The World Health Organization (WHO) has once again delayed the emergency use authorisation (EUA) for Covaxin, the Covid-19 vaccine developed in India, and sent for more technical queries to its Hyderabad-based manufacturer Bharat Biotech, according to reports.
This comes even after Bharat Biotech has said it has submitted all data required for clearance of Covaxin. News18 news television channel 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 person cited above said.
"No, it should not be delayed… Maybe a few weeks," the WHO official told News18 when asked if the fresh set of queries will delay the approval further.
Without the WHO nod, Covaxin will not be considered an accepted vaccine by most countries across the world and the delay is likely to affect students, medical tourists, business travellers and those who want to travel abroad.
Last Friday, 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.
Before that, Dr VK Paul, chairperson of the National Expert Group on Vaccine Administration, also said that WHO's approval for Covaxin was likely to come before the end of this month.
Bharat Biotech said it has submitted all the necessary documents required for approval on July 9. " The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," Dr Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement.
Covaxin and Serum Institute of India's Covishield were the Covid-19 vaccines first used by the central government in its massive nationwide inoculation drive launched in January this year. Russia-made Sputnik was later added to the country's vaccination drive. Covishield is the only India-made vaccine on the WHO list now.