Bhopal activists demand probe into Covaxin trials incident
January 11, 2021
Allege gross violation of laws governing clinical trials
As the country prepares to roll out two Covid-19 vaccines on a mass scale, a clutch of organisations from Bhopal have written to the Prime Minister and Health Minister on allegations of serious violations in the Phase-3 clinical trials being conducted at the People’s College of Medical Sciences & Research Centre in Bhopal to assess the safety, immunogenicity and efficacy of Covaxin.
Covaxin is the Covid-19 vaccine from Bharat Biotech being developed in collaboration with the Indian Council of Medical Research (ICMR). It was recently approved for restricted use, (along with Serum Institute of India’s vaccine), but in a clinical trial mode - a caveat that had many scientific voices raising concerns on its implications.
Volunteer s death in Bhopal not related to our vaccine: Bharat Biotech PTI
Updated : Jan 10, 2021, 10:06 am IST
The volunteer was reported to be healthy in all the site follow-up calls post seven days of his dosing, the vaccine maker said
There are several factors that can cause an adverse event during a clinical trial, including the patient s underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident, Bharat Biotech said. (Representational Image: AFP)
Volunteer s death in Bhopal not related to our vaccine: Bharat Biotech
New Delhi: Vaccine maker Bharat Biotech on Saturday said the death of a volunteer in Bhopal, who took a shot of its COVID-19 vaccine Covaxin as part of the Phase III clinical trials, was not related to the medication.
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.”
Bhopal organisations ask govt to stop Bharat Biotech COVID-19 vaccine trials; cite norms violation at site
Coronavirus vaccination drive: The letter alleged irregularities and ethical violations in the conduct of the clinical trial of Covaxin by the People s College of Medical Sciences & Research Centre, Bhopal
Joe C Mathew | January 10, 2021 | Updated 15:09 IST
COVID-19 vaccination drive: Bhopal organisations ask for halt in trials
Four organisations representing survivors of the Union Carbide gas disaster in Bhopal have written to Prime Minister Narendra Modi and Health Minister Dr Harsh Vardhan to immediately stop the ongoing clinical trials of Bharat Biotech s COVID-19 vaccine Covaxin in Bhopal.