Men ride motorcycles alongside a supply truck of the Serum Institute of India, the world’s largest vaccine manufacturer, in Pune, India, on May 18, 2020. Photo: Reuters / Euan Rocha
New Delhi: A 40-year-old Chennai-based participant in the ‘Covishield’ vaccine trial developed by the Pune-based Serum Institute of India (SII) has sent a legal notice to the company seeking Rs 5 crore as compensation.
A legal notice sent to the vaccine developer on behalf of the participant alleged that the man suffered severe neurological impairment after the trial vaccine was administered, according to a report in the Economic times.
The legal notice, which was also sent to the drug regulatory authority, alleged that no public disclosure was made even after the participant reported his condition and contrasted this response with the decision to suspend trials in India after the giant AstraZeneca pharmacist stopped its clinical trials due to “unexplained illness” in a study participant.
Trials of the Oxford-AstraZeneca vaccine were resumed after approval by regulatory authorities.
The participant has also demanded, through the legal notice, that the vaccine trial be stopped immediately, he reported. The Hindu.
The defender of the complainant told the Economic times They are awaiting a response on the legal notice, which was sent on November 21 and was intended to file a petition for appeal in court next week.
Copies of the legal notice were also sent to the CEO of AstraZeneca, UK, chief investigator of the Oxford trials, and vice chancellor of the Sri Ramachandra Institute in Chennai, where the experimental injections in the phase 3 vaccine trials were administered to the participant.
Sri Ramachandra Institute principal investigator SR Ramakrishnan said a “thorough investigation” had been carried out and the report of the investigation was presented to the Safety and Data Monitoring Board, SII and the drug regulator within of the stipulated time. “He recovered very well and we treated him according to protocol and even came back for a follow-up. All expenses were borne by the hospital, “said Ramakrishnan, who had treated the patient, adding that” the matter was now fine. “
“We do not believe the adverse event is related to the vaccine,” Ramakrishnan said, adding that in the absence of direction from the sponsor or drug regulator, the trials were not suspended.
The legal notice stated that the Chennai man was “assured” that the vaccine was “safe.” “Therefore, the client was led to believe that taking the Covishield trial vaccine was safe and that the associated risks … would hardly lead to serious side effects, let alone serious adverse effects,” the advisory said. The man’s wife said The Hindu that her husband had joined the trial in the “spirit of public service.”
The participant’s attorney, Rajaram, said the fact sheet had warned of “injection site reaction, pain, tenderness, fever, chills, fatigue, headache or joint pain, among other common symptoms.” However, after receiving the vaccine on October 1, his client began to experience severe headaches and was unable to answer questions. The participant also suffered from “acute neuroencephalopathy,” the notice said.
The notice also said that the participant “should be compensated, at a minimum, for all the suffering that he and his family have suffered and are likely to suffer in the future.”
Although the participant was discharged from the hospital on October 26, he is still “not stable” and continues to experience “severe mood swings, comprehension problems and … (finds it) difficult to do even simple and routine things “, says the complaint. and added that there was no follow-up by the hospital, the drug regulatory authority, the company or sponsors asking about the participant’s health.
The man’s discharge summary indicates that he was “discharged upon request” and was recovering from “acute encephalopathy.” He was also deficient in vitamin B12 and vitamin D, and had a probable “connective tissue disorder.”
The participant’s wife said that her husband had not fully recovered. “We are seeing another neurologist at Apollo Hospital and his tests confirm a dysfunction in his brain. He is slowly recovering and is better than he was [in October] but he can no longer work as before and is passionate about his work, “he told the national newspaper.
