WHO nod for Covaxin may take ‘few more weeks’ over technical queries; routine, says Health Body

WHO nod for Covaxin may take ‘few more weeks’ over technical queries; routine, says Health Body

Bharat Biotech, last week, had again announced that the company has submitted all the relevant data to the WHO for emergency use

The much-awaited approval from the World Health Organisation (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 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.

WHO nod for Covaxin may take ‘few more weeks’ over technical queries; routine, says Health Body
Paediatric Covaxin: Bharat Biotech completes phase 2/3 trials, may submit data to DCGI by next week

Bharat Biotech, last week, had again announced that the company has submitted all the relevant data to the WHO for emergency use listing (EUL) of Covaxin and is now awaiting feedback.

So far, over 9.28 crore doses of Covaxin have been administered in India.

APPROVAL IN PIPELINE SINCE JULY

Bharat Biotech had submitted all the necessary documents required for the EUL on July 9. “All documents required for EUL of Covaxin have been submitted to WHO as of July 9. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest,” Dr Krishna Ella, chairman and managing director of Bharat Biotech, had said in a statement.

This statement, in July, was released days after Suchitra Ella, the company’s co-founder and joint managing director, said that the approval from the world health body is not expected to be a “long-drawn process”.

“We are working closely with the World Health Organisation for the inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” Suchitra Ella had tweeted.

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