Amid concerns and doubts surrounding the AstraZeneca coronavirus vaccine that is undergoing trials in India in partnership with the Serum Institute of India (SII), the vaccine maker has now clarified that the illness referred by a volunteer was “in no way induced by the vaccine”.
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. The claim is now being investigated by the Drugs Controller General of India and the institutional ethics committee at the trial site.
“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. 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. Serum Institute, in turn, had threatened to seek damages in excess of Rs 100 crore from the volunteer.