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Serum Institute rejects charges by Covid-19 vaccine trial participant of ‘serious side effects’

The notice sent to SII alleged that the man suffered acute encephalopathy, damage or disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was due to the test vaccine.

By: Express Web Desk | New Delhi | Updated: November 29, 2020 9:07:45 pm
New phase 2 trial results of Oxford vaccine show success in older peopleThe man, it alleged, suffered acute encephalopathy, damage or disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was due to the test vaccine.

Serum Institute of India, which is testing and manufacturing the Oxford-AstraZeneca Covid-19 vaccine, rejected charges after a 40-year-old man who took part in the trial alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions. Calling the allegations “malicious and misconceived”, Serum Institute threatened to seek damages in excess of Rs 100 crore, PTI reported.

The Pune-based firm’s reaction came after the man sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial. Alleging that the Covishield vaccine was not safe, he has also sought cancelling approval for its testing, “manufacture and distribution”, PTI reported.

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The Indian Council of Medical Research, one of the sponsors besides SII, and Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man, have also been served with the notice.

Reacting to the charges, Serum Institute said in a statement, “The allegations in the notice are malicious and misconceived. 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 further said the volunteer was falsely laying the blame for his medical problems on the vaccine trial. “It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India, will seek damages in excess of Rs 100 crore for the same and will defend such malicious claims,” Serum Institute said.

The notice sent to SII alleged that the man suffered acute encephalopathy, damage or disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was due to the test vaccine.

The trauma he underwent after taking it “cleary proves” that the vaccine was not safe as made out to be and all the stakeholders were trying to hide the adverse effect that the vaccine has had on him, the notice claimed.

An electroencephalogram (EEG) test showed that the brain was affected partially (dysfunction involving both hemispheres and the ascending sensory pathways on both sides from both the lower extremities). A psychiatric evaluation revealed mild deficit in verbal and visual memory functions and an under functioning in overall cognitive functions, it said.

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“He has gone through extreme sufferings, both neurologically and psychologically. The vaccine had led to a virtual neurological breakdown in him,” the notice said.

The man was administered the vaccine on October 1. Though there were no side effects for the first 10 days, he subsequently had episodes like severe headache and vomitting.

Detailing the sequence of events since October 11 when he was admitted to the Ramachandra Hospital and as narrated by the man’s wife, the notice said he showed behavioral 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”, PTI reported

The legal notice has also been addressed to the Drugs Controller General of India, Professor Andrew Pollard, chief investigator, Oxford vaccine trial, The Jenner Institute Laboratories of the University of Oxford and Astra Zeneca UK.

(With PTI inputs)

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