now WHO to take a decision.
While speaking at a press conference regarding the COVID-19 situation in the country, ICMR DG Dr. Balram Bhargava said, “All the data has been given on which clearance is given by WHO. The data is being looked at, WHO to take a decision."
Earlier in the day, WHO said that the final decision on Bharat Biotech's submission on emergency use listing (EUL) for its Covaxin COVID-19 vaccine will be made in October 2021.
The status of assessment for Covaxin is "ongoing" as of now, the WHO informed in a document citing the status of COVID vaccines. On the WHO website, the decision date for Bharat Biotech's Covaxin is October 2021.
The Hyderabad-based firm had submitted EOI (Expression of Interest) for Covaxin to WHO in April this year. The duration of the emergency use listing process depends on the quality of the data which is submitted by the vaccine manufacturer.
News agency ANI reported that WHO sources informed that WHO has also asked for additional data from Bharat Biotech for Covaxin.
Meanwhile Covaxin maker said that the company has responded to clarifications sought by WHO and is awaiting further feedback. "As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines," a statement from Bharat Biotech informed.
According to Bharat Biotech Covaxin Phase 3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent.
(With inputs from agencies)
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