The Serum Institute of India on Sunday (November 20, 2020) filed a Rs. 100 crore defamation suit against a Chennai-based volunteer who took part in their COVID-19 vaccine trial and alleged that it triggered an adverse reaction and suffer a neurological breakdown after taking a dose.

Serum Institute has partnered with drug manufacturer Astra Zeneca and the University of Oxford to produce the Covishield vaccine in the country. The vaccine is seen as a possible option for many developing countries because of its cheaper price and ability to be transported and stored at normal temperatures.

The volunteer aged 40 years sought Rs. 5 crores from Serum Institute citing side effects of virtual neurological breakdown and impairment of cognitive functions after taking the dose of the Covid shot. However, the Serum Institute denied the allegations and called them “malicious” and “misconceived”. 

He also sent a legal notice to ICMR, DCGI, AstraZeneca, and Oxford University to stop testing, manufacturing, and distributing vaccines. In the legal notice, he claims that he experienced headaches and then endured a seven-day stay in the intensive care unit (ICU). ​

We haven’t received any response from any of the parties to whom we have sent the notice. We will be left with no other option but to go ahead and file a writ petition and get ready for a legal battle,” advocate R. Rajaram, on behalf of the Volunteer said.

In a statement, a Serum Institute spokesperson said that while it sympathized with the volunteer's medical condition there was "absolutely no correlation with the vaccine trial and the medical condition of the volunteer"

Further, it is added that, “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,” the statement said. “The volunteer is falsely laying the blame for his medical problems on the Covid vaccine trial. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company.”

"It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India will seek damages in excess of 100 crores for the same and will defend such malicious claims," Serum Institute said. 

As per experts, Serum Institute is performing bad moves as they initiated a Counter defamation suit against the Volunteer. 

Bioethics expert Professor Anant Bhan reacted on Twitter saying that the move on Serum Institute’s part is to browbeat the volunteer. "A bad move by Serum to counter-sue. Volunteers participate in studies mostly out for altruistic reasons. In this case, healthy volunteers. If there is an issue about the serious adverse event (SAE), better to engage with the participant to understand their concerns. Rather than try to browbeat them," he said.

The All India Drug Action Network (AIDAN) also added by saying that "This ( the defamation suit) is a blatant attempt of intimidation”.