SII to sue vaccine trial participant for Rs. 100 crore
The Serum Institute of India (SII) has said that it will seek Rs. 100 crore in damages from a COVID-19 vaccine trial participant for complaining about side-effects. The participant, a 40-year-old business consultant, had recently sent a legal notice to SII and others, alleging serious side-effects. The institute is conducting trials for Oxford University and AstraZeneca's vaccine, dubbed Covishield in India.
40-year-old had participated in Phase III trials
The 40-year-old had participated in the third phase of the vaccine trials conducted at the Sri Ramachandra Institute of Higher Education and Research (SRIHER) site in Chennai. He claimed that the side-effects he faced included a virtual neurological breakdown and impairment of cognitive functions. He sought financial compensation of Rs. 5 crore and demanded that the vaccine's testing, manufacturing, and distribution be halted immediately.
Apart from SII, AstraZeneca, Oxford, Indian authorities also received notices
He had also sent the legal notice to the Indian Council of Medical Research's Director-General, Drugs Controller General of India, Central Drugs Standard Control Organization, AstraZeneca UK CEO, SII CEO, Oxford vaccine trial chief investigator Professor Andrew Pollard, and Sri Ramachandra Higher Education and Research Vice-Chancellor.
Participant claimed he is 'undergoing trauma'
The notice demanded that the vaccine development be halted, threatening "appropriate legal action against all concerned parties" upon failure to do so. He sought financial compensation of Rs. 5 crore in light of "all the sufferings that he and his family have undergone and are likely to undergo in future." He claimed he is undergoing "trauma" and mentioned an "uncertain future in health."
Allegations 'malicious and misconceived,' says SII
In a statement on Sunday, the SII described the allegations made by the trial participant as "malicious and misconceived." The SII said there was "no correlation between the vaccine trial and the medical condition of the volunteer." The institute further said that there seems to be a financial motive behind the "malicious" allegations, adding that it will seek damages of Rs. 100 crore.
'Volunteer falsely laying blame for his medical problems on vaccine'
SII said, "The volunteer is falsely laying the blame for his medical problems on the vaccine trial." It added, "...The volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company."
DCGI, institutional ethics committee conducting investigation
The DCGI and the institutional ethics committee at the implementation site are investigating if the adverse event as claimed to have been suffered by a trial participant in Chennai is related to the shot administered to the 40-year-old man.
