A 40-year-old man from Chennai, who was a participant in the Covishield vaccine trials for Covid-19, manufactured by the Pune-based Serum Institute of India (SII), has sought Rs. 5 crore compensation for allegedly suffering from serious 'neurological' side-effects after taking the experimental doses.

A law firm representing the participant has sent a notice to SII seeking compensation while the Drugs Controller General of India and the institutional ethics committee at the implementation site at Sri Ramachandra Medical University in Porur are investigating if the adverse event as claimed to have been suffered by a COVID-19 vaccine trial participant in Chennai are related to the shot administered to him.

Covishield is jointly developed by Oxford University and drugmaker AstraZeneca, and is also touted to be the frontrunner among other vaccines. SII has a tie-up with Oxford and AstraZeneca pharma company for the manufacturing of a billion doses in India.

The law firm has also sent the legal notice to 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.

According to the notice by the law firm, 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 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 and the notice alleged that this was against WHO standards.

Apart from financial compensation, the patient has also sought that “the testing, manufacturing and the distribution of the vaccine should also be stopped immediately.”

Meanwhile, the Serum Institute of India issued a statement saying, "SII is sympathetic with volunteer’s medical condition, there's absolutely no correlation with vaccine trial & his medical condition. He's falsely laying blame for his medical problems on trial. It is evident that the intention behind spreading of such malicious information is an oblique pecuniary motive. We will seek damages in excess of Rs 100 crores for the same and will defend such malicious claims".

When contacted, the Public Relations Officer of Ramachandra Institute, said the hospital is not making any comments as the issue is sub-judice.

The Drugs Controller General of India (DCGI) is reportedly investigating the claims of the volunteer.

Source: https://www.newindianexpress.com/cities/chennai/2020/nov/29/alleging-side-effects-from-covishield-vaccine-trials-chennai-based-volunteer-seeks-rs-5-crore-compen-2229651.html