- The Chennai based participant for the Covid-19 vaccine allegedly suffered serious neurological and psychological symptoms after taking the experimental shots.
- The Serum Institute said, the volunteer is falsely laying the blame for his medical problems on the vaccine trial.
- The Institute called the accusation malicious and misconceived.
On Sunday, the Serum Institute of India filed a Rs 100 crore defamation lawsuit against a volunteer-based in Chennai who participated in their coronavirus vaccine study and alleged that it induced an adverse reaction, including neurological impairment.
The Serum Institute has collaborated with drug manufacturer AstraZeneca and Oxford University to develop the country’s Covishield vaccine. Due to its lower price and ability to be shipped and stored at normal temperatures, the vaccine is seen as a potential choice for many developing countries.
On November 21, the volunteer sent out a legal notice and sued the Serum Institute for Rs 5 crore. The firm denied the accusations, however and called them “malicious” and “misconceived.” The Serum Institute spokesperson said in a statement that while they sympathized with the medical condition of the volunteer, there was “absolutely no correlation with the vaccine trial and the volunteer’s medical condition.”
“The claim is called malicious & misconceived because the medical staff told the volunteer clearly that the complications, he suffered were independent of the vaccine trial he underwent, the statement said. The volunteer is falsely blaming his medical conditions for the Covid vaccine trial. Nevertheless, despite being clearly made aware of it, he decided to go public and malign the organization’s reputation.
The statement stated that the man was disseminating “The declaration claimed the man was spreading ” “The Serum Institute of India, will seek damages of Rs.100 crore and defend such malicious claims,” it added.
On October 1, the volunteer was given a dose of the vaccine at the Sri Ramachandra Institute of Higher Education and Research in Chennai. The Chief Executive of AstraZeneca in the United Kingdom, the Chief Prosecutor of the Oxford Trials and the Vice-Chancellor of the Ramachandra Institute were also sent a copy of his legal notice.
The man called for the immediate halt of the vaccine trial and the suspension of all plans for its “production and distribution,” failing which legal action will be taken. There was a complete “behavioural change” in the participant, according to the legal notice, and he appeared unaware of his environment.
It also noticed that no official statement was made about the incident even after the participant announced his illness. It contrasted this reaction with the Serum Institute’s decision to suspend trials in India following the suspension of AstraZeneca’s clinical trials in September due to an unknown disease in a participant sample.
Institute reports, however, said it had a role in Phase 2 and Phase 3 trials, and all patient condition information was shared in compliance with policy with other trial sponsors.
A report by the news agency PTI said that the Drugs Controller General of India (DCGI) and an ethics committee at the Sri Ramachandra Institute will investigate the man’s claim.
In the later stages of trials around the world, the Covishield vaccine is among the most successful ones. On Saturday evening, following a meeting with Prime Minister Narendra Modi, SII CEO Adar Poonawalla said the company would apply for a Covishield emergency license.