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Serum Institute Files Rs 100 Crore Case Against Volunteer Who Alleged Oxford Vaccine Made Him Ill; Know More
Pune-based Serum Institute has filed a Rs 100 crore case against a volunteer of Oxford University Covishield Vaccine who had alleged severe side effects after taking the shot.
New Delhi: Pune-based Serum Institute of India has countered the allegations of side effects made by a volunteer of Oxford University Covid-19 vaccine with a Rs 100 crore case for damage to its reputation. SII had rejected the charges by the participant as "malicious and misconceived" and had said that 'there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer.'
This comes after a 40-year-old business consultant from Chennai who was a volunteer of Covishield vaccine trials is being conducted by SII alleged that he suffered a neurological breakdown and impairment of cognitive functions due to the vaccine and according to a report by PTI, the Drugs Controller General of India (DGCI) and the institutional ethics committee are now investigating the matter.
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What has the participant alleged?
The report says that the man was administered the shot at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1. He has said that for 10 days there were no but subsequently, he suffered episodes of severe headache and vomiting.
According to the legal notice, he decided to become a volunteer as he believed in the information provided in the 'Participant Information Sheet (PIS)' which said that Covishield, the vaccine developed by Oxford University, is safe. His wife has said in the legal notice that he showed behavioural changes.
'He could neither recognise anyone nor speak and was totally disoriented and was shifted to the ICU and was on October 26 "discharged at our (family's) request. At home, he seemed quite disoriented at times and was unable to relate to things or work. He would not have volunteered for the test vaccine if all the potential risk factors of the test vaccine had been known to him, the notice given on November 21 said.' A legal notice has been sent to Director General of ICMR, CEO, Serum Institute of India Private Limited, Pune, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator of Oxford Vaccine Trial and Vice-Chancellor of Sri Ramachandra Higher Education and Research.
SII rejects charges
SII has and said it will seek damages in excess of Rs 100 crore. "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," it 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," Serum Institute said.
It has to be noted that AstraZeneca that is collaborating with Oxford University for Covid-19 vaccine has temporarily paused trials of the vaccine in September after a participant had fallen ill. Trials were later resumed after it was considered safe.
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