SII to sue man over claims of Covishield side effects

Serum Institute of India (SII), the world’s largest vaccine maker, said on Sunday that it plans to file a lawsuit seeking Rs 100 crore from a 40-year-old man who has demanded that the company pay him Rs 5 crore, claiming that he had developed serious side-effects in the human trials that the company conducted on the coronavirus disease (Covid-19) vaccine candidate Covishield.

The man has served a legal notice on Pune-based SII, claiming to have suffered a virtual neurological breakdown and impairment of cognitive functions, seeking Rs 5 crore in compensation and a halt to the trial.

“The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medial problems on the Covid vaccine trial,” a SII spokesperson said.

“The volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company... the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India will seek damages in excess of Rs 100 crore for the same and will defend such malicious claims,” the spokesperson added.

The legal notice has been sent to SII, which has collaborated with Oxford University and Astra Zeneca Plc in testing Covishield, the vaccine candidate they developed, the Indian Council of Medical Research, one of the sponsors, and Chennai-based Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man.

Alleging that the candidate vaccine was not safe, the man who participated in the trial has also sought cancellation of the approval for its testing, manufacture and distribution, failing which, he said, legal action would be taken. The man, according to the notice, suffered acute encephalopathy, a disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was because of the vaccine candidate.

When contacted, a spokesperson for Sri Ramachandra Institute of Higher Education and Research said the institute had received the notice, but declined to elaborate.

According to the legal notice, the information provided in the Participant Information Sheet (PIS) was absolutely certain that Covishield was safe and the man was hence led to believe the claim and sign up for the trial. He was administered the vaccine candidate on October 1. Although there were no side effects for the first 10 days, he subsequently had episodes like a severe headache and vomiting.

The Drugs Controller General of India (DCGI) and the institutional ethics committee at the implementation site are investigating the adverse event. The DCGI declined to respond to the matter.

A senior health ministry official said: all trial subjects across the world have to sign an “informed consent form”, before they undergo any clinical trial. This form also mentions illustrative instances of adverse events that may occur. The trial participant had signed a consent form. A senior faculty member at the institute who did not wish to be named said that the patient was admitted following complaints of a headache. “At the time of discharge, he did not have any major effects or neurological deficits and there was no basis to link the vaccine as the cause,” the senior doctor said, requesting anonymity. “He refused to take the second dose.”

The hospital discharge summary accessed by HT states that he was recovering from acute encephalopathy (that alters brain function) with a diagnosis of vitamin D and B12 deficiency.

The institute said that all regulatory bodies for the independent clinical trial such as the ICMR, Serum Institute and Central Drug Standard Control Organisation and the ethics committee of the trial were informed. “We are currently preparing our legal response.”

Repeated calls and messages to the principal investigator of the trial, Dr S R Ramakrishnan, and the vice chancellor, Sri Ramachandra Institute of Higher Education and Research, Dr P V Vijayaraghavan went unanswered. The institute has been conducting two trials-- on Covishield, developed by Oxford University/ Astra Zeneca and is being produced in a Pune laboratory and Covaxin, developed by Hyderabad-based Bharat Biotech International Limited.

ICMR has also picked SRM Medical College Hospital and Research Centre in Chennai as one of its clinical trial sites for Covid-19 vaccines. Besides that, the state government is in the second phase of tests on Covishield which is nearing completion. “So far there have been no adverse reactions or events in candidates in the first and second doses that were given,” said Dr T S Selvavinayagam, director, directorate of public health and preventive medicine. “We will start trials for Covaxin soon.”