The World Health Organization (WHO) has further delayed Covaxin’s emergency use authorisation (EUA), citing more technical queries to its manufacturer Bharat Biotech. The delay in approval would affect the nationals and also the Indian students and international travels. However, the fresh set of queriers may not delay the approval further. “No, it should not be delayed… Maybe a few weeks,” told an official of the WHO to News18.
The report comes after the manufacturer Bharat Biotech said that it submitted all the necessary data to obtain clearance of Covaxin. The Union Health Ministry also indicated that Covaxin was likely to be approved anytime soon. According to a media report, Dr Bharati Pravin Pawar, Union Minister of State Health Ministry, said last week, “There is a procedure of submitting the documents for approval. WHO’s emergency use authorisation to Covaxin is expected soon.”
Also, the Chairperson of the National Expert Group on Vaccine Administration, Dr VK Paul, earlier said that Covaxin is likely to be approved by the WHO before the end of this month.
If Covaxin does not get the EUA, it would not be considered an approved vaccine by most countries.
Phase III clinical trials of the Covaxin vaccine has shown a 77.8 per cent efficacy rate, according to the manufacturer of Covaxin, Bharat Biotech.
This makes Covishiled the only India-manufactured vaccine recognised by the WHO at present. Covishield is manufactured by the Serum Institute of India, developed by Oxford University and AstraZeneca.
Till now, the vaccines approved by the WHO include those manufactured by Pfizer-BioNTech, Moderna, Johnson and Johnson, and Sinopharm.