NEW DELHI: In a major setback to leading Indian vaccine manufacturer Bharat Biotech, the World Health Organization (WHO) has further delayed the emergency use authorisation (EUA) for its COVID-19 vaccine Covaxin. Media reports said quoting sources that the global health watchdog has sent more technical queries to its manufacturer Bharat Biotech.
All this comes days after Bharat Biotech claimed that it has submitted all data required for clearance of Covaxin
Though there is no official confirmation around it as yet, the delay is likely to adversely affect Indians’, especially students’, planning to travel abroad.
Without EUA, Bharat Biotech-manufactured Covaxin will not be considered an accepted vaccine by most countries around the world.
Interestingly, Union Health Ministry had recently given indications that the global body was likely to give its nod to Covaxin 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, had said last Friday, according to news agency .
Earlier, Dr VK Paul, Chairperson of the National Expert Group on Vaccine Administration, had also said that WHO’s approval for Covaxin was likely to come before the end of this month.
According to Bharat Biotech, Phase III clinical trials of Covaxin had demonstrated an efficacy rate of 77.8 per cent.
Covaxin, along with Covishield, was the vaccine first authorised by India in its massive nationwide inoculation drive against COVID-19 launched in January this year. Others like the Russia-made Sputnik were added to the country’s armoury only later.
Covishield is the only India-made vaccine on the WHO list now. It is manufactured by the Serum Institute of India in Pune and was developed by researchers at Oxford University and pharmaceutical firm AstraZeneca.
The WHO has, till now, also approved vaccines manufactured by Pfizer-BioNTech, Johnson and Johnson, Moderna, and Sinopharm.