After a ‘Covishield’ vaccine volunteer sued the Pune-based Serum Institute of India (SII) and the Oxford Group over ‘adverse reaction’ during the vaccine trial , the SII on Sunday denied the allegations and dubbed them “malicious” and “misconceived”.
Coronavirus | DCGI and institutional ethics committee investigating claim of adverse event in COVID-19 vaccine trial: officials
The SII said it would seek damages in excess of ₹100 crore and would defend such malicious claims.
“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. The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial,” the SII said in a statement.
It said that the volunteer’s claim was “malicious” as he had been specifically informed by the medical team that the complications that he suffered were independent of the vaccine trial he participated in. “In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company. It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive,” the statement added.
Also read: 'No side effects seen in vaccine trial volunteers'
The 40-year-old man, who had taken part in the vaccine trial, said he suffered serious side effects, including a virtual neurological breakdown and impairment of cognitive functions.
He sought compensation to the tune of ₹5 crore in a legal notice to the SII, AstraZeneca and the Oxford Vaccine Group, besides seeking a halt to the trial.
Alleging that the candidate vaccine was not safe, he has also sought cancelling approval for the testing, manufacture and distribution of the vaccine.
‘DCGI is probing case’
The Drugs Controller General of India and the institutional ethics committee at the implementation site are investigating if the alleged adverse event is related to the shot administered to him.
Samiran Panda, who heads the Epidemiology and Communicable Diseases division of the Indian Council of Medical Research, 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.
Legal notice
The notice given on November 21 by a law firm on behalf of the volunteer 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 ₹5 crores within two weeks from the receipt of this notice,” it said.
(With PTI inputs)
