Indian Immunological Ltd to produce Covaxin materials from mid-June
By IANS |
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Kolkata: Health workers give the 1st dose of vaccine to the Government workers during increasing numbers of COVID 19 cases in Kolkata 24 May, 2021. (Photo: Kuntal Chakrabarty/ IANS). Image Source: IANS News
New Delhi, May 29 : In a bid to augment India s Covid-19 vaccine production, the Centre has decided to support some public sector companies with grants under Mission Covid Suraksha to help in this endeavour. One such company is the Hyderabad-based Indian Immunological Ltd (IIL), under the National Dairy Development Board.
A technical collaboration agreement has been reached between IIL and Bharat Biotech to supply the drug substance required for manufacturing of Covaxin to the latter, an official statement said.
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According to Bharat Biotech, regulatory approvals for Covaxin are currently in process in at least 60 countries, including the US, Brazil, and Hungary.
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The World Health Organisation (WHO) has said “more information” is “required” from Bharat Biotech, which is seeking emergency use listing (EUL) for its Covaxin vaccine for COVID-19.
The latest ‘Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process guidance document dated May 18 on the WHO website said Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that “more information required”. A pre-submission meeting is expected “to be planned May-June 2021,” the guidance document said.
According to the WHO, submissions to it for prequalification or listing under the emergency use procedure are confidential.
If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely. Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.
(Photo by AFP)
The regulatory approvals for Bharat Biotech s COVID-19 vaccine Covaxin are in process in over 60 countries, including the United States and Brazil, the Hyderabad-based company said on Tuesday. Emergency Use Authorization (EUA) have been obtained in 13 countries with more to follow, it added.
Bharat Biotech further said it has submitted an application for emergency use listing to World Health Organization (WHO)-Geneva, and regulatory approvals are expected in July-September 2021.
Bharat Biotech s statement comes after the WHO said more information is required from the company, which is seeking emergency use listing (EUL) for its COVID-19 vaccine for Covaxin .
The Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process guidance document dated May 18 on the WHO website said Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that more information is required . A pre-submission meeting is expected to be planned May-June 2021, t