Halt Covaxin trials, say health groups; seek probe into ‘ethical violations’

Five days after four organizations representing survivors of Bhopal gas disaster wrote to the Prime Minister seeking an immediate halt to the trials of indigenous COVID-19 vaccine Covaxin, multiple health groups have called for an investigation into allegations of ethical violations during a clinical trial of the vaccine.

Covaxin has been developed by India’s Bharat Biotech and the Indian Council of Medical Research.

In a statement released on January 14, groups of doctors and health rights advocates have asked the government to halt the trial at the People’s Hospital in Bhopal, exclude any data from the site during trial analysis, and take action against those responsible for violations.

The Bharat Biotech vaccine is one of the two COVID-19 vaccines granted accelerated approval by India’s drug regulatory authority for restricted emergency use, relying on safety and immunogenicity data without efficacy data.

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India has also approved the Oxford Astra Zeneca vaccine, after reviewing safety, immunogenicity, and efficacy data from outside India and safety and immunogenicity data in India. A trial to evaluate the efficacy of the Bharat Biotech vaccine has enrolled 25 800 participants at 25 sites in 12 cities.

According to the four organizations, many people affected by the Union Carbide gas disaster in Bhopal and by contaminated water were recruited into the trial in violation of ethical procedures established under the law. Some of these individuals have faced adverse events since the dosage, and even a death has taken place, they alleged.

Signatories on the health groups’ statement have said they are concerned about the government’s silence on the allegations and the death of a participant at the site on December 21.

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The hospital and Bharat Biotech have said a review and a post-mortem had found that the participant had died from poisoning and police are investigating the death. The company has asserted that the death had no connection with the vaccine.

Bharat Biotech has said in a statement that the trial is in full compliance with “good clinical practice guidelines and all regulatory provisions that apply to the conduct of clinical trials in India”.

The government has ordered 11 million doses of the Oxford AstraZeneca vaccine, manufactured by the Serum Institute of India, and 5.5 million doses of the Bharat Biotech vaccine, to start a campaign to vaccinate around 3 crore healthcare workers on January 16.