India: Bharat Biotech submits anti-Covid vaccine data to WHO

Hyderabad - Covaxin vaccine dossier to be completed and taken up for review only after company submits entire phase-3 clinical trials data

By Web report

Published: Fri 18 Jun 2021, 11:35 AM

Last updated: Fri 18 Jun 2021, 11:36 AM

Bharat Biotech has submitted additional data sought by the World Health Organisation (WHO) for its anti-Covid vaccine, a company spokesperson told a newspaper.

The pre-submission meeting with WHO officials is due to be held next week. But the company’s Covaxin dossier would be completed and taken up for review only after it submits its entire phase-3 clinical trials data.

On Thursday, the company had denied that it had submitted phase-3 trial data of the vaccine to the WHO for approval.

“We have been in discussions with the WHO pre-qualification team and they know exactly what we are doing and what status we are in,” the official told the newspaper.

“The good thing is that we have several WHO prequalified vaccines. Its not like a new company going for WHO prequalification. All our QC, QA, everything is audited for our other vaccines.”

An interim analysis of its phase-3 trials, conducted on 25,800 volunteers in India, had shown an overall efficacy of 78 per cent. The company is now conducting a phase-3 study on 4,500 volunteers in Brazil and will later conduct a trial in the US as well.


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