Amid concerns over the adverse event that was reported by a volunteer who participated in Serum Institute's vaccine trial, the company has issued a statement saying that ‘Covishield’ 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," said Serum Institute in a statement issued on Tuesday.
The vaccine manufacturer clarified 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," stated the firm.
Serum assured 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 immunization, the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned," it said.
Raising serious concerns on the safety and transparency of 'Covishield' clinical trials, the participant has demanded a Rs 5 crore compensation on charges that after getting the vaccine shot, he experienced a neurological breakdown and an inability to get back to normal life.
The volunteer had participated in phase 3 clinical trials and has claimed the vaccine is “not safe” and that the testing, manufacture and distribution of the vaccine should be stopped.
Serum Institute, in turn, had threatened to seek damages in excess of Rs 100 crore from the volunteer.