Chennai, Nov 29: A Chennai-based man has demanded compensation of Rs 5 crore from Pune-based drugmaker Serum Institute of India (SII) as his health allegedly worsened after volunteering to take part in the clinical trials for a Covid-19 vaccine.
The vaccine ‘Covishield’ is being developed by UK’s Oxford University and US pharma giant AstraZeneca. SII is a manufacturing partner for the vaccine.
The Chennai resident, who is married and has two kids, volunteered for the third phase of the human trial for the vaccine at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER).
He urged the Indian Council of Medical Research (ICMR), the country’s top body for overseeing medical research, to not approve the vaccine.
SII did not immediately respond to Business Standard’s request for comment.
In early September, India’s central drug regulator had issued a show-cause notice to SII for not informing about its vaccine partner AstraZeneca pausing the clinical trials of the vaccine in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.
The show-cause notice was issued following reports that human trials of the most promising Covid-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a UK participant had an adverse reaction to it.
Advocates Row & Reddy and R Rajaram, who sent a legal notice on behalf of the 40-year-old individual have confirmed the development.
The notice, a copy of which is available with Business Standard, was sent to the CEO of Serum Institute of India (SSI), the Drugs Controller General of India (DGCI), AstraZeneca’s CEO, and the vice-chancellor of SRIHER.
He was informed that he was participating in a randomised controlled study to determine the safety and immunogenicity of the Covid-19 vaccine ‘Covishield’ in the health of Indian adults. The sponsors were SII and the ICMR.
Quoting the ‘participant information sheet’, the notice said the vaccine had previously been tested in about 500 adults of 18-55 years of age in the UK and was found to be safe and was found to induce an immune response.
“….he was therefore led to believe that taking the Covishield test vaccine was safe and the risks associated with taking the said vaccine would hardly lead to any serious side effect, leave alone the severe adverse effect he has had to painfully endure,” the notice said.
Currently, three large clinical trials in thousands of healthy adults are underway for this vaccine in the UK, Brazil, and South Africa.
The notice claimed that the side effects or after effects described in the participant information sheet were a far cry from those experienced by the man.
The Covishield vaccine was administered to him on October 1. Ten days later he experienced severe headaches and vomiting, the notice said. He was later admitted to SRIHER.
According to the hospital’s discharge summary, he was brought in “in an altered mental state” and was “disoriented”.
He was finally discharged from the hospital on October 26.
The volunteer’s wife claims that the situation did not improve much and he continued to be in an agitated mood, frustrated, unable to work, and was consulted with a psychiatrist. He took all tests and the results were negative.
The notice claims that the discharge summary of the hospital stated he had suffered “acute encephalopathy”.
It was also alleged in the notice that even after a month of the severe adverse reactions to the vaccine, neither have the regulator (Drugs Controller General of India/ Data and Safety Monitoring Committee), the sponsors of the trial (ICMR and SII) or the collaborators of the sponsors (Astra Zneca and OXford University) got in touch with him to find out about the severe adverse effect after vaccination and investigate the severe reaction the test vaccine has had on him.
Covishield is yet to undergo testing for its safety and its ability to work in India.