Participant in Serum Institute's COVID Vaccine Trial Alleges Side Effects, Seeks ₹5 Cr Compensation
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Tamil Nadu, 29 Nov 2020 10:57 AM GMT | Updated 29 Nov 2020 11:06 AM GMTcheck update history
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The participant has been diagnosed with "acute neuro encephalopathy", which has allegedly been linked as a side-effect of the Covishield shots.
A Chennai-based man has demanded compensation of Rs 5 crores from Pune-based drugmaker Serum Institute of India (SII) as his health worsened after volunteering to take part in the clinical trials for a Covid-19 vaccine. On his behalf, a law firm has sent a legal notice to SII.
The vaccine 'Covishield' is being developed by the University of Oxford University and pharma giant AstraZeneca. The manufacturing partner for the vaccine is SII which is expected to prepare a million doses.
The third phase of the human trial for the vaccine in which the Chennai man participated took place at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER).
The CEO of Serum Institute of India (SSI), the Drugs Controller General of India (DGCI), AstraZeneca, and the vice-chancellor of SRIHER received the legal notice.
According to the notice, after the participant took the vaccine on 1st October, he has been diagnosed with "acute neuro encephalopathy", which has allegedly been linked as a side-effect of the Covishield shots. He was informed that he was participating in a randomised controlled study to determine the safety of the Covid-19 vaccine.
The legal notice claims the participant began experiencing headaches and then endured a seven-day stay in the intensive care unit (ICU).
According to the discharge summary of the hospital, he was brought "in an altered mental state" and was "disoriented". He was finally discharged from the hospital on October 26.
The volunteer's wife claims that the situation has not improved much and he continued to be in an unstable mood. Finally, he has to visit a psychiatrist.
In the notice, it was also alleged that even after a month of the severe adverse reactions to the vaccine, neither have the regulator (Drugs Controller General of India/ Data and Safety Monitoring Committee), the sponsors of the trial (ICMR and SII) or the collaborators of the sponsors (Astra Zneca and OXford University) contacted him to find about the severe adverse effects that he had been experiencing after he took the vaccine.
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