A 40-year-old Chennai-based business consultant, who was a volunteer for the third phase of Oxford Covishield COVID-19 vaccine trial conducted by Pune-based Serum Institute of India (SII), has sought Rs.5 crore as compensation for allegedly suffering serious neurological and psychological symptoms after taking the dose.
The Drugs Controller General of India and the institutional ethics committee at the implementation site are investigating if the adverse event as claimed to have been suffered by the participant in Chennai are related to the shot administered to him. He was administered the shot at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.
A law firm from Chennai, on his behalf, has now sent a legal notice to Director General, ICMR, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator, Oxford Vaccine Trial and Vice Chancellor of Sri Ramachandra Higher Education and Research.
The man has sought compensation and demanded that the testing, manufacturing and distribution of the vaccine be stopped immediately.
As per the participant’s legal notice, there was no adverse reaction to the vaccine for the first 10 days. But on October 11, he allegedly began to experience a severe headache. He woke up at 5.30 am and then went back to sleep. According to his wife, she tried to wake him up again at 9 am and but he did not get up or speak to her. When he woke up at 2pm again he had a severe headache and vomited, as per the notice.
“Our client’s wife says that 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. She decided to take him to the hospital and called for the ambulance from Sri Ramachandra Medical College, as he could not even walk to the car, leave alone getting into it,” states the notice. “He vomited again inside the ambulance as he was taken to the Sri Ramachandra Medical College Hospital emergency ward. He was conscious but was not recognizing anyone nor speaking to anyone. He was sedated. He was very weak as he had not eaten any food the whole day. According to the Hospital’s discharge summary he was brought into the Hospital “in an altered mental state” and was “disoriented”,” it argues.
At the hospital, where he was admitted till October 29, according to the participant’s wife - he was dazed, lost in his thoughts, unable to talk or recognize people and even aggressive at times. He was unable to comprehend even basic conversations and recognize his children and wife. When he became marginally better, the family left the hospital but the 40-year-old is still allegedly struggling from symptoms of the virus.
“Our client states that the severe trauma he went through from 11th October 2020, because of the “Acute Neuro Encephalopathy” that he suffered, is an extreme side-effect of the test vaccine that he took on 1st October 2020. Our client’s wife states that he is still not stable, has severe mood swings, has problems with comprehending and focusing on things, is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters,” says the legal notice.
The participant further pointed out that neither the Drugs Controller General of India/ Data and Safety Monitoring Committee), the sponsors (ICMR and Serum Institute of India) or the collaborators of the sponsors (Astra Zeneca and Oxford University) got in touch with him to find out about the alleged severe adverse effect after vaccination and investigate the severe reaction the test vaccine has had on him
“Our client states that according to WHO, an adverse event should be reported immediately. A report must be made as quickly as possible so that immediate decision can be made on the need for action and investigation. The WHO guidelines further states that an immediate investigation of a severe adverse event attributed to vaccine, even if not causally related to it, is critical primarily for two reasons: ‘To respond to the community’s concern about vaccine safety and also to maintain public confidence in immunization’,” his counsel pointed out.
Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, said the causal link, if any, of the serious adverse events with the investigational product is objectively assessed in any clinical trial following a pre-defined scientific pathway and within a stipulated period.
"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," Dr Panda said.
The SII has partnered with British-Swedish biopharmaceutical giant AstraZeneca AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.
The DCGI had on September 11 directed Serum Institute of India (SII) to suspend any new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study.
However, on September 15 it permitted the Serum Institute of India to recommence the trial.
The notice given on November 21 by the law firm said, "Our client states that he must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in future."
"He further states that he is still far from being all right and has to be under medical care for a long time to come. Therefore, for all the trauma he is undergoing and with an uncertain future in his health, he should be given a financial compensation of Rs. 5 crores within two weeks from the receipt of this notice," it said.
The notice also said that testing, manufacturing and the distribution of the vaccine should also be stopped immediately, "failing which he has no other option except to take appropriate legal action against all the concerned parties, who would be made responsible for all the costs and consequences".
(With inputs from PTI)