Pune: Alleging serious neurological side effects after taking the experimental dose of COVISHIELD, the vaccine candidate being produced by Pune-based Serum Institute of India (SII), a 40-year-old man from Chennai who volunteered for the human trials has sought Rs 5 crore compensation from the vaccine manufacturer. In response, the SII has slapped a Rs 100 crore defamation suit against the Chennai man.
The DCGI and the institutional ethics committee at the implementation site at Sri Ramachandra Medical University in Porur are investigating if the adverse event as claimed by the Chennai participant are related to the shot administered to him.
The Chennai-based volunteer has sent a notice through a law firm to SII along with Director General, Indian Council of Medical Research, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, AstraZeneca, Professor Andrew Pollard, Chief Investigator, Oxford Vaccine Trial and Vice-Chancellor of Sri Ramachandra Higher Education and Research.
The notice seeking compensation says, the patient has allegedly gone through severe trauma after he was diagnosed with ‘Acute Neuro Encephalopathy’ which is allegedly an extreme side-effect of the vaccine that he took on October 1.
“Our client’s wife states that he is still not stable, has severe mood swings, has problems with comprehending and focusing on things, and is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters,” the notice read.
The patient has also alleged that even after a month of severe adverse reaction to the vaccine, the DCGI, ICMR, and SII allegedly did not get in touch with him for a follow-up.
In response, the Serum Institute has issued a statement stating that the allegations in the notice are malicious and misconceived. The SII statement reads, “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 statement further says, “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 is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India, will seek damages in excess of 100 crore for the same and will defend such malicious claims”, the SII statement concluded.