The Covid vaccine, Covishield, will be produced in India by the Serum Institute (Representational)
The Serum Institute of India has responded to the “malicious and misleading” allegations by preparing a Rs 100 million defamation lawsuit against a Covishield coronavirus vaccine trial participant who claimed to suffer a “virtual neurological collapse” after receiving a dose.
In a statement to NDTV late Sunday, the Serum Institute said that while it was sympathetic to the volunteer’s medical condition, “there was absolutely no correlation with the vaccine trial and the volunteer’s medical condition.”
“The allegations in the ad are malicious and misconstrued. While the Serum Institute of India is sympathetic to the medical condition of the volunteer, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer falsely blames their medical problems in the COVID vaccine trial, “the statement said.
“The claim is malicious because the medical team specifically informed the volunteer that the complications he was suffering were independent of the vaccine trial he underwent. Despite being specifically informed of the same, he chose to go public and defame the reputation. of the company, “the statement added.
The Serum Institute said it would seek damages in excess of Rs 100 million and would continue to defend itself against all such malicious claims.
Earlier, a 40-year-old Chennai man, who volunteered for the third phase of the Covid vaccine trial conducted by the Serum Institute, claimed Rs 5 crore as compensation for “a serious adverse event after the vaccine was administered in test”. .
The dose was administered at the Sri Ramachandra Institute of Higher Education and Research in Chennai (SRIHER) on October 1.
According to his legal notice, which was filed on November 21, ten days later he began to experience “severe headaches”, “total change in behavior” and “irritation towards light and sound.” Later, the ad claims, he was unable to recognize or speak to anyone.
On October 26 he was released from the hospital after suffering from “acute encephalopathy” which, according to the advisory, was “an extreme side effect of the test vaccine …”
The notice also cites what it says is an excerpt from the trial’s “Participant Information Sheet (PIS)”, which reads: “This vaccine has been previously tested in about 500 healthy adults (and) ages 18 to 55 in (the) United Kingdom (United Kingdom) and was deemed safe. “
This, the advisory says, “led (the man) to believe that taking the Covishield test vaccine was safe and that the risks associated with taking such a vaccine would hardly lead to serious side effects.”
The Sri Ramachandra Institute, which has also been named in the notice, said “no comment” was its formal response at this stage.
However, sources from the institute said that he had a role in the Phase 2 and Phase 3 trials and that all information about the patient’s condition had been shared with other trial sponsors in accordance with the protocol.
The Comptroller General of Drugs of India (DCGI) and an ethics committee from the Sri Ramachandra Institute will investigate the man’s claim, according to a report by the PTI news agency.
The Covishield vaccine is among the most promising candidates in the later stages of testing around the world. On Saturday night, SII CEO Adar Poonawalla, after meeting with Prime Minister Narendra Modi, said the company would apply for an emergency use license for Covishield.
Earlier this week, Mr. Poonawalla told NDTV that a minimum of 100 million doses would be available by January and hundreds of millions by the end of February.
With input from PTI
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