Panned for threatening affected participant with a Rs 100 crore defamation suit
Addressing concerns related to the serious adverse event (SAE) reported by a Chennai-based volunteer who was part of the Covishield clinical trial, Pune-based Serum Institute of India put out this statement on their official Twitter handle:
“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. However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly. The concerned authorities were informed and the Principal Investigator, DSMB and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial. Post which we submitted all the reports and data related to the incident to the DCGI. It is only after we cleared all the required processes that we continued with the trials.
We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe. Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned.”
As the trial is still ongoing, it is still not clear if the volunteer was part of the arm which received the candidate vaccine. The volunteer had filed a case for compensation of Rs 5 crore after he was hospitalised post vaccination due to deterioration health. Health experts have questioned why the DCGI had not paused the trial pending an investigation, as was done when similar SAEs had occurred in other COVID-19 vaccine trials across the world.
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