Man claims vaccine trials lead to neurological disorders; SII refutes claims and seeks damages worth 100 crore

According to a PTI report, a 40-year-old man has sought ₹5 crore compensation in a legal notice to the Serum Institute of India and others, while also seeking a halt to the trial. This man has alleged that he has suffered serious side effects, which includes a virtual neurological breakdown and impairment of cognitive functions after he took part in the ‘Covishield’ vaccine trial in Chennai.

On Sunday, the Vaccine manufacturing major dismissed claims that a volunteer of the trials of the Covid-19 vaccine which is under development in its facilities had serious side effects, and had threatened to seek heavy damages for “malicious” allegations.

The Serum Institute of India in a statement said that “Serum Institute of India is sympathetic with the volunteer’s medical condition, there’s absolutely no correlation with vaccine trial and his medical condition. He’s falsely laying blame for his medical problems on trial.”

“The claim is malicious because the volunteer was specifically informed by the medical team that complications he suffered were independent of vaccine trial he underwent. Despite specifically being made aware of the same, he still chose to go public and malign reputation of company,” the vaccine developer said in a statement.

It also said that the volunteer is falsely laying the blame of his health problems on the COVID vaccine trial, which are supposedly caused by his own medical conditions.

“It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive,” they said. The Serum Institute of India, also added that it will seek the damages in excess of 100 crores and will also defend against such malicious claims

The participant has sought for cancelling approval for the testing of the vaccine, and also of ‘manufacture and distribution’, failing which legal action would be taken, according to PTI.

Along with SII, a legal notice has also been served to The Indian Council of Medical Research (ICMR), one of the sponsors as well as to Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man.

The notice stated that the man, following the vaccination, has suffered acute encephalopathy, damage or disease that affects the brain, and all his tests confirmed that his deteriorated health was due to the test vaccine. The notice also claimed that the vaccine was not safe as made out to be because the trauma he underwent after taking it ‘cleary proves’ that. And also all the stakeholders were trying to hide the adverse effect that the vaccine has had on him.

It also said that after a psychiatric evaluation, a mild deficiency in the verbal and visual memory functions has been seen and an under-functioning in overall cognitive functions has also been detected. “The vaccine had led to a virtual neurological breakdown in him and he has gone through extreme sufferings, both neurologically and psychologically,” the notice claims.

The notice also said the man would have no other option except to take legal action against all the concerned parties if they fail to immediately stop the testing, manufacturing and the distribution of the vaccine. The Drugs Controller General of India and other institutional ethics committees are investigating whether the event of the alleged claims said to have been suffered by a COVID-19 vaccine trial participant is related to the shot administered to him.

Serum Institute of India (SII), which is based in Pune, has collaborated with Oxford University and Astra Zeneca, a pharmaceutical company for making the COVID-19 vaccine, ‘Covidshield’, and is conducting trials in India.