Bharat Biotech on Tuesday said that regulatory approvals for its COVID-19 vaccine Covaxin are in process in over 60 countries including the USA, Brazil and Hungary among others.
The firm added that it expects Emergency Use Authorisation (EUA) approval from the World Health Organisation (WHO) in July-September.
“Application for Emergency Use Listing submitted to WHO-Geneva, regulatory approvals are expected Jul-Sept 2021,” Bharat Biotech said in a statement.
— BharatBiotech (@BharatBiotech) May 25, 2021
Bharat Biotech added that it has obtained EUA for Covaxin in 13 countries so far with more to follow.
Emergency Use Listing (EUL) is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies, according to WHO guidelines. 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 WHO website said. Sources had earlier indicated that Bharat Biotech International Limited (BBIL) has conveyed to the Centre that it has already submitted 90 percent of documents to WHO for obtaining EUL for Covaxin.
The remaining documents are expected to be submitted by June, the city-based vaccine maker reportedly had told the Central government.
(With inputs from PTI)