A 40-year-old Chennai-based participant in the trial for the Covishield vaccine developed by the Pune-based Serum Institute of India has sued the company, claiming he has suffered serious neurological impairment after the under-trial coronavirus vaccine was administered to him, PTI reported on Sunday.

Serum Institute of India has partnered with the British drugmaker AstraZeneca and the University of Oxford to conduct trials on its vaccine in India and produce it if it secures approval.

The man has sought Rs 5 crore as compensation. The participant has also demanded that the vaccine trial be immediately halted and all plans for its “manufacture and distribution” be suspended, failing which legal action would be taken.

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. They also intend to file a writ petition in the court next week.

Copies of the legal notice have been sent to the Chief Executive of AstraZeneca in the United Kingdom, 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 on October 1.

On Sunday evening, the Indian Council of Medical Research said that the Drugs Controller General of India and the institutional ethics committee at the implementation site are investigating the matter.

Samiran Panda, who heads the Epidemiology and Communicable Diseases division of the ICMR, told PTI that the causal link, if any, of the serious adverse events with the investigational product is objectively assessed in any clinical trial following “a pre-defined scientific pathway and within a stipulated period”.

SR Ramakrishnan, the lead investigator at Sri Ramachandra Institute, meanwhile, said that an “extensive investigation” had been carried out and the report for the same was submitted to the Data and Safety Monitoring Board of the Serum Institute 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 told The Economic Times, adding that “subject was now alright”.

He said that the institute did not think that the “adverse event” was related to the vaccine.

The investigator added that in the absence of any direction from the sponsor or the drug regulator, trials for Covishield were not suspended.

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

A spokesperson for the Serum Institute of India said in a statement on Sunday that the allegations in the notice “are malicious and misconceived”.

“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 statement said. “The volunteer is falsely laying the blame for his medial problems on the Covid vaccine trial.”

It added: “The claim is 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.”

The spokesperson alleged that the “intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India, will seek damages in excess of Rs 100 crore for the same and will defend such malicious claims.”

What are the allegations?

The legal notice claimed that before signing up for the trial, the man was “assured” that the vaccine was found to be safe, according to The Economic Times. “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”. 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”.

The participant’s counsel, R Rajaram, said that the Participant Information Sheet had warned of “injection site reaction, pain, tenderness, fever, chills, fatigue, headache or joint pain, among other common symptoms”.

Besides, the advocate said the information sheet even claimed that there was “a rare possibility of severe Covid infection” if his client contracted the disease post-vaccination.

However, after receiving the vaccine on October 1, his client started to experience severe headaches and was not able to respond to questions, he told The Economic Times. The participant also suffered “acute neuro encephalopathy,” the notice stated.

The complaint added that the man also showed behavioural changes, according to PTI. “He could neither recognise anyone nor speak and was totally disoriented and was shifted to the ICU [intensive care unit] and was on October 26, “discharged at our [family’s] request,” it said.

But he “is still not stable, has severe mood swings, problems with comprehension and [finds it] difficult to do even simple, routine things,” the complaint claimed.

“The trauma he underwent after taking it clearly proves that the vaccine was not safe as made out to be and all the stakeholders were trying to hide the adverse effect that the vaccine has had on him. He has gone through extreme sufferings, both biologically and psychologically. The vaccine had led to a virtual neurological breakdown in him.” 

— Legal notice, PTI

The legal notice stated that no public disclosure about the incident was made even after the participant reported his condition. It contrasted this response with the Serum Institute’s decision to suspend trials in India after pharma giant AstraZeneca paused its clinical trials in September because of “an unexplained illness” in a participant in the study.

It said that it was impossible to “quantify monetarily, the sufferings, trauma, pain and humiliation (of hands, legs and body being tied and fastened firmly to the bed), which he and his family have undergone and are likely to undergo for a long time to come”.