Activists write to PM Modi on unethical practices at Covaxin s Bhopal trial site
Premium
Bhopal: A medic administers Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), during the Phase- 3 trials at Peoples College of Medical Sciences & Research Centre in Bhopal.
(PTI)
Bharat Biotech, in its statement, said that the Covaxin Phase 3 study is being conducted across 26 sites in India in compliance with the study protocol, Indian good clinical practice guidelines, and all regulatory provisions that apply to clinical trials in the country
Share Via
Read Full Story
Activists involved with the Bhopal gas tragedy have written to Prime Minister Narendra Modi and health minister Harsh Vardhan about the unethical practices at the clinical trial site for Bharat Biotech s Covaxin at the city’s Peoples College of Medical Sciences & Research Centre.
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.
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.
The case comes amid concerns being raised by industry experts and opposition parties on the emergency approval granted to Bharat Biotech s coronavirus vaccine ‘Covaxin without publication of efficacy data. The Phase III clinical trials are underway.