Chennai: A 40-year-old Chennai resident, who had volunteered for the ‘Covishield’ vaccine human trial at a private hospital attached to a leading deemed-to-be-university, has reportedly suffered “neurological complications”.
Seeking Rs 5 crore compensation, his lawyers have issued legal notice to the private hospital in Chennai, the Pune-based drug maker Serum Institute of India, the manufacturing partner for Covishield,’ which is being developed by Oxford University, UK; and AstraZeneca, a US pharma giant.
However, Tamil Nadu Health Minister C Vijayabaskar has denied receiving any such complaint of adverse effect on volunteers of human trial for the COVID-19 vaccine. Nonetheless, his ministry would examine the issue.
A legal notice issued by Row & Reddy law firm, in which advocate NGR Prasad, a well-known civil and labour rights lawyer from Chennai works, said the man, who is a father of two young children, had volunteered for the human trial. While for 10 days after vaccination there was no adverse reaction, he developed neurological complications after getting up from bed with severe headache and nausea on October 11.
The legal notice was issued on the basis of his wife’s testimony. She had told lawyers that “there was a total behavioural change in him - he was not aware of his surroundings, he showed irritation towards light and sound, and was resisting any effort to make him get up from the bed.”
The man was subsequently admitted to the same private hospital “in an altered mental state” and “disoriented”.
The law firm has said that their client had volunteered for the trial only because he was “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.”
According to his wife, he is still under the adverse effect of the vaccine and is an agitated mood and frustrated.
However, Health Minister Vijayabaskar said there has been no side effect till now in the Covidshield vaccine trial, which is also being carried out by the Directorate of Public Health and Preventing Medicine and the Rajiv Gandhi Government General Hospital in Chennai. The Minister said the “immunogenicity” of the vaccine is being evaluated at the private hospital.
A spokesperson of the hospital refused to comment on the complaint.
This development comes on the heels of SII CEO Adar Poonawalla telling media outlets that the company will approach Indian regulators for emergency authorisation to use the vaccine within the next two weeks.
Responding to the volunteer’s claims, the SII said in a statement, “The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic to the volunteer’s medical condition, there is absolutely no correlation between 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 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,” the statement added.
SII went on to say, “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 Rs 100 crore for the same and will defend such malicious claims.”
Responding to the allegations, the head of the Epidemiology and Communicable Diseases (ECD) division of the ICMR, Dr Samiran Panda, told news agency PTI, "Any hurried inquiry or inference is prone to be wrong. Both the institutional ethics committee and the DCGI are investigating the causal links, if any, between the adverse events and investigational product, which is an anti-coronavirus vaccine."