In Bhopal, Covaxin trial volunteers allege irregularities in recruitment and treatment

A volunteer receives a shot in a trial for Covaxin, a COVID-19 vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, during the Phase three trial at the People's Medical College in Bhopal on 7 December 2020. Sanjeev Gupta/EPA
05 January, 2021

According to several residents in Bhopal, the People’s College of Medical Sciences and Research Centre recruited them to participate in the clinical trial of a COVID-19 vaccine without giving them requisite information. Phase three human trials for Covaxin—a COVID-19 vaccine developed by Bharat Biotech, a vaccine manufacturer in Hyderabad—are underway across India. All the trial participants in Bhopal that The Caravan spoke to mentioned that representatives of the centre had visited their neighbourhoods looking for volunteers. Some of these residents said they were told that they would get Rs 750 for their time and participation. Some said that they were not told that it was a clinical trial or informed of possible side effects. Seven people told me that they reported serious adverse events after participating in the trial. Most of them are from families that struggle financially and live close to the Union Carbide plant, which was the source of a fatal gas leak in 1984. Some of the trial participants are also survivors of this industrial accident.

Among the participants was Jitendra, a 36-year-old resident of Shankar Nagar area. Jitender said he went to the People’s College of Medical Sciences and Research Centre on 10 December 2020. He said that earlier that day, workers from the college had come to his neighbourhood and made an announcement saying that people would be given a vaccine and some money. “At that time, I just knew they were vaccinating people against COVID-19, and will pay each participant Rs 750, so I thought what’s the harm in going? They took care of the commute to and from the hospital as well,” he said. 

When he reached the hospital, he was told that the vaccine being offered was under trial. Jitendra was enrolled in a phase three trial of Covaxin. On 3 January, the Drug Controller General of India, VG Somani, approved Covaxin for “restricted use in emergency situation.” Many public health experts, scientists and activists, questioned this approval as its phase three trial had not been completed and no interim phase three data for it has been published.

While enrolling himself, Jitendra said he informed the trial investigators that he had recently recovered from typhoid and had a persistent cold and cough the past year. The investigators assured him that taking the vaccine was safe. According to him, they said, “Isse khoon saaf hoga, bimari nahi hogi”—This will clean your blood, protect you from the disease. The hospital gave Jitendra an injection which could either be the vaccine or a placebo. The Covaxin phase three trial is  a double-blind and placebo-controlled, which means that neither the participants nor the investigators know who is getting a vaccine dose and who is getting a placebo till the trial is unmasked at a later stage for analysis. According to the trial protocol uploaded on the Clinical Trial Registry of India, the Covaxin phase 3 trial aims to enroll 25,800 people randomly divided into the placebo and vaccine groups.