Covid vaccine won't be released unless proven safe, assures Serum Institute

SII says after DSMB and ethics committee cleared they continued with the trials; sympathetic with the condition of the subject

In the midst of a controversy surrounding a 40-year-old Chennai subject in the clinical trial 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 its vaccine candidate Covishield would not be released for mass use unless proven ‘immunogenic and safe’. 

Addressing the concerns related to the serious adverse event reported by a volunteer in Chennai, SII said: “The incident with the Chennai volunteer, though highly unfortunate, was in no way induced by the vaccine, and SII is sympathetic with the volunteer's medical condition.” 

Meanwhile, the spokesperson for SII said: “However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly. The authorities concerned were informed and the principal investigator, Drug Safety Monitoring Board, and the ethics committee independently cleared it as a non-related issue to the vaccine trial, after which we submitted all the reports and the data related to the incident to the Drugs Controller General of India (DCGI).” 

SII further clarified 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 to safeguard the reputation of the company, which is being unfairly maligned,” the company added. 

The DCGI is now doing 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. His lawyers had indicated that the participant had not received any formal communication from the company saying his illness (acute encephalopathy) was unrelated to the vaccine. 

Moreover, the law firm Advocates Row & Reddy and R Rajaram, which sent a legal notice on behalf of the 40-year-old individual, had claimed that the sponsor of the trial (or SII) had not borne the medical expenses he had incurred. In response, SII said the allegations were ‘malicious and misconceived’ and that it would seek Rs 100 crore in damages. 

Dr Shahid Jameel, senior virologist and Director at Ashoka University, told Business Standard that he found the response ‘disappointing’. 

Patient advocacy groups raised concerns, alleging the volunteers who were given the shots after the adverse event were not informed about the event and what happened to one of the participants.