SII said the incident with the Chennai volunteer was in no way induced by the vaccine as “requisite regulatory and ethical processes and guidelines” 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 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.
The Chennai-based man has sought 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 man claimed that he suffered neurological and psychological side effects after taking a shot of COVID-19 vaccine candidate Covishield during the human trial conducted by SII. The Pune-based company on Sunday said there was no correlation between the two, adding that it will seek damages in excess of Rs 100 crore for the same.
Replying to a legal notice sent by the volunteer on November 21, the SII said the allegations are malicious and misconceived. “While the Serum Institute of India is sympathetic to the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial.”
The SII said that the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. “It is evident that the intention behind the spreading such malicious information is an oblique pecuniary motive. The Serum Institute of India will seek damages in excess of Rs 100 crore for the same and will defend such malicious claims,” the vaccine manufacturer said.
The vaccine candidate, Covishield, is being developed by the UK’s Oxford University and US pharma giant AstraZeneca. The SII is a manufacturing partner for the vaccine.
In the legal notice, the participant asked the ICMR, DCGI, AstraZeneca and Oxford University, along with SII to stop testing, manufacturing and distributing the vaccine.