News Analysis India

Tag: Emergency Use Listing

  • Bharat Biotech awaits feedback from WHO for Covaxin EUL

    By PTI

    HYDERABAD: Bharat Biotech on Friday said it has submitted all the data pertaining to its COVID-19 vaccine Covaxin to the World health organisation for Emergency Use Listing (EUL) and is awaiting feedback from the global health watchdog.

    The WHO is currently reviewing the data submitted by the vaccine maker and the date for a decision on the jab is yet “to be confirmed,” according to the update available on WHO website.

    “#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,” Bharat Biotech tweeted.

    As a responsible manufacturer with past approvals for its other vaccines, the company said it would not find it appropriate to speculate or comment on approval process and its timelines, it further said.

    “We are continuing to work diligently on obtaining WHO EUL at the earliest,” the vaccine maker added in a series of tweets.

    In an update on its website, 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.

    Suchitra Ella, joint managing director of Bharat Biotech recently had earlier said the EUL process is a step closer to the final decision on Covaxin’s ‘global acceptance’.

  • WHO assessing Covaxin data for Emergency Use Listing; decision date ‘to be confirmed’

    By PTI
    HYDERABAD: The World Health Organisation, which is currently reviewing Bharat Biotech’s application for an Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin, has said it is assessing the data of the jab.

    In an update on its website, the WHO, which began rolling data on July 6, said the date for a decision on the jab is yet “to be confirmed”.

    Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.

    Suchitra Ella, joint managing director of Bharat Biotech, had recently said the EUL process is a step closer to the final decision on Covaxin’s ‘global acceptance’ as the rolling data was slated to begin in July.

    She also, in a tweet, said the company was working closely with the WHO for inclusion of Covaxin in its EUL and approval is not expected to be a long drawn process as cell line and majority of Bharat Biotech’s facilities have already been audited and approved by the global health watchdog for BBIL’s other vaccines in the past.

    The city-based vaccine maker recently said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

    The jab demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the B.1.617.2 Delta variant, it said.