The family of a 40-year-old man who suffered a severely adverse reaction after participating in a clinical trial for COVISHIELD, a Covid-19 vaccine, are now suing Serum Institute of India (SII) demanding Rs 5 crores as damages. The family has served a legal notice to SII that is conducting the trial in association with the Indian Council of Medical Research (ICMR).
The notice is served to not only the CEO of SII and the Director General of ICMR, but also to the Drugs Controller General of India, CEO, Astra Zeneca UK as well as Professor Andrew Pollard Chief Investigator, Oxford Vaccine Trial (The Jenner Institute Laboratories University of Oxford) as well as Vice Chancellor Sri Ramachandra Higher Education and Research.
According to the SII website, “ICMR has funded the clinical trial site fees while SII has funded other expenses for COVISHIELD. At present, SII and ICMR are conducting Phase 2/3 clinical trial of COVISHIELD at 15 different centres, across the country. It has completed the enrolment of all 1600 participants on 31 Oct 2020. COVISHIELD has been developed at the SII Pune laboratory with a master seed from Oxford University/Astra Zeneca. The vaccine made in UK is currently being tested in large efficacy trials in UK, Brazil, South Africa and USA.”
The legal notice says that the participant is an independent business consultant and had signed up for the trial as he is “a public-spirited person and is concerned about the healthcare system in the society, particularly its impact on the poor and the disadvantaged.” It says, “The death of millions of people all over the world due to the attack of the Covid-19 virus has affected him emotionally” and that “when he came to know that there was a call for volunteers for the 3rd phase of the human trial in Sri Ramachandra Institute of Higher Education and Research (formerly called Sri Ramachandra Medical College & Research Institute – SRMC) for testing the Covid-19 vaccine developed by the Oxford University, UK, the public spirit in him wanted to volunteer.”
The notice says that it was frequent and repeated assertions that the vaccine was safe, that made the participant sign up for the trial and even sign a consent form on September 29, 2020. He was administered the vaccine on October 1, 2020.
The participant started experiencing severe headaches and nausea, on October 11, 2020 following which there was also a change in his behaviour. It says that “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.”
He was administered a Covid test, an MRI and a CT scan, along with several other tests that were conducted till he was discharged on October 26, 2020 “with the Discharge Summary stating that he had suffered ‘Acute Encephalopathy’. He says that in the 16 days that he was in the Hospital, almost all possible medical tests and investigations were done on him to connect his neurological set back to any of his earlier health condition, that is, to connect it to some factor other than the test vaccine that was administered on him on October 1st. But all the tests done on him was found to be negative, confirming that the setback in his health was due to the test vaccine he was administered on 1st October 2020, and not because of any prior health condition.”
The notice further says, “No one from the Hospital got in touch with him or his family to find out how he was. 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 (Astra Zeneca 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.”
The participant demands that “that any move to manufacture the said vaccine commercially and distribute it to the general public as a safe vaccine is totally dishonest and goes against the WHO guidelines, as also the safety norms laid down by the ICMR and the Government of India. Therefore, the approval, as also the manufacturing and distribution of the said vaccine, should be stopped immediately, until it has been categorically proved that it is safe for everyone to take the vaccine.”
The entire Legal Notice may be read here:
Meanwhile, SII has denied the charges in a statement issued on the subject saying, “The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer’s medical condition.”
SII’s entire statement may be read here:
Scroll.in reports that SII dubbed the charges “malicious” and “misconceived” and has filed a defamation suit for Rs 100 crores against the participant.
Government officials have also jumped to SII’s rescue. NDTV quoted Health Secretary Rajesh Bhushan as saying, “After initial causality assessment, findings did not necessitate stoppage of the Serum trials. SII vaccine trials have entered Phase 3. After reviewing all documents, SII has been given permission to conduct Phase 3 trials. Bharat Biotech also has been allowed to conduct Phase 3 trials.”
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