IBS to sue man over Covishield side effect claims
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 had developed serious side effects in human trials the company conducted on the coronavirus disease (Covid-19) candidate vaccine Covishield.
The man has delivered a legal notice to Pune-based SII, claiming to have suffered a virtual neurological collapse and impaired cognitive functions, seeking compensation of Rs 5 million and suspension of the trial.
“The accusations in the ad are malicious and ill-conceived. While the Serum Institute of India is sympathetic to the medical condition of the volunteer, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer falsely blames his medical problems on the Covid vaccine trial, ”said an SII spokesperson.
“The medical team specifically informed the volunteer that the complications he suffered were independent of the vaccine test he went through. Despite being specifically informed of the same, he chose to go public and smear the reputation of the company … the intention behind spreading such malicious information is an oblique pecuniary motive. The Serum Institute of India will seek damages in excess of Rs 100 million 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 on the Covishield trials, the candidate vaccine they developed, the Indian Council for Medical Research, one of the sponsors, and the Institute of Studies Chennai-based Senior Sri Ramachandra Education and Research, who administered the vaccine to the man.
Claiming that the candidate vaccine was not safe, the man who participated in the trial also requested cancellation of approval for its testing, manufacture and distribution, otherwise, he said, legal action would be taken. The man, according to the notice, suffered from acute encephalopathy, a disease that affects the brain, after vaccination and all tests confirmed that the setback in his health was due to the candidate vaccine.
When contacted, a spokesman for the Sri Ramachandra Institute for 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 therefore the man was made to believe the claim and register for the trial. The candidate vaccine was administered on October 1. Although there were no side effects for the first 10 days, she subsequently had episodes such as a severe headache and vomiting.
The Comptroller General of Drugs 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 around the world must sign an “informed consent form” before undergoing any clinical trial. This form also lists illustrative cases of adverse events that may occur. The trial participant had signed a consent form. A senior faculty member of the institute who did not want to be named said the patient was admitted for headache complaints. “At the time of discharge, he had no major effect or neurological deficit and there was no basis to link the vaccine as the cause,” said the main physician, requesting anonymity. “He refused to take the second dose.”
The summary of the hospital discharge to which HT had access indicates that he was recovering from acute encephalopathy (which impairs brain function) with a diagnosis of vitamin D and B12 deficiency.
The institute said that all regulatory bodies of the independent clinical trial, such as the ICMR, the Serum Institute, and the Central Organization for Drug Standards Control and the trial’s ethics committee were informed. “We are currently preparing our legal response.”
Repeated calls and messages to the trial’s principal investigator, Dr. SR Ramakrishnan, and to the vice chancellor of the Sri Ramachandra Institute of Higher Education and Research, Dr. PV Vijayaraghavan, went unanswered. The institute has been running two trials: in Covishield, developed by the University of Oxford / Astra Zeneca and it is being produced in a laboratory in Pune and Covaxin, developed by Hyderabad-based Bharat Biotech International Limited.
ICMR has also chosen the SRM Medical College Hospital and Research Center in Chennai as one of its clinical trial sites for Covid-19 vaccines. On top of that, the state government is in the second phase of testing in Covishield, which is nearing completion. “So far there have been no adverse reactions or events in the candidates in the first and second doses they were given,” said Dr. TS Selvavinayagam, director of the directorate of public health and preventive medicine. “We will soon start testing Covaxin.”