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Coronavirus | ‘Covishield’ vaccine volunteer sues Serum Institute of India, Oxford Group over ‘adverse reaction’

A 40-year-old volunteer for ‘Covishield’, the candidate vaccine being tested by the Pune-based Serum Institute of India (SII), has sued the company for ₹5 crore, alleging that the vaccine triggered an adverse reaction, which includes neurological impairment and an inability to get back to the life before being inoculated.

He has also demanded, via a legal notice sent to the SII, AstraZeneca and the Oxford Vaccine Group, that the vaccine trial, which is now being tested on 1,600 volunteers in India, be immediately halted.

The person’s discharge summary says 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”.

Dr. S.R. Ramakrishnan, who was the lead investigator for the Chennai arm of the trial and had treated the patient, told The Hindu that the “subject was now alright” but directed further questions to the Serum Institute spokesperson. “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,” he said.

Also read: COVISHIELD completes enrolment of Phase-3 clinical trials under partnership of ICMR and Serum Institute of India

The hospital’s institutional ethics committee had given a letter, Dr. Ramakrishnan said, that said the adverse reaction was not due to the study vaccine, and this was also communicated to the Drug Controller General of India (DGCI), the apex regulator.

He said that the recruitment of volunteers for the trial had already concluded but his hospital had not since received any communication from the DCGI.

When contacted, an SII spokesperson did not offer additional comment.

The Hindu reached out to the person’s wife, who said her husband had signed up for the trial in the “spirit of public service”. The person was enrolled for the third phase of the human trial at the Sri Ramachandra Institute of Higher Education and Research, Chennai. She said that the multiple “categorical assertions”— made in the participant information sheet — that the vaccine was safe and did not cause serious reactions had “convinced him” that it was “safe”.

Also read: Vaccine shot ‘painless’, say Covishield trial volunteers

To be sure, clinical trials are conducted, usually via a three-stage process, to verify if they indeed are safe, result in the desired immune reaction, and are efficacious.

The volunteer, who signed the ‘Informed Consent Form’ on September 29, 2020, was administered a test for antibodies against COVID-19 to rule out prior infection, and received a vaccine shot on October 1. The Covishield vaccine is a double dose vaccine trial, with some volunteers getting an actual vaccine and some a placebo, 28 days apart.

A test 11 days later revealed the presence of antibodies, “proof” that the person had indeed received the vaccine and not a placebo. Ten days after the shot, he complained of a severe headache, followed by vomiting that confined him to the bed for the rest of the day. His wife, according to the legal notice, said there was a total “behavioural change” in her husband and he seemed unaware of his surroundings. “He showed irritation towards light and sound, and was resisting any effort to make him get up from bed,” the notice states.

He was taken in an ambulance to the emergency ward of the Sri Ramachandra Medical College and Hospital. The hospital’s discharge summary, which The Hindu has viewed, notes that he was “in an altered mental state” and was “disoriented”. During his hospitalisation from the October 11 to October 26, when he was discharged, he underwent a CT scan as well as an MRI, a COVID-19 test, and even his cerebrospinal fluid was examined. He was also shifted to the Intensive Care Unit.

The patient’s wife told The Hindu that her husband has 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 said.

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Printable version | Jan 16, 2021 9:04:14 AM | https://www.thehindu.com/sci-tech/health/coronavirus-covishield-vaccine-volunteer-sues-serum-institute-of-india-oxford-group-over-adverse-reaction/article33201686.ece

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