Participant in Serum Institute's Covid vaccine trial seeks Rs 5 crore compensation

New Delhi: A law firm representing a 40-year-old participant in the trials of Covishield – the vaccine under development by Pune-based Serum Institute of India (SII) – has sent a legal notice to the company and the drug regulatory authority. Globally, the vaccine technology has been developed by AstraZeneca.
The notice says the participant suffered a serious adverse event after being administered the under-trial vaccine, and is demanding financial compensation of Rs 5 crore. The legal notice also alleges that despite this, no public disclosure was made.

It drew a contrast with SII halting India trials when an adverse event was reported in the UK, when global trials were stopped. Trials resumed after regulatory clearance.

Questions sent by ET to Serum Institute of India, the drug regulatory authority and Indian Council of Medical Research weren’t answered till press time.

Writ Petition Likely
R Rajaram, advocate for the complainant, said they are waiting for the response on the legal notice, which was sent on November 21. “We will file a writ petition in court next week,” he told ET.


The participant, a man from Tamil Nadu, was part of phase 3 trials conducted at Sri Ramachandra Institute of Higher Education and Research, Chennai.

Copies of the legal notice have also been sent to the chief executive of AstraZeneca, UK, chief investigator of the Oxford trials and vice-chancellor of Sri Ramachandra Institute.


SR Ramakrishnan, principal investigator at Sri Ramachandra Institute, said, “An extensive investigation was carried out and we don’t think the adverse event was related to the vaccine. The report was submitted to the Data and Safety Monitoring Board, SII and the drug regulator within the stipulated time.”

He said trials were not halted as they did not receive any such direction either from the sponsor or the drug regulator.

According to the legal notice, a copy of which was reviewed by ET, the participant was “assured” that the vaccine had been found to be “safe,” and the study was to further confirm safety and immune response of Covishield in Indian adults.


“The client was therefore led to believe that taking the Covishield test vaccine was safe and risks associated… would hardly lead to any serious side effect, leave alone severe adverse effect,” said the notice.

According to the Rajaram, what the participant experienced was not even remotely close to what was cited in the participant information sheet. It was stated that the participant might experience “injection site reaction, pain, tenderness, fever, chills, fatigue, headache or joint pain, among other common symptoms.” The advocate also said the information sheet mentioned that there was a rare possibility of severe Covid infection if participants contracted the disease post-vaccination.

According to the notice, the participant received the vaccine on October 1. On October 11, he started experiencing severe headaches and was not able to respond to questions. The participant suffered “acute neuro encephalopathy,” the notice alleges.

The participant was discharged from hospital on October 26. But he “is still not stable, has severe mood swings, problems with comprehension and… (finds it) difficult to do even simple, routine things,” the complaint claims.

The notice further says there has been no follow-up from the hospital, the drug regulatory authority, the company or sponsors.