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“No way induced by vaccine”- SII on trial volunteer’s “extreme adverse effects” claim

Amidst the ongoing controversy pertaining to a volunteer’s allegations on the AstraZeneca vaccine candidate, the drugmaker today said reiterated that its prevention shot is “safe and immunogenic”.

Opposing the trial volunteer’s complaint of the vaccine showing adverse effects in his body including “virtual neurological breakdown, memory loss and behavioural changes”, Serum Institute of India’s chief Adar Poonawala spoke about the legal action the company is taking against the Chennai man in order to maintain the reputation of the business house that is becoming the centre of negative attention.

At a time when the drug is about to receive its emergency use license for release in the market post all trials, complaints from a trial volunteer himself raises thousands of questions regarding the vaccine’s reliability and safety.

As such, the company said that the sue notice sent to the man will act as a medium to “safeguard the reputation of the company which is being unfairly maligned.”

While calling the accusations as “malicious and misconceived”, the drugmaker is directing its lawyers to file a defamation lawsuit against the volunteer of Rs.100 crore. Experts believe that the attempt is a way to intimidate the participant to withdraw the case.

Further terming the reactions and sudden changed health condition of the man as nothing caused by the vaccine, Serum Institute of India stated, “The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteers, though highly unfortunate, was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer’s medical condition.

The company said the Principal Investigator of the Data and Safety Monitoring Board and the Ethics Committee had “independently cleared and reckoned it as a non-related issue to the vaccine trial”.

Mr. Poonawalla in his statement also said that as the vaccine won’t be administered to the population without the stamps of its complete safety and immunogenicity, the legal notice to the participant is a way to discard the existing confusions regarding the vaccine and also to withhold the company’s esteem as it is on stake.

The whole ruckus started when a 40-year-old man, belonging to the southern city of Chennai, who also took part in the covid-19 trials for the Oxford vaccine in its third phase, alleged that he suffered a “serious adverse event after being administered the under-trial vaccine”. For the shot administered to him on October 1st, the volunteer demanded a sum of Rs.5 crore as compensation towards the ill-effects bore by him.

In his November 21st notice, he alleged that after a span of 10 days of getting the dose, he started getting “severe headaches” along with “total behavioural change” and “irritation towards light and sound”. Apart from this, he claimed in the legal complaint, that his condition worsened to the extent that he had lost his recognition and speech abilities.

The notice further alleges that he was discharged on October 26th from the hospital where he was told to be suffering from “Acute Encephalopathy”, apparently “an extreme side effect of the test vaccine”.

The Serum Institute of India is prepping to send a defamation suit to him for falsely accusing the vaccine of being the causative factor for his medical issue.