NEW DELHI, Sept 27: The expected clearance from the World Health Organization (WHO) for emergency use authorisation (EUA) of Covaxin, the Covid vaccine developed in India, may be further delayed as the global body has sent more technical queries to its manufacturer Bharat Biotech, official sources said.
This setback is likely to adversely affect Indians’, especially students’, international travel plans. Without EUA from the WHO, Covaxin will not be considered an accepted vaccine by most countries around the world. WHO’s queries for Bharat Biotech come despite the Hyderabad-based drug maker asserting that it has submitted all data required for clearance.
The indication of a delay comes merely days after the Union Health Ministry hinted that the global 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 anytime soon,” Dr Bharati Pravin Pawar, the union minister of state for health had stated last week. 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 deployed by India in its massive nationwide inoculation drive against COVID-19 launched in January this year. Others like the Russia-made Sputnik V were added to the country’s armoury later.
Covishield is the only India-made vaccine on the WHO approved 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 China-made Sinopharm.
(Manas Dasgupta)