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Pharma Wrap: Why Bharat Biotech's Covaxin Trial Site In Bhopal Is Stirring Up Controversy

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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No consent, no follow-up, claim Bhopal gas tragedy victims in vaccine trial

No consent, no follow-up, claim Bhopal gas tragedy victims in vaccine trial
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Last Updated: Jan 10, 2021, 08:10 PM IST
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Trial participants in Bhopal, who, incidentally, are also victims of the 1984 gas tragedy, told IANS of severe violations of the model code of conduct pertaining to trials including absence of consent and no follow-up on their health after developing adverse reactions post the first dose by a particular clinical trial site.
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New Delhi: Ahead of the nationwide rollout of the immunisation programme against the Covid-19, alleged violations of protocol are coming to the fore in the clinical trials of one of the vaccines approved for inoculation in the country. ....

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No consent, no follow-up, claim Bhopal gas tragedy victims in COVID vaccine trial

No consent, no follow-up, claim Bhopal gas tragedy victims in COVID vaccine trial
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No consent, no follow-up, claim Bhopal gas tragedy victims in vax trial

No consent, no follow-up, claim Bhopal gas tragedy victims in vax trial
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Covaxin row: Bharat Biotech clarifies allegations over volunteer who died after shot

ANI |
Updated: Jan 09, 2021 20:24 IST
New Delhi [India], January 9 (ANI): After a participant who allegedly died days after volunteering for Covaxin trial in Bhopal, Bharat Biotech on Saturday clarified that the volunteer, at the time of enrolment, had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase III trial and was reported to be healthy in all the site follow up calls post seven days of his dosing.
With regard to reports of a death in Phase III trials, we would like to state that a volunteer passed away on December 21, 2020, and the death was reported to the People s College of Medical Sciences and Research Centre by the son of the deceased, Bharat Biotech stated. ....

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