The Serum Institute of India on Tuesday, 1 December, repeated their assertion that their COVID-19 vaccine candidate Covishield is “safe and immunogenic”. The incident with the Chennai volunteer was in no way induced by the vaccine, SII said, adding that all regulatory and ethical processes and guidelines were followed, reported ANI.
The incident pertains to a 40-year-old Tamil Nadu-based Covidshield trial volunteer who has claimed that he suffered adverse reactions as a result of the trial.
SII had earlier also responded to the allegations by the participant by preparing a Rs 100 crore defamation suit against him for claiming that he suffered a "virtual neurological breakdown" after being administered a dose, NDTV reported.
The vaccine maker on Tuesday reportedly said that the Principal Investigator, Data and Safety Monitoring Board (DSMB) and Ethics Committee had also stated that it was non-related issue.
Volunteer’s Claims Malicious, Misconceived: SII
“The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned,” SII further said on Tuesday.
Referring to the 40-year-old Tamil Nadu-based Covidshield trial volunteer’s claims as “malicious and misconceived”, Serum Institute of India (SII), on Sunday had stated:
"“While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medial problems on the COVID vaccine trial.”"
The company also informed that they will seek damages in excess of 100 crores for the same from the volunteer and will defend “such malicious claims”.
The volunteer had sent a legal notice to the Pune-based company for suffering adverse effects as a result of their vaccine and demanded Rs 5 crore in compensation., Economic Times reported.
Further Serum Institute explained, why, according to them, the claim was “malicious”.
"“…because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In-spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company. “ "
Further, SII alleged that the volunteer had claimed adverse reaction and blamed the vaccine trial for it evidently because of an “oblique pecuniary motive”.
The volunteer was a part of phase three trials that were being conducted at Shri Ramachandra Institute of Higher Education and Research, Chennai.
Developed by AstraZeneca internationally, the vaccine is being manufactured by India’s largest vaccine manufacturer in the country.
The notice states that the participants suffered serious side-effects after being vaccinated, and no public disclosure was made for this. The participant has demanded Rs 5 crore in compensation.
This comes at a time when the Serum Institute immediately halted its trials once an adverse effect was reported in the UK, and a regulatory clearance was sought before continuing the work.
The legal notice sent on 21 November by advocate R Rajaram is still awaiting a response from the vaccine manufacturer, and a writ petition is likely in court next week.
“We will file a writ petition next week,” R Rajaram told Economic Times.
The Principal Investigator at Shri Ramachandra Institute, SR Ramakrishnan has said “An extensive investigation was carried out and we don’t think the adverse effect was related to the vaccine. The report was submitted to the Data and Safety monitoring board, SII and the drug regulator within the stipulated time.”
However, the notice has mentioned that the participant received the vaccine on 1 October 2020 and on 11 October started experiencing “severe headaches and was not able to respond to questions.” It alleges that he suffered “acute neuro encephalopathy” and while he was discharged from the hospital on 26 October is “still not stable, has severe mood swings, problems with comprehension and still finds it difficult to do doing simple, routine things.”
It continued, “The client was led to believe that taking the Covidshield test was safe and risks associated would hardly lead to any side effects, let alone severe adverse effects.”
Rajaram maintains that what the participant experienced was not connected to the vaccine trial, and there has not yet been any follow-up from the hospital, the company, drug regulatory authority or the sponsors.
(With inputs from Economic Times and ANI)
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