Hyderabad: Bharat Biotech on Monday said that it has submitted all documents required for emergency use listing (EUL) of indigenously developed Covid-19 vaccine Covaxin have been submitted to the World Health Organisation (WHO).
"All documents required for emergency use listing (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 the WHO at the earliest," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.
The Hyderabad-based company had said in May that that 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.
A WHO pre-qualification, or a EUL, is necessary for a vaccine company to supply vaccines for global facilities such as Covax or international procurement.
The WHO has approved vaccines Pfizer-BioNTech, AstraZeneca- SK Bio/SII, Johnson & Johnson Janssen, Moderna and Sinopharm for emergency use