In the midst of a controversy surrounding a 40-year old Chennai subject in the clinical trial in India of the Oxford-AstraZeneca vaccine falling seriously ill and demanding Rs 5 crore in damages from Pune based Serum Institute of India (SII), the firm on Tuesday assured that the vaccine candidate Covishield is safe and that it would not be released for mass use unless proven 'immunogenic and safe'.
Addressing the concerns related to the adverse reaction reported by the volunteer in Chennai, SII said, "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."
The spokesperson added, "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, Drug Safety Monitoring Board (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."
SII further clarified that it was only after it 'cleared' all the required processes that it continued with the trial.
"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," the company added.
The DCGI is now carrying out an in-depth investigation of the documents submitted by SII.
The volunteer who suffered neurological illness and was hospitalised for more than a week had sent a legal notice to the company seeking Rs 5 crore in damages. His lawyers have indicated that the participant has not received any formal communication from the company saying that his illness (acute encephalopathy) is unrelated to the vaccine. Moreover, the law firm Advocates Row & Reddy and R Rajaram, who sent a legal notice on behalf of the 40-year-old individual, has claimed that the sponsor of the trial or SII has not borne the medical expenses he incurred. In response, SII had said that the allegations are 'malicious and misconceived' and that it would seek Rs 100 crore in damages.
Experts had found the response disappointing. Dr Shahid Jameel, senior virologist and director at Ashoka University told Business Standard that he found the response 'disappointing'.