Vaccine: DCGI, ethics committee probing claim of ill-effect in trial
The Drugs Controller General of India and the institutional ethics committee at the implementation site are inspecting if the negative event as claimed to have been suffered by a Covid-19 vaccine volunteer in Chennai are linked with the shot administered to him.
A 40-year-old business consultant from Chennai, who received a trial shot of the vaccine administered to him by the Pune-based Serum Institute of India, has sought for Rs 5 crore as compensation for allegedly developing serious psychological and neurological symptoms after taking the dose.
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.
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, AstraZeneca UK, Professor Andrew Pollard, Chief Investigator, Oxford Vaccine Trial and Vice Chancellor of Sri Ramachandra Higher Education and Research.
Besides the compensation of Rs 5 crore, the man has also demanded that the testing, manufacturing and distribution of the vaccine be stopped immediately.
Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, said, “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.”
The DCGI had on September 11 directed the SII not to sign up any new volunteers in phase II and III trials of the Oxford Covid-19 vaccine candidate till further orders. This comes in view of the pharma giant stopping the vaccine trials abroad due to an ''an unexplained illness'' of a volunteer.
However, on September 15 it permitted the Serum Institute of India to recommence the trial.
"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,” the November 21 notice of the law firm states.
"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 adds.
The notice also states that the 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".