Bharat Biotech on Monday said that it has submitted all documents to the World Health Organisation (WHO) for Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin and that the review process has commenced. Bharat Biotech Chairman and Managing Director Krishna Ella said all documents required for EUL of Covaxin have been submitted to WHO as of July 9. "The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," said Krishna. The Hyderabad-based company had said in May that the application for EUL was submitted to WHO-Geneva and regulatory approvals are expected by July-September 2021.
On June 30, the vaccine maker announced that it is working closely with the WHO for the inclusion of Covaxin in its EUL. "Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past," it had said.
"We are a step closer to the final decision on Covaxin's global acceptance, as the rolling data is slated to begin in July 2021," it added. The company claims that with 10 scientific publications in 12 months, Covaxin is one of the very few vaccines to have extensive data published in globally renowned peer-reviewed journals.
Meanwhile, in another development, Dr Reddy's Laboratories on Monday clarified that the soft launch of COVID-19 vaccine Sputnik V has not been put on hold. "Neither the ongoing soft commercial launch nor work towards its ramp-up in India have been put on hold," the Hyderabad-based company said in a statement.
The pharma major stated that the nationwide soft launch of the Russian vaccine has reached over 50 cities and towns across India. It said it will strengthen the commercial roll-out of Sputnik V in the coming weeks. Starting initially in Hyderabad on Monday, the soft launch roll-out of Sputnik V has scaled up speedily and reached cities and towns all across India, Dr Reddy's said.