The international health body said that it was looking for “one additional piece of information” from Bharat Biotech, the Hyderabad-based company which created the vaccine.
The vaccine, which was India’s first indigenously made Covid jab, is one of three currently being used in the country’s Covid-19 inoculation drive. India’s drugs control body had approved the restricted emergency use of Covaxin in January. It accounts for 11 per cent of the 980 million doses administered in the country so far.
“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners — before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” the WHO said in a series of tweets on Monday.
“Bharat Biotech — the manufacturer of Covaxin — has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data. WHO is expecting one additional piece of information from the company today,” it added.
Bharat Biotech first submitted documents and the initial set of this “rolling data” for WHO approval in July. The health body has said it will analyse the information as and when it comes in.
“The timeframe for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries,” the WHO wrote.
“When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine,” it added.
The WHO’s technical advisory group is scheduled to meet on 26 October to consider the listing for Covaxin. However, the health body has not specified which documents it has sought from the pharma company.
The delay in approval for Covaxin has been a concern for Indians who have been inoculated with the jab. Without the WHO’s approval, Covaxin is unlikely to be accepted as a valid vaccine around the world. Bharat Biotech will also be unable to export its vaccine without the WHO’s nod.
The approval of Covaxin within India was itself controversial, as it came before Bharat Biotech had published the results of its own phase three trials. The approval was nonetheless largely celebrated as a success story of indigenous production by Indian prime minister Narendra Modi and his cabinet colleagues.
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