A Chennai-based business consultant has alleged that the COVID-19 vaccine candidate being developed by AstraZeneca and Oxford has caused serious neurological and psychological symptoms after he took a dose during trials.
The 40-year-old man, who volunteered for the third phase of the vaccine trial, being conducted by Serum Institute of India, has asked for compensation of ₹5 crore along with immediate suspension of testing, manufacturing, and distribution of the vaccine, Covishield.
A legal notice was sent by a law firm representing the person on November 21 to the Director General, ICMR, Drugs Controller General of India; Central Drugs Standard Control Organisation; CEO, AstraZeneca UK; Professor Andrew Pollard, Chief Investigator, Oxford Vaccine Trial; Serum Institute, Pune; and Vice-Chancellor of Sri Ramachandra Higher Education and Research.
The legal notice reads: “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 ₹5 crore within two weeks from the receipt of this notice.”
The notice states that if the testing, manufacturing, and distribution are not stopped immediately, then the complainant will have “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”.
The Drugs Controller General of India (DCGI) and the institutional ethics committee at the implementation site are looking into whether the man’s symptoms were caused by the shot administered to him.
The man was administered the shot on October 1 at Sri Ramachandra Institute of Higher Education and Research (SRIHER) in Chennai.
Responding to the legal notice, Serum Institute said the allegations are “malicious” and “misconceived”. There is no correlation with the trial and the volunteer’s medical condition, it said. “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,” it said.
Dr Samiran Panda, head of the epidemiology and communicable diseases (ECD) division of ICMR, told PTI: “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.”
In early September, the DGCI directed Serum Institute of India (SII) to suspend taking new volunteers in phase 2 and 3 clinical trials of the Oxford vaccine candidate till further instructions, allegedly following ‘’an unexplained illness’’ in a volunteer, due to which AstraZeneca had paused clinical trials in other countries. A few days later, AstraZeneca allowed SII to resume the trial.
AstraZeneca recently also came in for criticism for a dosage error. However, SII has said it will seek emergency use authorisation for the AstraZeneca-Oxford COVID-19 vaccine within about two weeks.
(with inputs from PTI)