Covishield trial volunteer’s illness highlights gaps in India’s regulations

A medic administers an injection to a volunteer in a COVID-19 vaccine trial in Jaipur, Rajasthan, on 18 December 2020. Vishal Bhatnagar/NurPhoto/Getty Images
07 January, 2021

In October 2020, a 40-year-old man in Chennai who had taken part in a clinical trial for the COVISHIELD vaccine, suddenly fell ill. The COVID-19 vaccine was developed by the Serum Institute of India in partnership with the Swedish-American company AstraZeneca and the University of Oxford. His doctor diagnosed him with encephalopathy, which describes a range of neurological disorders that alter brain function and structure. He slipped in and out of consciousness for four days. Even when he was awake, he was drowsy and disoriented. For a few days, he was unable to talk or recognise anyone around him. “One time he couldn’t even pronounce our children’s names,” his wife told me. On one of the days he was in hospital, a doctor told his wife that he was doing better. “I rushed inside, hoping to see my husband sitting up and smiling at me,” she said. “Instead, I found him lying on the bed and staring at the wall. He glanced at me for a second but couldn’t recognise me.”

The Serum Institute of India based in Pune is conducting trials of COVISHIELD at multiple sites across India. Researchers at the Ramachandra Higher Education and Research Hospital, the site in Chennai, gave the trial participant an injection on 1 October. He started showing neurological symptoms 10 days later. The trial participant, his wife and his doctor believe that the trial dose triggered his symptoms. But the Serum Institute of India said that his illness had nothing to do with the clinical trial. The trial participant and the Serum Institute of India exchanged legal notices. The episode has called into question the company’s and the government’s response in case of complaints about vaccine candidates and approved vaccines. It also highlights the lack of transparency in clinical trials in India and the shortcomings of their regulatory framework. 

On 11 October, the trial participant woke up with a splitting headache and nausea. He slept for most of the day, but when he woke up again he displayed disturbing behavioral changes. He was angry, irritable and unaware of his surroundings. By late evening, he was hospitalized at the Ramachandra Higher Education and Research Hospital where he got the trial dose. He was sedated and put on intravenous fluids. The doctors conducting the trial treated him for 16 days.

The trial participant’s wife told me that the doctors at the trial site and the principal investigator suggested that he might have a vitamin deficiency or an auto-immune disorder that could have caused the reaction. However, their investigations did not find a plausible cause or underlying condition that could trigger encephalopathy. “Whenever I asked what the issue with him might be, what was the cause, they would just tell me I should be happy my husband is recovering,” she said.