Vaccine trial participant alleges serious side effects, seeks Rs 5 crore in damage
Chennai/New Delhi: A 40-year-old man who took part in the 'Covidshield' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought Rs five crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial.
Drugs Controller General of India and the institutional ethics committee at the implementation site are investigating the allegation.
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, 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.
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.
Meanwhile, rejecting all the claims, vaccine major SII threatened to seek heavy damages for "malicious" allegations.
"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," Serum Institute of India said in a statement.
The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial, it added.
"It is evident 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 100 crore for the same and will defend such malicious claims," Serum Institute said.
