Chennai: In a setback to the development of COVID-19 vaccines in India, a 40-year-old man has sent a legal notice to Serum Institute of India (SII) and others seeking Rs 5 crore in compensation, and also sought a halt to the ongoing final-stage clinical trial.
The man, who took part in the Covishield vaccine trial in Chennai, has complained of serious side effects, including a virtual neurological breakdown and impairment of cognitive functions, PTI reported.
Alleging that the AstraZeneca-Oxford vaccine candidate — being produced by SII — was not safe, he has sought cancelling approval for its testing, manufacture and distribution, failing which legal action would be taken.
The Indian Council of Medical Research and Sri Ramachandra Institute of Higher Education and Research, where the vaccine was administered, have also been served the notice.
The man stated that he suffered acute encephalopathy, which affects the brain, after vaccination and that tests confirmed it was due to the vaccine.
The notice further stated that the trauma he underwent ‘clearly proves’ the vaccine was not safe, as the stakeholders had claimed, and also that they were trying to hide the adverse effects it has had on him.
A Sri Ramachandra Institute spokesperson said they had got the notice, but declined a comment.
The volunteer, who was administered the vaccine on October 1, didn’t show any side effect for the first 10 days. Then he had severe headache and vomitting.
He thereafter showed behavioural changes, not being able to recognise anyone or speak, and was totally disoriented. He was shifted to the ICU discharged at the family’s request on October 26.
At home, he was quite disoriented at times and unable to relate to things or work.
There has been no reaction yet from Drugs Controller General of India, Jenner Institute Laboratories of Oxford University, AstraZeneca UK and Professor Andrew Pollard, chief investigator, Oxford vaccine trial – all of whom have also been sent the notice.
