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 Phase 3 trial, and threatened to seek damages in "excess of Rs 100 crore" for "malicious" allegations.
The 40-year-old man who took part in the 'Covidshield' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to SII and others, besides seeking a halt to the trial.
The participant was administered the vaccine at the Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.
“The allegations in the notice are malicious and misconceived. While the SII 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 SII said in a statement.
The volunteer is falsely laying the blame for his medial problems on the COVID-29 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.
The Pune-based vaccine manufacturer said the intention behind the spreading of such malicious information is an oblique pecuniary motive, and the company will seek damages in excess of 100 crore for the same and will defend such malicious claims.
The vaccine maker has collaborated with Oxford University and AstraZeneca for making Covidshield, and is conducting trials in India.