The World Health Organization on Monday said it is “expecting one additional piece of information” from Bharat Biotech before it thoroughly evaluates COVAXIN for it to be included in the COVID-19 Emergency Use Listing.
Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis and experts have been reviewing them, it said in a series of tweets from its official Twitter handle, adding that it “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.
Further, it underlined the procedure of attaining EUL and how it is significant for the manufacturing company to submit data within a time frame for the WHO’s evaluation.
“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 said.
In conclusion, the world’s top health body mentioned that it understands the desperation of people who are “waiting for WHO’s recommendation for Covaxin to be included in the COVID-19 EUL”, however, without a complete assessment of all the data sought by the organization, it cannot “come to a final recommendation.
“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,” the WHO said.
On September 28, News18 had reported that the much-awaited approval from the WHO for India’s home-grown coronavirus vaccine manufactured by Hyderabad-based Bharat Biotech, Covaxin, is likely to be delayed by a few more weeks.
This is because WHO has raised some more questions on Covaxin and the queries have been sent to Bharat Biotech for further clarification.
Although a set of technical queries have been sent by the international health watchdog, a source in the WHO said that it’s a routine process and there’s no concern in the matter. “It’s the usual process. Experts raise queries, which need to be answered by the company,” the source had said.
Asked if the fresh set of queries will delay the approval further, the WHO source clarified that it may not cause much delay. “No, it should not be delayed… Maybe a few weeks,” the official said.
The approval for the made-in-India vaccine is much awaited, especially by students, medical tourists, business travellers and people, who have international travel plans.