Bharat Biotech expects WHO emergency use listing for Covaxin in July-September

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.

Read also: WHO seeks more information from Bharat Biotech for Covaxin emergency use listing

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.

Read also: Bharat Biotech American partner submits Covaxin Master File to USFDA

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.