The Serum Institute of India filed a Rs 100 million defamation lawsuit on Sunday against a Chennai-based volunteer who participated in its coronavirus vaccine trial and claimed it triggered an adverse reaction, including neurological deterioration.
Serum Institute has partnered with drug maker AstraZeneca and the University of Oxford to produce the Covishield vaccine in the country. The vaccine is considered a possible option for many developing countries due to its cheaper price and its ability to be transported and stored at normal temperatures.
The volunteer had sent a legal notice on November 21 and sued the Serum Institute for Rs 5 crore. However, the company denied the allegations, calling them “malicious” and “ill-conceived.” In a statement, a spokesperson for the Serum Institute said that while they sympathized with the volunteer’s medical condition, there was “absolutely no correlation with the vaccine trial and the volunteer’s medical condition.”
“The claim is malicious because the medical team specifically informed the volunteer that the complications he suffered were independent of the vaccine test he went through,” the statement said. “The volunteer falsely blames his medical problems on the Covid vaccine trial. Despite being specifically informed of the same, he decided to go public and smear the reputation of the company. “
The statement claimed that the man was disseminating “malicious information” with an “oblique pecuniary” motive. “The Serum Institute of India, will seek damages above [Rs] 100 million rupees for the same and will defend such malicious claims, “he added.
The participant was given a dose of the vaccine at the Sri Ramachandra Institute for Higher Education and Research in Chennai on October 1. Copies of its legal notice were also sent to the UK Executive Director of AstraZeneca, Principal Investigator of the Oxford trials and Vice Chancellor of the Ramachandra Institute.
The man has demanded that the trial of the vaccine be stopped immediately and that all plans for its “manufacture and distribution” be suspended, otherwise legal action would be taken. According to the legal notice, there was a total “behavior change” in the participant and he seemed to be unaware of his surroundings.
“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 that the vaccine had had on him,” the notice said. “He has been through extreme suffering, both biological and psychological. The vaccine had caused him a virtual neurological collapse. ”
He also mentioned that no public disclosure was made about the incident even after the participant reported his condition. Contrast this response with the Serum Institute’s decision to suspend trials in India after AstraZeneca halted its clinical trials in September due to “unexplained illness” in a study participant.
The new controversy came at a time when questions about the vaccine had already been raised after AstraZeneca and the University of Oxford acknowledged a manufacturing error. Depending on the strength at which the doses were administered, the vaccine appeared to be either 90% or 62% effective. Average efficacy, the developers said, was 70% in phase three trials. But questions arose as to why there was such a large variation in the effectiveness of the vaccine at different doses and why a smaller dose seemed to produce much better results.
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