WHO seeks more information for emergency use listing of Covaxin; approval likely by Q3 this year
Bharat Biotech has applied to the World Health Organisation (WHO) for approval for indigenously developed Covid-19 vaccine Covaxin and expects the nod in the third or fourth quarter of this year, a top company official has said.
The World Health Organisation has said that 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.
The company expects the nod in the third or fourth quarter of this year, a top company official has said.
“We’ve started this process with WHO. It’s not an immediate approval that you get. It takes a couple of months. We are quite hopeful that by Q3 or Q4 we will receive our WHO approval,” said Raches Ella, project lead-SARS-CoV-2 vaccine and head of business development & advocacy, Bharat Biotech International Ltd.
“Bharat Biotech, in the past, has been approved by WHO for several other vaccines so we’re not new to this process. We are aware of it,” Ella said at an interactive session organised by the Hyderabad chapter of FICCI FLO over the weekend. He did not offer further details on the issue.
Meanwhile, Hyderabad-based Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 per cent of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin vaccine, sources said in New Delhi on Monday. The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech Ltd told the Central government during a discussion on obtaining the World Health Organisation’s authorisation for emergency use listing for Covaxin, sources said.
“BBIL is confident about obtaining WHO’s emergency use listing,” said a source. Noting that Covaxin has already received regulatory approval from 11 countries, sources said there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.
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