Bharat Biotech’s coronavirus vaccine Covaxin is likely to be approved by the World Health Organisation soon, top health ministry sources have told NDTV. The indigenously developed vaccine is yet to receive the Emergency Use Authorisation from the World Health Organisation.
Sources said said Covaxin has been “recognised in 22 countries so far and hopefully, it will be approved by WHO soon”.
The world health body had delayed the clearance on Covaxin, seeking more technical information from the manufacturer, Bharat Biotech.
On October 5, the World Health Organisation held out hope for a speedy green signal, tweeting, “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.”
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.
The Hyderabad-based drug manufacturer has asserted 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 per cent.
The push for international clearance for Covaxin — approved by the Indian Drug Controller in January — has been on for months. The dossier of Bharat Biotech has been under review by technical experts for consideration since July.
The vaccine has received green signal from an expert committee for use in children above the age of 2 years and is now waiting for approval from the country’s drug control authority.