Bharat Biotech on Tuesday said it expects approval for its COVID-19 vaccine Covaxin from the World Health Organisation for Emergency Use Listing (EUL) during July-September. The company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil
and Hungary among others.
“Application for EUL has been submitted to WHO-Geneva. Regulatory approvals are expected during July-September 2021,” it said in a release.
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 per cent 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 during a discussion on obtaining WHOs authorisation for EUL for Covaxin.
The city based vaccine maker said it has got Emergency Use Authorisation in 13 countries, with more to follow.
Ocugen, Bharat Biotech’s US partner for COVID-19 vaccine Covaxin recently said it has submitted a “Master File” to the US Food and Drug Administration prior to seeking an EUA in that country.
Ocugen has submitted key information and data to date, including pre-clinical studies, chemistry, manufacturing, and controls (“CMC”), and clinical studies as a “Master File” for FDA review and input prior to a planned EUA submission.
The US company is currently waiting for additional data from Bharat Biotech from the ongoing Phase 3 clinical trial for a EUA submission, it further said.
Most countries recommend vaccinations against COVID-19. Unvaccinated travelers can travel with negative RT-PCR tests prior to their journey in the absence of any other country specific restrictions, Bharat Biotech said.