New Delhi: Stressing that the Covishield vaccine is "safe and immunogenic", the Serum Institute of India (SII) on Tuesday said the incident with the Chennai volunteer was in no way induced by the vaccine as "requisite regulatory and ethical processes and guideline" were followed strictly.
Addressing concerns related to the serious adverse event reported by a volunteer in Chennai, the statement by SII read, "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 Drugs Controller General of India. It is only after we cleared all the required processes that we continued with the trials," the statement read.
The Chennai-based man has demanded a compensation of Rs 5 crore from the SII after his health worsened allegedly after volunteering for the clinical trials for a COVID-19 vaccine.
The SII assured everyone that the vaccine will not 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," it added.
Responding to the man's claim that he suffered neurological and psychological side effects after taking a shot of COVID-19 vaccine candidate Covishield during the human trial, being conducted by SII, the Pune-based company had on Sunday said there was no correlation between the two, adding that it will seek damages in excess of Rs 100 crores for the same.