WHO likely to approve Bharat Biotech's Covaxin this week: Report
By Team Newsable | First Published Sep 13, 2021, 6:52 PM ISTThe WHO’s emergency approval will allow Bharat Biotech to export Covaxin and also ease international travel of people who have received this vaccine.
New Delhi: Amid fear of a third possible wave of deadly Covid-19, the World Health Organization’s (WHO) approval for Bharat Biotech's Covid-19 vaccine, Covaxin, is expected this week, sources said on Monday.
The WHO’s emergency approval will allow Bharat Biotech to export Covaxin and also ease international travel of people who have received this vaccine.
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On September 1, it was reported that the Bharat Biotech vaccine would get WHO's emergency use approval by mid-September. A WHO panel was to meet in the first week of September to review the data submitted by the vaccine maker.
"A series of meetings are taking place to assess pre-clinical and clinical data, leading to a crucial decision which is likely by September mid," a source told The Economic Times.
Union Health Minister Mansukh Mandaviya had also earlier met WHO Chief Scientist Dr Soumya Swaminathan and held discussions over the approval of Bharat Biotech's Covid-19 vaccine Covaxin.
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News agency ANI quoted sources on Monday as saying that Bharat Biotech made available all the necessary documents and data related to the trial to the organisation in the month of July.
"Bharat Biotech has submitted its Phase 3 clinical trials data that demonstrated 77.8% efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO)," ANI reported.
Bharat Biotech, meanwhile, said it was exploring opportunities with its international partners who have expertise in commercial-scale manufacturing of inactivated viral vaccines.
"We want to ensure that Bharat Biotech can ably meet the demand for COVAXIN such that individuals across the country, and the globe, have access to the vaccine," chairman and managing director Krishna Ella said in a statement.
Covaxin is one of the three vaccines that is being administered in the country. The drug regulator in the country has given Emergency Use Authorisation (EUA) to Moderna and Johnson and Johnson.
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