Emergency use authorisation (EUA) for Covaxin, the COVID-19 vaccine developed in India, has once again been delayed by the World Health Organisation according to multiple reports.
It has sent for more technical queries to its Hyderabad-based manufacturer Bharat Biotech. This comes even after Bharat Biotech has said it has submitted all data required for clearance of Covaxin.
News18 reported cited a person familiar with the matter as saying that this is a routine process and there is no concern in the matter. "It's the usual process. Experts raise queries, which need to be answered by the company," the official cited above said.
However, NDTV reports that the queries for Bharat Biotech come despite the Hyderabad-based drug maker asserting that it has submitted all data required for clearance.
Without the EUA, Covaxin will not be considered an accepted vaccine by most countries around the world, making it difficult for Indians who have taken the dose to travel internationally.
Last week, the Union Ministry of Health and Family Welfare hinted that the global health body was likely to give its nod anytime soon. "There is a procedure of submitting the documents for approval. WHO's emergency use authorisation to Covaxin is expected soon," Dr Bharati Pravin Pawar, Union minister of state in the health ministry, said, according to news agency ANI.
The WHO has so far approved Covid vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China's Sinopharm and Oxford-AstraZeneca for emergency use.
As per Bharat Biotech, Phase III clinical trials of Covaxin had demonstrated an efficacy rate of 77.8 percent.
Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.
With inputs from agencies