The health ministry had on September 24 hinted that WHO will grant EUA for Covaxin soon. (File image)
The World Health Organization (WHO) has requested Bharat Biotech for more data on its COVID-19 vaccine Covaxin, news agency ANI has reported.
The WHO's Emergency Use Authorisation (EUA) for the vaccine will be delayed by a few more days, the report said.
Hyderabad-based Bharat Biotech had submitted clinical trial data on Covaxin to the WHO in July in its application for EUA.
Responding to media reports, Bharat Biotech said it was not appropriate to speculate not comment on the expected timeline for the EUA.
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"As a responsible manufacturer with past approvals for our other vaccines , we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines. We are continuing to work diligently on obtaining WHO EUL at the earliest," the company said.
Phase III clinical trials of Covaxin had demonstrated an efficacy rate of 77.8 percent.
The WHO's approval will likely make it easier for Indians who have taken the jab to travel abroad without restrictions.
The health ministry had on September 24 hinted that WHO will grant EUA for Covaxin soon.
"There is a procedure of submitting the documents for approval. WHO's emergency use authorization to Covaxin is expected soon," said Union Minister of State for Health Dr Bharati Pravin Pawar, as quoted by ANI.
NITI Aayog member VK Paul recently said the approval was expected by the end of September.
A WHO expert panel is scheduled to review the clinical trial data of Covaxin on October 5, according to the committee's agenda for the meeting seen by Moneycontrol. Following the review, the Strategic Advisory Group of Experts on Immunization (SAGE) will issue draft recommendations.
The WHO has so far granted EUA to vaccines developed by AstraZeneca (Covishield in India), Pfizer-BioNTech, Johnson & Johnson, Moderna, and Sinopharm.
Covishield is manufactured by Pune-based Serum Institute of India (SII).