Bharat Biotech submits 90% documents of Covaxin for WHO nod on emergency use


The indegenous Coronavirus vaccine- Covaxin developed by Bharat Biotech, despite getting emergency approvals in India for, the vaccine has still not received emergency use authorization from the World Health Organization. So far, for the Emergency Use Listing of Covaxin, the vaccine manufacturer has submitted ninety per cent of the documents to the WHO and the remaining are expected to be sent in June. The firm informed regarding the documentation to the central government on Monday and said it is confident that WHO will approve the vaccine for emergency usage, a report by The IE noted.

The document dated May 18- ‘Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process’ has stated that the Bharat Biotech had submitted EOI (Expression of Interest) on April 19 to which, the organisation reverted there is need for more information. According to the report, a pre-submission meeting is expected which will be planned by June.

submissions that have been made till now for prequalification or listing under the emergency use procedure have been kept confidential and once the criteria is met during the assessment, WHO will reveal the results for everyone. It is to note that the duration of the emergency use listing process is dependent on the quality of the data that the vaccine manufacturer has submitted and if that meets the WHO criteria, the report said.

To be sure, more than 2 crore Indians have been given Covaxin shots and this includes some senior government officials. The approval for the vaccine by the WHO has now become necessary for all these people as there are discussions going on regarding vaccine passports provisions to only those who have taken the WHO-approved vaccines.

So far, Covaxin has received regulatory approvals from 11 countries whereas another 11 companies in seven countries have shown interest in technology transfer as well as production of Covaxin. Since vaccines developed in the past by Bharat Biotech have been given WHO approvals, the company is now confident on obtaining approvals for Covaxin as well.

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