The Serum Institute of India (SII) on November 29 rejected the claims that a COVID-19 vaccine candidate to be manufactured by it had adverse effects on a participant during the Phase 3 trial, and threatened to seek damages in “excess of Rs 100 crore” for “malicious” allegations.
The 40-year-old Covishield vaccine trial participant has sought Rs 5 crore as compensation from SII, citing side effects of virtual neurological breakdown and impairment of cognitive functions after taking the dose of the Covid shot.
“Our client developed severe neurological health complications after he was given the test dose. We had sent a legal notice to the Serum Institute; Indian Council for Medical Research (ICMR); AstraZeneca, UK; Drugs Controller General of India; Andrew Pollard, Chief Investigator, Oxford Vaccine Trial; The Jenner Institute Laboratories, University of Oxford; and the Vice-Chancellor of Sri Ramachandra Higher Education and Research,” N.G.R. Prasad, Advocate, Row & Reddy, said.
‘Covishield’, the coronavirus vaccine, is being developed by the University of Oxford and AstraZeneca in collaboration with the Pune-based Serum Institute of India (SII).
The Pune-based pharmaceutical company issued a statement saying that while it sympathized with the volunteer’s medical condition there was “absolutely no correlation with the vaccine trial and the medical condition of the volunteer”.
“The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic to the volunteer’s medical condition, there is absolutely no correlation between 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,” Serum Institute of India said in a statement.
The volunteer is falsely laying the blame for his medical problems on the COVID-19 vaccine trial, the statement added.
The SII said 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,” the SII alleged.
A criminal case has also been filed against the volunteer and he is likely to receive the notice by Monday.
