Chennai volunteer hits back at Serum Institute says, company is intimidating him
Chennai: The 40-year old volunteer, who works as a business consultant had wanted to investigate the cause of him contracting severe neurological health complications he had suffered after being vaccinated with Covidshield shots under development at Serum Institute of India, but the company was intimidating him with a threat of over Rs 100 crore damage suit, said his advocates.
“We are yet to get any reply for the legal notice sent to various parties, including Serum Institute. We have seen news reports about Serum Institute threatening our client with a suit for over Rs 100 crore,” N.G.R. Prasad, Advocate, Row & Reddy, told IANS.
“Our client had restricted his claim only for Rs 5 crore and wanted investigation to start as to the cause of him suffering severe neurological problems and stop the vaccine from affecting other people,” Prasad added.
On the other hand, Serum Institute without getting into the root cause is intimidating it’s volunteers with a threat of over Rs 100 crore damage suit. “The client is ready to fight it out legally if needed,” R.Rajaram, another Advocate for the volunteer told IANS.
The two advocates said this will be a medico-legal case and the evidence of medical professionals will be obtained in support of their client.
“The volunteer was a healthy male prior to being vaccinated. He was tested only for coronavirus infection before being vaccinated with Covidshield. He was found negative for coronavirus infection,” Prasad said.
“No other medical tests were done to ascertain his health condition,” Prasad added. He said in case of any adverse reaction, investigation into the issue should have been carried out immediately-whether it is related to the vaccine or not.”But it was not done despite the severe neurological health complications our client had developed,” Prasad said.
Reacting to the volunteer’s legal notice, Serum Institute in a media statement on November 29 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.”
“We had sent a legal notice to the Serum Institute; Indian Council for Medical Research (ICMR); AstraZeneca, UK; Drugs Controller General of India; Andrew Pollard, Chief Investigator, Oxford Vaccine Trial; The Jenner Institute Laboratories, University of Oxford; and the Vice Chancellor of Sri Ramachandra Higher Education and Research,” Prasad said.
As per the legal notice issued, the volunteer, a 40-year old male is married and has two kids aged about 12 and 7 years.On coming to know about the call for volunteers for the third phase of human trial at Sri Ramachandra Institute of Higher Education and Research (formerly called Sri Ramachandra Medical College & Research Institute or SRMC) for testing the Covid-19 vaccine developed by the Oxford University, the public spirit in him wanted to volunteer, the notice said.
The volunteer was informed by the Ramachandra Institute that it was a randomised controlled study to determine the safety and immunogenicity of Covishield (Covid-19 vaccine) in the health of Indian adults.The ‘participant information sheet’ given to him said that the sponsors were (a) Serum Institute of India Pvt Ltd (SII), and (b) The Indian Council of Medical Research (ICMR); and the investigation site is Sri Ramachandra Higher Education and Research (deemed university), Chennai, and the investigator is S.R. Ramakrishnan.
According to the notice, the Sri Ramachandra Institute and the trial investigator also assured the volunteer that the vaccine has already been found to be safe and that this study is to further confirm the safety and immune response of Covishield in Indian adults.
“Our client further states that the contents in Page 8 of the participant information sheet further assured the safety of the vaccine, though two participants in the UK developed unexplained neurological symptoms that were concluded to be not related to the vaccine,” the notice stated.
When contacted, a spokesperson of Sri Ramachandra Higher Education told IANS that the matter is subjudice and cannot comment on the matter despite no suit has been filed by the volunteer.(Venkatachari Jagannathan can be contacted at [email protected])–IANSvj/dpb
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