COVID-19: Vaccine Trial Volunteer Seeks Rs 5-Cr Compensation Alleging Side Effects, Serum Institute Junks Claims
The Serum Institute of India (SII) rejected the charges brought by Chennai-based man who volunteered to take part in clinical trials of vaccine candidate Covidshield and plans to seek damages in excess of Rs 100 crore.
The 40-year-old participant had alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial. The vaccine major called the allegations “malicious”.
"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. The volunteer in the notice called for the cancellation of testing, manufacturing and the distribution of the vaccine immediately, failing which he said he has no other option except to take appropriate legal action against all the concerned parties. Per the legal notice, the volunteer alleged that his brain has been affected by the vaccine dose. A psychiatric evaluation revealed mild deficit in verbal and visual memory functions, as a side effect of the vaccine. “He has gone through extreme sufferings, both neurologically and psychologically. The vaccine had led to a virtual neurological breakdown in him,” the evaluation said. The trial volunteer was informed through a ‘Participant Information Sheet (PIS)’ that the 'Covishield' vaccine developed by Oxford University is safe. After this, the man gave his consent as a volunteer on 29 September. On October 1, he was administered the first dose of vaccine and no side effects were revealed in the first 10 days. However, later he had episodes of severe headaches and vomiting. On 11 October, the man was admitted to Ramachandra Hospital, where his family members alleged that he showed behavioural changes. The Serum Institute is developing COVID-19 vaccine in collaboration with Oxford University and pharmaceutical company Astra Zeneca. Along with the Serum Institute, the Indian Council of Medical Research and the Sri Ramachandra Institute of Higher Education and Research are also involved in the vaccine development effort.
"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. The volunteer in the notice called for the cancellation of testing, manufacturing and the distribution of the vaccine immediately, failing which he said he has no other option except to take appropriate legal action against all the concerned parties. Per the legal notice, the volunteer alleged that his brain has been affected by the vaccine dose. A psychiatric evaluation revealed mild deficit in verbal and visual memory functions, as a side effect of the vaccine. “He has gone through extreme sufferings, both neurologically and psychologically. The vaccine had led to a virtual neurological breakdown in him,” the evaluation said. The trial volunteer was informed through a ‘Participant Information Sheet (PIS)’ that the 'Covishield' vaccine developed by Oxford University is safe. After this, the man gave his consent as a volunteer on 29 September. On October 1, he was administered the first dose of vaccine and no side effects were revealed in the first 10 days. However, later he had episodes of severe headaches and vomiting. On 11 October, the man was admitted to Ramachandra Hospital, where his family members alleged that he showed behavioural changes. The Serum Institute is developing COVID-19 vaccine in collaboration with Oxford University and pharmaceutical company Astra Zeneca. Along with the Serum Institute, the Indian Council of Medical Research and the Sri Ramachandra Institute of Higher Education and Research are also involved in the vaccine development effort.
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