Updated: November 29, 2020 5:43:01 pm
The man, he alleged, suffered from acute encephalopathy, damage or disease that affects the brain, after vaccination and all tests confirmed that the setback in his health was due to the test vaccine.
A 40-year-old man who took part in the ‘Covidshield’ vaccine trial here has alleged serious side effects, including a virtual neurological collapse and impaired cognitive functions, and has requested compensation of five million rupees in a legal notice to the Serum Institute and others, in addition to seeking a halt to the trial.
Claiming that the candidate vaccine was not safe, it also requested cancellation of approval for its testing, “manufacture and distribution”, otherwise legal action would be taken.
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The legal notice has been sent to the Pune-based Serum Institute of India (SII), which has collaborated with Oxford University and Astra Zeneca, a pharmaceutical company, in connection with the manufacture of the vaccine, ‘Covidshield’.
The Indian Council for Medical Research, one of the sponsors in addition to SII, and the Sri Ramachandra Institute for Higher Education and Research, which administered the vaccine to the man, received the notification.
The man, he alleged, suffered from acute encephalopathy, damage or disease that affects the brain, after vaccination and all tests confirmed that the setback in his health was due to the test vaccine.
The trauma he suffered after taking it ‘clearly proves’ that the vaccine was not safe as claimed and all stakeholders were trying to hide the adverse effect the vaccine has had on him, according to the advisory.
An electroencephalogram (EEG) test showed that the brain was partially affected (dysfunction involving both hemispheres and the ascending sensory pathways on both sides of both lower extremities).
A psychiatric evaluation revealed mild deficits in visual and verbal memory functions and poor functioning in general cognitive functions, he said.
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“He has been through extreme suffering, both neurological and psychological. The vaccine had caused him a virtual neurological collapse. “
The notice said that it is impossible to “quantify monetarily, the suffering, trauma, pain and humiliation (of hands, legs and body tied and firmly attached to the bed), that he and his family have suffered and are likely to go through for a long time. to come ”.
When contacted, a Ramachandra spokesman said: “We have also received the notice,” but declined to give further details.
According to the legal notice, the information provided in the ‘Participant Information Sheet (PIS)’ was absolutely certain that Covishield, the vaccine developed by the University of Oxford, is safe and therefore the man led him to believe .
Therefore, he decided to become a volunteer and signed the informed consent on September 29 and the result of the coronavirus antibody test came back negative on the same day.
On October 1, they administered the vaccine.
Although there were no side effects for the first 10 days, she subsequently had episodes such as severe headache and vomiting.
A doctor suggested investigations such as a CT scan, as the man did not know what was happening around him and could not answer the questions.
Detailing the sequence of events from October 11 when he was admitted to Ramachandra Hospital and as narrated by the man’s wife, the ad said he showed behavioral changes.
He could not recognize anyone or speak and was totally disoriented and was transferred to the ICU and on October 26, “discharged at our (family’s) request.”
At home, he seemed quite disoriented at times and couldn’t relate to things or work.
You would not have volunteered for the test vaccine if you had known all the potential risk factors for the test vaccine.
But on the other hand, there was a clear assertion of the safety nature of the test vaccine in the PIS that led him to become a volunteer, the notice said.
Legal notice has also been directed to the Comptroller General of Drugs of India, Professor Andrew Pollard, Senior Investigator, Oxford Vaccine Trial, The Jenner Institute Laboratories at the University of Oxford and Astra Zeneca UK.
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