Questions over India’s Covaxin side effects, ethical violations Quartz 1/12/2021
A shadow is lurking over the trial process of India’s homegrown Covid-19 vaccine.
Covaxin, the novel coronavirus vaccine co-developed by Bharat Biotech and the Indian Council for Medical Research, has been accused by some trial participants of sidestepping procedures and not making adverse events public. It has denied these charges, but trial volunteers want the government to intervene and halt the phase 3 human trials.
Bharat Biotech began courting controversy on On Jan. 4, when scientists expressed grave concerns over the hasty approval given to Covaxin. Now, its trial participants in Madhya Pradesh’s Bhopal allege that they were not informed that the jab would be given to them as part of a clinical trial. Covaxin’s third phase of human trials has 25,800 participants across the country.
Updated:
January 13, 2021 12:03 IST
A failure to investigate the conduct of the recent Covaxin phase-3 trial can affect the course of other studies under way
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A failure to investigate the conduct of the recent Covaxin phase-3 trial can affect the course of other studies under way
More than a decade since the human clinical trial of the human papilloma virus (HPV) vaccine it was controversial and carried out without proper consent on nearly 23,500 girls in the 10-14 age group in Vadodara, Gujarat and Khammam district of Andhra Pradesh and eight years after the Supreme Court of India slammed the government for slipping into “deep slumber” in addressing the “menace” of illegal clinical trials carried out in India by multinational countries, nothing much seems to have changed.
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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.