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.”
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.
At least four NGOs working for the survivors of the 1984 Bhopal gas tragedy on Sunday wrote to Prime Minister Narendra Modi demanding that the ongoing clinical trials for Covaxin, an indigenously developed COVID-19 vaccine, be stopped in the Madhya Pradesh capital in view of the "gross violation of laws and guidelines".
Bhopal Gas Afflicted Organizations Demand Ban on Covaxine Trial, Bhopal News in Hindi khaskhabar.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from khaskhabar.com Daily Mail and Mail on Sunday newspapers.