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Pharma wrap: Why Bharat Biotech s Covaxin trial site in Bhopal is stirring up controversy
There were allegations of certain violations in the Phase-III clinical trial taking place at People’s College of Medical Sciences and Research Centre in Bhopal to assess the efficacy and safety of the vaccine.
Bharat Biotech s Covaxin was granted restricted emegency use approval in clinical trial mode on January 2.
Vaccine maker Bharat Biotech on January 9 said the death of a 45-year-old volunteer in Bhopal during the Phase-III clinical trials of its coronavirus vaccine was not related to the vaccine.
“The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing,” the company said in a statement. “We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.” ....

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