Amid controversy surrounding a 40-year-old Chennai subject in the Oxford-AstraZeneca vaccine clinical trial falling seriously ill and demanding Rs 5 crore in damages from the Pune-based Serum Institute of India (SII) , Mardi’s company assured that its Covishield vaccine candidate would not be marketed for mass use unless it is proven “immunogenic and safe”.
Responding to concerns about the serious adverse event reported by a volunteer in Chennai, SII said, “The incident with the volunteer from Chennai, while very unfortunate, was in no way caused by the vaccine, and SII is sympathetic to the state of health of the volunteer. ”
Meanwhile, the SII spokesperson said, “However, we would like to make it clear that all required regulatory and ethical processes and guidelines were followed diligently and rigorously. Relevant authorities were notified and the lead investigator, the Drug Safety Monitoring Board, and the ethics committee independently cleared it as a non-vaccine trial issue, after which we submitted all reports and data related to the medication incident. Comptroller General of India (DCGI). “
SII further clarified that it was only after “finishing” all the required processes that it continued with the trial. “We would like to assure everyone that the vaccine will not be marketed for mass use unless it is proven to be immunogenic and safe. Given the complexities and abuse of language that exist regarding vaccination and immunization, the legal opinion has been sent to protect the reputation of the company, which is being unfairly slandered, ”the company added.
The DCGI is now conducting an in-depth investigation into the documents filed by the SII.
The volunteer, who suffered from a neurological illness and was hospitalized for more than a week, had sent the company a legal opinion asking for Rs 5 crore. His lawyers said the participant had not received any formal communication. from the company saying his illness (acute encephalopathy) was unrelated to the vaccine.
Separately, the law firm Advocates Row & Reddy and R Rajaram, which sent a formal notice on behalf of the 40-year-old, claimed that the trial sponsor (or SII) did not covered the medical expenses he had incurred. In response, SII said the allegations were “malicious and false” and that it would seek Rs 100 crore in damages.
Dr Shahid Jameel, senior virologist and director of Ashoka University, told Business Standard he found the answer “disappointing.”
Patient advocacy groups raised concerns, alleging that volunteers who received the injections after the adverse event had not been made aware of the event and what happened to any of the participants.