The Pune-based Serum Institute of India (SII) that is gearing up for the mass-production and supply of its COVID-19 vaccine candidate ‘Covishield’ has said that it will sue a participant of its vaccine trial with Rs 100 crore defamation suit for leveling malicious and misconceived allegations.
Notably, a 40-year-old Chennai man, who was a volunteer for the third phase of the COVID-19 vaccine trial conducted by the Serum Institute, has claimed ₹ 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 dated 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…”
Serum Institute refuses claim
SII has refused the claim made by the man. It said that there was no correlation with the vaccine trial and the medical condition of the volunteer.
The company in a statement said: “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 added, “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.”
Jointly developed by AstraZeneca and the University of Oxford, it is one of the cheapest available options for developing countries such as India. Also, the vaccine has an advantage that it can be stored and transported at fridge temperatures.
However, its efficacy ranges between 62 per cent and up to 90 per cent as per the interim results of phase 3 trials. Experts have raised several questions on the manner in which the results have been derived by the company.
To read the latest news in Gujarati click here