Covaxin Controversy: Bharat Biotech did not submit phase-3 data to WHO

Shortly afer the reports went viral after two major news channels began flashing the news, Bharat Biotech refuted these reports

By   |  Business Bureau  |  Published: 17th Jun 2021  9:22 pmUpdated: 17th Jun 2021  9:34 pm
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Hyderabad: A major controversy erupted when there were reports claiming that Bharat Biotech submitted its phase-3 data to the World Health Organization (WHO) for getting approval under the Emergency Use Listing (EUL) mechanism, raising hopes to millions of travellers who were waiting for the EUL clearance for Covaxin.

Shortly afer the reports went viral after two major news channels began flashing the news, Bharat Biotech refuted these reports. Following the news channels ran the stories, a couple of news agencies too picked up the story adding to the confusion. The sum and subtance of these stories was that the company submitted its phase-3 trial data to the WHO.

But Bharath Biotech took to twitter shortly afterwards with a clarification: “The news reports on Bharat Biotech submitting Phase-3 data to WHO is incorrect and lacks any evidence.”

Pre-submission meeting with WHO

However, the fact was that Bharat Biotech’s pre-submission meeting was scheduled on June 23 for evaluation of the WHO’s Emergency Use Listing (EUL) of its indigenous Covid-19 vaccine Covaxin. the reports however spoke of bharat biotch submitting phase – 3 data, which was incorrect.

The WHO Emergency Use Listing procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines to expedite the availability of these products to people affected by a public health emergency. This will assist UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.

Bharat Biotech has supplied more than 40 million doses to date. The company has so far invested over Rs 500 crore and is investing in new facilities and repurposing existing ones across several States for enhancing the production of Covaxin. Product development activities towards the development of vaccines against newer variants is also underway at its facilities.

Covaxin is among three vaccines currently being administered in India against the Covid-19 pandemic.


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