An Oxford COVID-19 vaccine trial participant in Chennai has sought a compensation of Rs. 5 crore for allegedly suffering serious side effects from the shot, a claim which is being investigated by the Drugs Controller General of India and the institutional ethics committee at the trial site.

A senior ICMR official said that a preliminary assessment has not indicated any causal link between the alleged adverse events shown by the volunteer and the 'Covishield' vaccine. The 40-year-old business consultant, who was a volunteer for the third phase of the vaccine trial conducted by Serum Institute of India (SII), has alleged he suffered a virtual neurological breakdown and impairment of cognitive functions, and has sent a legal notice to SII and others. However, the SII on November 29 rejected the charges as "malicious and misconceived" and said it will seek damages in excess of Rs 100 crore.

The man was administered the shot at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1. A law firm on his behalf has now sent a legal notice to Director General of ICMR, CEO, Serum Institute of India Private Limited, Pune, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator of Oxford Vaccine Trial and Vice Chancellor of Sri Ramachandra Higher Education and Research.

The man has sought a compensation of Rs 5 crore and that the testing, manufacturing and distribution of the vaccine be stopped immediately. The SII has partnered with British-Swedish biopharmaceutical giant AstraZeneca AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.

Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, said 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.

"Any hurried inquiry or inference is prone to be wrong. Both the institutional ethics committee and the DCGI are investigating the causal links, if any, between the adverse events and investigational product, which is an anti-coronavirus vaccine. A preliminary assessment has not indicated any causal link as yet," Dr Panda said.

According to the legal notice, the information provided in the 'Participant Information Sheet (PIS)' was absolutely certain that Covishield, the vaccine developed by Oxford University, is safe and the man was hence led to believe it. Hence, he decided to become a volunteer and signed the informed consent on September 29 and the test result for antibodies against coronavirus turned negative the same day. On October 1, he was administered the vaccine.

Though there was no side effects for the first 10 days, he subsequently had episodes like severe headache and vomiting. Detailing the sequence of events since October 11 when he was admitted to the Ramachandra Hospital and as narrated by the man's wife, the notice said he showed behavioural changes.

He could neither recognise anyone nor speak and was totally disoriented and was shifted to the ICU and was on October 26 "discharged at our (family's) request", it said. At home, he seemed quite disoriented at times and was unable to relate to things or work. He would not have volunteered for the test vaccine if all the potential risk factors of the test vaccine had been known to him, the notice given on November 21 said. "Our client states that he must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in the future."

"He further states that he is still far from being all right and has to be under medical care for a long time to come. Therefore, for all the trauma he is undergoing and with an uncertain future in his health, he should be given a financial compensation of Rs. 5 crores within two weeks from the receipt of this notice," it said.

Serum Institute of India said in a statement that the allegations in the notice are "malicious and misconceived" and the volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial. "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," it said.

"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," Serum Institute said.

It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive, it added. "The Serum Institute of India will seek damages in excess of (Rs) 100 crore for the same and will defend such malicious claims," the statement said.

The DCGI had on September 11 directed Serum Institute of India (SII) to suspend any new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study. However, on September 15 it permitted the Serum Institute to recommence the trial.