Decision On Covaxin Clearance Next Week, Says WHO

Covaxin, India's indigenously developed coronavirus vaccine, may be cleared by the World Health Organisation as early as next week when the UN agency and an independent group of experts meet. This comes almost a week after WHO delayed the emergency use authorisation (EUA) for Covaxin as the global body sent more technical queries to its manufacturer, Bharat Biotech.

"WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin," WHO tweeted.

Bharat Biotech "has been submitting data to the WHO on a rolling basis and submitted additional info at WHO's request on 27 September", another tweet read.

"WHO experts are currently reviewing this info and if it addresses all questions raised, the WHO assessment will be finalised next week."

Without the EUA, Covaxin will not be considered an accepted vaccine by most countries around the world. WHO's queries for Bharat Biotech came despite the Hyderabad-based drug maker asserting that it has submitted all data required for clearance. According to them, Phase III clinical trials of Covaxin had demonstrated an efficacy rate of 77.8%.

Covaxin, along with Covishield, was the vaccine first deployed by India in its massive nationwide inoculation drive against coronavirus launched in January this year. Others like the Russia-made Sputnik were added to the country's armoury only later. Covishield, manufactured by the Serum Institute of India and developed by researchers at Oxford and AstraZeneca, is the only India-made vaccine on the WHO list now.

Last month, Junior Health Minister Bharati Pravin Pawar had said WHO's authorisation to Covaxin was "expected soon". "There is a procedure of submitting the documents for approval. WHO's emergency use authorisation to Covaxin is expected soon," she had said, according to a report by the news agency ANI.