A man from Chennai who participated in Serum Institute of India's (SII) Phase III clinical trials for its COVID-19 vaccine has sought ₹5 crores in compensation from SII alleging that he suffered neurological and psychological issues.
The 40-year-old has also asked the Central Drugs Standard Council of India (CDSCO), apex body for drug approval in India to halt the trials. He alleges that he was not informed about these serious side effects after voluntarily participating in the trial.
SII in a statement has said that it will file defamation charges for up to 100 crores against the participant as he went public even after the data and safety teams informed him that his health issues were not related to the Oxford-AstraZeneca vaccine.
The 40-year-old participant was a part of the trials at Sri Ramachandra Higher Education and Research (SRMC) in Chennai who received the shot on October 1. A law firm in Chennai representing the participant has sent a legal notice to Dr. Balrama Bhargava, Director General of the Indian Council of Medical Research, Adar Poonawala, CEO of SII, the CDSCO and the Drugs Controller General, CEO of AstraZeneca, Professor Andrew Polland, Chief Investigator of the Oxford Vaccine Trial, and the Vice Chancellor of Sri Ramachandra Higher Education and Research.
In the notice, the law firm claims that their client suffered disorientation and was admitted to SRMC Medical College on October 11. The notice further claims that the hospital discharged him on October 26 after diagnosing that he suffered from Acute Neuro Encephalopathy wherein he suffered mood alteration, memory loss, and altered behaviour. Tests conducted at the hospital to assess whether any other underlying health issues were responsible for the participant's mood swings, memory loss, and dizziness turned out to be all negative. This led to the participant and his wife to claim that these health conditions were due to the participant enrolling for the trials.
The participant further claims that he only participated in the trials as he wanted to help as the death of a million people across the world due to the pandemic worried him. The Participant Information Sheet that the patient filled only informs the participants about mild side-effects of the vaccine such as pain, tenderness, redness, warmth, itch, swelling, hardening, fever, chills, fatigue, feeling of discomfort, headache, joint pain, muscle pain, nausea, and allergy.
In the notice, the participant seeks compensation and halting of the trials, as the Participant Information Sheet discusses that the vaccine is safe and immunogenic but fails to mention about the adverse side effects apart from contracting COVID-19. As a result, the participant claims that the trials in India are not following the protocols of the Adverse Events Following Immunization (AEFI) set by the World Health Organization. Neither the hospital, nor the governing authorities of the clinical trials have followed-up with him after he was discharged, claims the participant.
Furthermore, the participant's wife has alleged that even after a month of being discharged, the patient still has mood disorders and his mood has altered completely. His information processing and concentration skills have also suffered a setback. EEG tests done on November 12 show "dysfunction involving both hemispheres", and "dysfunction involving the ascending sensory pathways on both sides from both the lower extremities" while psychiatric evaluation shows "mild deficit in verbal & visual memory functions", "mild deficit in dealing with complex information", and "an under-functioning in overall cognitive functions".
What Do The Authorities Say
The CDSCO and Data Safety Monitoring Body who were investigating the report that they received from SRMC have so far not found any links to the vaccine. Dr. Samiran Panda, head of the Epidemiology and Communicable Diseases (ECD) division, Indian Council of Medical Research told PTI that according to protocol, the principal investigator at the trial site has to investigate the issue first. This would be followed by an enquiry by the Institutional Ethics Committee at the trial site. ICMR as they are also participating in the trial have informed the DCGI, about the adverse event.
SII has released a statement stating that they will be filing defamation charges against the participant. The statement reads, "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 medi(c)al 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.
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."
Not The First Time Around For The CDSCO
While the CDSCO and Data Safety Monitoring Board for SII is investigating the trials, this is the second instance wherein the CDSCO has not halted trials for adverse events reported in India. According to reports, the CDSCO did not even ask for the halting of Bharat Biotech's Covaxin for an adverse event reported in August.
The CDSCO, however, did halt the trials when the Oxford-AstraZeneca trials were halted in the UK. From September 12 to September 15, SII had to halt their trials in the country.
Currently, the Phase III trials of Covishield are being conducted at 17 locations across India.
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