The Serum Institute of India on Sunday filed a $13 million (Rs100 crore) defamation lawsuit against one of the volunteers who took part in its Covid-19 vaccine trial for falsely claiming that he fell ill after being administered the dose. The volunteer had claimed that he suffered a "virtual neurological breakdown" after being administered a dose of Covishield, which is being developed by the India-based biotech firm.
Serum Institute's decision comes after the volunteer sent a legal notice to the company seeking $676,000 million as compensation after allegedly suffering side effects. The Serum Institute, which manufactures around 30 percent of the all vaccines produced annually across the globe, has partnered with drug manufacturer AstraZeneca and the University of Oxford to produce the Covishield vaccine in India.
Serum Institute Moves Court
In a statement released on Sunday, the Serum Institute said that while it sympathized with the volunteer's medical condition, it is filing a defamation suit against the 40-year-old for trying to tarnish the image of the company and misleading millions of people who are in hope of getting a Covid-19 vaccine at the earliest. The biotech firm said there was "absolutely no correlation with the vaccine trial and the medical condition of the volunteer".
The statement from Serum Institute claimed the man was spreading "malicious information" with "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," it added. The biotech firm further said that the volunteer's motive was spreading malicious information because the moment he complained of uneasiness, the medical team informed him that complications he suffered were independent of the vaccine trial he underwent. However, he continued to spread the misinformation.
What Exactly Happened
The volunteer was administered a dose of Covishield in the third phase of the Covid vaccine trial at Chennai's Sri Ramachandra Institute of Higher Education and Research on October 1. He then claimed to have suffered "virtual neurological breakdown" and demanded that the vaccine trial be immediately halted.
Moreover, he demanded Serum Institute to immediately suspend all its manufacturing and distribution plans, failing which he would take legal action. He was then treated for over three weeks in the hospital and discharged on October 26.
Following that he then sent a legal notice on November 21 seeking $676,000 as compensation for "a serious adverse event after being administered the under-trial vaccine". According to the legal notice, there was a total "behavioural change" in the participant and he seemed unaware of his surroundings.
The notice further claims that no public disclosure about the incident was made even after the participant reported his condition. The new controversy comes at a time when doubts have been raised about the vaccine after AstraZeneca and Oxford University acknowledged a manufacturing error.
Prior to that Serum Institute had halted its trials in India in September following an "unexplained illness" in one of the volunteers. However, Serum Institute in its lawsuit mentions that the volunteer's claims are with an ulterior motive and can damage the development of the vaccine.
The Covishield vaccine is among the more promising candidates in the latter stages of testing around the world. Moreover, the vaccine has raised hopes for many developing countries because of its relatively cheaper price and ability to be transported and stored at normal temperatures.
On Saturday evening Serum Institute's CEO Adar Poonawalla, after meeting with India's Prime Minister Narendra Modi, said the company would apply for an emergency use license for Covishield.