The Serum Institute of India (SII), which has been conducting trials for its Covishield vaccine, said that it would seek damages of Rs 100 crore from one of its trial candidates. The candidate had alleged side-effects from the vaccine dose.
"The Serum Institute of India will seek damages in excess of (Rs) 100 crore for the same and will defend such malicious claims," the Pune-based drugmaker said.
The lawyers of the candidate, who was a volunteer for the third phase of Covishield, sent a legal notice to the SII and others, alleging that he suffered a virtual neurological breakdown and impairment of cognitive functions, and sought a compensation amount of Rs 5 crores.
Saying that it was sympathetic with the candidate's medical condition, the SII in its statement added, "The claim is malicious because 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," it further said.
The SII asserted that it would take all steps to defend itself from all such malicious claims.
According to the reports, the candidate was administered the shot of Covishield at the Sri Ramachandra Higher Education and Research (SRIHER) in Chennai on October 1.
The notice from the candidate's lawyers went on to say that after ten days of no side-effects, he later started experiencing severe headaches, total behavioural change, and irritation towards light and sound. It also said that he could not recognise or speak to anyone.
He was discharged from hospital after suffering from "Acute Encephalopathy", it said.
The notice given on November 21 stated that it was "an extreme side effect of the test vaccine..."
"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 Rs. 5 crores within two weeks from the receipt of this notice," the notice said.
It was issued based on his wife's testimony and sent on his behalf to the Director-General of the Indian Council of Medical Research (ICMR); CEO, Serum Institute of India Private Limited, Pune; Drugs Controller General of India (DCGI); Central Drugs Standard Control Organisation; CEO, Astra Zeneca UK; Professor Andrew Pollard, Chief Investigator of Oxford Vaccine Trial, and the Vice-Chancellor of SRIHER.
The SRIHER has not made any comment on the matter yet.
Other reports suggested that the institutional ethics committee and the DCGI were investigating if there were any causal links.
The SII has partnered with the global biopharmaceutical giant AstraZeneca and the Oxford University for manufacturing their vaccine candidate for COVID-19 in India. Its CEO Adar Poonawalla recently told media that it would approach the Indian regulators for emergency authorisation to use the vaccine within two weeks.
