Days after a Chennai man, who volunteered to take part in the clinical trials of vaccine candidate Covidshield, sent a legal notice to Serum Institute of India (SII) alleging that the vaccine triggered “severe adverse reaction” in him and sought compensation of Rs 5 crore, the Pune-based firm on Sunday said the allegations were “malicious” and that his medical condition was not linked to the vaccine trial.
The company said it will seek damages in excess of Rs 100 crore.
Chennai-based advocates N G R Prasad and R Rajaram sent the legal notice to SII—which is collaborating with AstraZeneca and Oxford University to develop the vaccine—on behalf of the participant on November 21.
The notice said, “Our client states that it is very disappointing and shocking to note that after his discharge from the hospital, there has been no follow-up…. Even after a month of the severe adverse reaction to the vaccine, neither have the regulator (Drugs Controller General of India/ Data and Safety Monitoring Committee), the sponsors (ICMR and Serum Institute of India) or the collaborators of the sponsors (AstraZeneca 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.”
On Sunday, the SII said in a statement: “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 said 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 said.
The principal investigator of the trial site told The Indian Express, “I can confirm that we reported the case to concerned authorities; in this case, it is the ethics committee and the DGCI. All the protocols have been followed.”
Tamil Nadu Health Minister C Vijayabaskar said the government will probe the issue. “We have been closely monitoring all of them and there were no side-effects reported so far… We will probe on this particular case reported now,” he said.
According to the legal notice, the participant had “no adverse reaction for the first 10 days after the vaccination”. But on October 11, he woke up with severe headache and went back to sleep. “Our client’s wife says there was a total behavioural change in her husband – 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 bed,” it said.
The notice said the participant was discharged on October 26, with discharge summary stating that he had suffered “Acute Encephalopathy”. The notice alleged in the 16 days that he was in hospital, “almost all possible medical tests and investigations were done on him to connect his neurological setback to any of his earlier health condition”. But all tests returned negative.
Apart from the SII, the notice was sent to AstraZeneca and Oxford Vaccine Group with copies to WHO. It demanded the vaccine trial, which is currently being tested on about 1,600 volunteers in India, be halted immediately.
— With ENS, New Delhi
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