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," 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.
On Monday, Bharat Biotech said it 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, news agency PTI reporter.
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, it added.
(With PTI inputs)
