New Delhi | Jagran News Desk: The Serum Institute of India (SII) on Tuesday asserted that their coronavirus vaccine 'COVISHIELD' is "safe and immunogenic" and said that the incident with the Chennai volunteer was in no way induced by the vaccine as "requisite regulatory and ethical processes and guideline" were followed strictly.
"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," SII's statement reads.
"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 Drugs Controller General of India. It is only after we cleared all the required processes that we continued with the trials," the statement added.
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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 said.
A Chennai-based volunteer, on whom the vaccine was administered, had last week demanded 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.
Responding to the volunteer's claims that he suffered neurological and psychological side effects after taking a shot of COVISHIELD, the SII had on Sunday said that there was no correlation between the two, adding that it will seek damages in excess of Rs 100 crores for the same.
"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 had said.
The SII had stated that the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. Despite specifically being made aware of the same, the volunteer still chose to go public and malign the reputation of the company, the SII had added.
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.
(With ANI Inputs)