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Vaccine Trial Participant Sues Serum Institute for ‘Severe Adverse Effect’ – The Wire Science



Men ride on a motorbike past a supply truck of India’s Serum Institute, the world’s largest maker of vaccines, in Pune, India, May 18, 2020. Photo: Reuters/Euan Rocha

New Delhi: A 40-year-old Chennai-based participant in the trial for the ‘Covishield’ vaccine developed by the Pune-based Serum Institute of India (SII) has sued the company for Rs 5 crore.

A legal notice sent to the vaccine developer on behalf of the participant alleged that the man suffered serious neurological impairment after the under-trial vaccine was administered to him, 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 pharma giant AstraZeneca paused its clinical trials because of “an unexplained illness” in a participant in the study.

Trials for the Oxford-AstraZeneca vaccine resumed after approval from regulatory authorities.

The participant has also demanded, via the legal notice, that the vaccine trial be immediately halted, reported The Hindu.

The advocate for the complainant told the Economic Times that they are waiting for a response on the legal notice, which was sent on November 21 and intended to file a writ petition in court next week.

Copies of the legal notice have also been sent to the chief executive of AstraZeneca, UK, chief investigator of the Oxford trials and vice-chancellor of Sri Ramachandra Institute in Chennai, where the participant was administered the experimental shots under the phase 3 trials of the vaccine.

The lead investigator at Sri Ramachandra Institute, S.R. Ramakrishnan, said that an “extensive investigation ” had been carried out and the report for the same was submitted to the Data and Safety Monitoring Board, SII and the drug regulator within the stipulated time. “He recovered very well and we treated him as per protocol and he even came back for a follow-up. All the expenses were borne by the hospital,” Ramakrishnan, who had treated the patient, said and added that “subject was now alright”.

“We don’t think the adverse event was related to the vaccine,” Ramakrishnan said and added that, in the absence of any direction from the sponsor or the drug regulator, trials were not suspended.

The legal notice claimed that the Chennai-based man was “assured” that the vaccine was found to be “safe”. “The client was therefore led to believe that taking the Covishield test vaccine was safe and risks associated… would hardly lead to any serious side effect, leave alone severe adverse effect,” the notice said. The man’s wife told The Hindu that her husband had signed up for the trial in the “spirit of public service”.

The participant’s counsel, Rajaram, said that the information 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 started to experience severe headaches and was not able to respond to questions. The participant also suffered “acute neuro encephalopathy,” the notice stated.

The notice also stated that the participant “must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in future”.

Even though the participant was discharged from hospital on October 26, he is still “not stable” and continues to experience “severe mood swings, problems with comprehension and… (finds it) difficult to do even simple, routine things,” the complaint said and added that there had been no follow up from the hospital, the drug regulatory authority, the company or sponsors inquiring about the participant’s health.

The man’s discharge summary states he was “discharged at request” and was recovering from “acute encephalopathy”. He also had Vitamin B12 and Vitamin D deficiency, and had a probable “connective tissue disorder”.

The participant’s wife said that her husband had not entirely recovered. “We are consulting another neurologist at the Apollo Hospital and his tests confirm dysfunction in his brain. He is recovering slowly and is better than what he was [in October] but he is unable to work as before and he is passionate about his work,” she told the national daily.



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