- The man claimed to suffer neurological breakdown after taking a dose
- Serum Institute said no correlation with trial and the medical condition
- The allegations are malicious and misconceived, it said
The Serum Institute of India, responding to what it calls "malicious and misconceived" allegations, has said it will file a Rs 100 crore defamation suit against a Covishield coronavirus vaccine trial participant who claimed to suffer a "virtual neurological breakdown" after being administered a dose.
In a statement to NDTV on Sunday evening, the Serum Institute said that while it sympathised with the volunteer's medical condition there was "absolutely no correlation with the vaccine trial and the medical condition of the volunteer".
"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 medical problems on the COVID vaccine trial," the statement said.
"The claim is malicious because 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 statement added.
The Serum Institute said it would seek at least Rs 100 crore in damages and would continue to defend itself from all such claims.
A 40-year-old Chennai man, who was a volunteer for the third phase of the Covid vaccine trial conducted by the Serum Institute, has claimed Rs 5 crore as compensation for "a serious adverse event after being administered the under-trial vaccine".
He was administered the dose at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER) on October 1.
According to his legal notice, which was filed November 21, ten days later he began experiencing "severe headaches", "total behavioural change" and "irritation towards light and sound". Subsequently, the notice claims, he could not recognise or speak to anyone.
On October 26 he was discharged from hospital after suffering from "Acute Encephalopathy" that, the notice claims, was "an extreme side effect of the test vaccine..."
The notice also cites what it says is an extract from the trial's "Participant Information Sheet (PIS)", which says: "This vaccine has been previously tested in around 500 health(y) adults of 18 to 55 years of age in (the) United Kingdom (U.K) and was found to be safe".
This, the notice says, "led (the man) to believe that taking the Covishield test vaccine was safe and the risks associated with taking the said vaccine would hardly lead to any serious side-effect".
The Sri Ramachandra Institute, which has also been named in the notice, said "no comment" was its formal response at this stage.
However, sources in the institute said it had a role in Phase 2 and Phase 3 trials and all information on the patient's condition had been shared with other trial sponsors in accordance with protocol.
The Drugs Controller General of India (DCGI) and an ethics committee at the Sri Ramachandra Institute will investigate the man's claim, a report by news agency PTI said.
The Covishield vaccine is among the more promising candidates in latter stages of testing around the world. On Saturday evening SII CEO Adar Poonawalla, after meeting Prime Minister Narendra Modi, said the company would apply for an emergency use license for Covishield.
Earlier this week Mr Poonawalla told NDTV that a minimum of 100 million doses would be available by January and hundreds of million by the end of February.
With input from PTI