A Chennai man who volunteerd for the Covishield vaccine being developed by the Pune-based Serum Institute of India (SII) has sought Rs 5 crore compensation for the neurological complications he developed after being administered the test dose.
The 40-year-old Chennai-based business consultant was a volunteer for the third phase of the vaccine trial conducted by SII. He was administered the shot at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.
He has now sought Rs 5 crore compensation for allegedly suffering serious neurological and psychological symptoms after taking the dose.
A law firm on his behalf has now sent a legal notice to Director General, ICMR, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator, 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.
"Our client developed severe neurological health complications after he was given the test dose. We had sent a legal notice to the Serum Institute; Indian Council for Medical Research (ICMR); AstraZeneca, UK; Drugs Controller General of India; Andrew Pollard, Chief Investigator, Oxford Vaccine Trial; The Jenner Institute Laboratories, University of Oxford; and the Vice Chancellor of Sri Ramachandra Higher Education and Research," NGR Prasad, Advocate, Row & Reddy, told IANS.
"The notice was issued on November 21 and till now we have not received any reply from any of the parties to whom the notice was sent," Prasad added.
As per the notice, the 40-year old male volunteer is married and has two kids aged about 12 and 7 years.
The notice the law firm 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 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.
The notice also said that testing, manufacturing and the distribution of the vaccine should also be stopped immediately, "failing which he has no other option except to take appropriate legal action against all the concerned parties, who would be made responsible for all the costs and consequences".
DCGI, institutional ethics committee investigating claim
The Drugs Controller General of India and the institutional ethics committee at the implementation site are investigating the claim, officials said.
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," Dr Panda said.
The SII has partnered with British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, registered as Covishield in India.
The DCGI had on September 11 directed Serum 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 of India to recommence the trial.