Voluntary participation in clinical trials implies acceptance of inherent risks; compensation claims require direct attribution of adverse effects to the vaccine, which was not established.

ORDER

The side effects caused by the vaccine “COVIDSHIELD” for which the petitioner, as a volunteer, stood for human trial, and resultantly suffered neurological complications of the said vaccine resulting in adverse effects on the daily life of the petitioner, has led to the filing of the present writ petition for declaration to declare the said vaccine “COVIDSHIELD” as unsafe for humans and also for compensation for the damage caused to the petitioner.

2. It is the case of the petitioner that he is an independent business consultant and is married with two kids, aged 12 and 17 respectively. It is the further averment of the petitioner that as a socially conscious individual, the devastative effect of COVID-19 Pandemic was followed by the petitioner and on coming to know of the vaccine developed by the 4th respondent, viz., COVIDSHIELD, based on the permission granted by the 2nd respondent to conduct human trial to find out the safety and efficacy of the said vaccine, the trial of which was conducted at the 6th respondent University, the petitioner volunteered to take the vaccine on trial. It is the further averment of the petitioner that he approached the 6th respondent and the Principal Investigator informed him that the trial vaccine is found to be safe and, therefore the petitioner acceded to participate in the clinical trial after going through the participant information sheet, in which there was a categorical assertion about the safety of the vaccine. The petitioner gave his consent to be a volunteer and the vaccine was administered on 1.10.2020.

3. It is the further case of the petitioner that there was no adverse reaction for the first 10 days. However, on 11th October, 2020, the petitioner developed severe headache and was admitted at the 6th respondent Hospital, where he was put in ICU and he lost his memory. Various tests were done to find the cause, which tests returned a negative result, which clearly revealed that the adverse neurological disorder was on account of the vaccine administered to the petitioner on 1.10.2020.

4. It is the further averment of the petitioner that neither the 4th respondent nor the 6th respondent contacted him after his discharge from the hospital and the neurological disorder was on account of the adverse effect of the vaccine administered by the 4th respondent. Hence, the petitioner caused a legal notice dated 21.11.2020 to the 4th respondent claiming a sum of Rs.5 Crores as compensation and damages for the trauma suffered by him and his family due to the said vaccine. It is the further averment of the petitioner that he came to know that the 2nd respondent had formed an expert committee to look into the issue and the expert committee had submitted a report stating that the severe adverse reaction was not related to vaccine. Without hearing the petitioner, the expert committee has given its report, which is in violation of principles of natural justice. Hence, the petitioner was constrained to file the present writ petition alleging that the administration of the study vaccine and the after effects suffered by the petitioner was a serious adverse event as defined u/s 2 (ff) of the New Drug and Clinical Trial Rules (for short ‘Rules, 2019’) and, the present petition has been filed for the relief supra.

5. Learned counsel appearing for the petitioner contended that prior to the trial vaccine being given to the petitioner, all tests were done to the petitioner, which did not result in any adverse result, prompting the petitioner to be found fit for taking the trial of the vaccine. It is the further submission of the learned counsel that the petitioner had, on the basis of the participant information sheet accepted to be a volunteer, as the4th respondent had made a categorical assertion that the vaccine was safe to be tested for human trial. In fact, the participant information sheet has detailed that the side effect of the vaccine will be very mind.

6. It is the further submission of the lear