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LATEST NEWS UPDATES | Covaxin approval sparks questions and clarifications -Rhythma Kaul

Covaxin approval sparks questions and clarifications -Rhythma Kaul

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published Published on Nov 18, 2022   modified Modified on Nov 18, 2022

-Hindustan Times

On November 15, Boston-based health news website Stat News cited official documents that purported to detail a series of problems in how Bharat Biotech’s coronavirus vaccine, funded partly by the government, was approved.

The Union government and vaccine maker Bharat Biotech on Thursday refuted a report that alleged rules and protocols were bent during the approval process for Covaxin, but the clarifications served to further add to the questions that were raised with some specific issues remaining unaddressed.

On November 15, Boston-based health news website Stat News cited official documents that purported to detail a series of problems in how Bharat Biotech’s coronavirus vaccine, funded partly by the government, was approved.

Among these were changes to clinical trial designs without adequate scientific explanation, an unexplained decision to drop what is known as a control group, and multiple occasions when the clinical trials progressed without data from prior stages having come in, especially in the case of the critical large-scale Phase III that began while Phase II results were yet to be determined.

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Hindustan Times, 18 November, 2022, https://www.hindustantimes.com/india-news/covaxin-approval-sparks-questions-and-clarifications-101668707429850.html


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