After a Chennai-based man claimed that he suffered neurological and psychological side effects after taking a shot of Covid-19 Covishield vaccine during the human trial conducted by Serum Institute of India’s (SII), the Pune-based company claimed there was no correlation between the two.
In a social media post, the institute said, “Covishield is safe & immunogenic. The incident with the Chennai volunteer no way induced by the vaccine.”
Addressing the concerns related to the serious adverse events reported by a volunteer in Chennai, SII said, “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 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 DCGI. It is only after we cleared all the required processes that we continued with the trials.”
Addressing concerns related to the adverse event reported by volunteer in Chennai, Serum Institute of India shared;
— SerumInstituteIndia (@SerumInstIndia) December 1, 2020
SII further said that the vaccine won’t be released for mass usage unless it is proven immunogenic, and safe. “The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned: Serum Institute of India,” said SII.
Clinical trials of AstraZeneca-Oxford’s Covid-19 vaccine candidate in India are conducted by SII. Presently, the phase-3 clinical trial of Covaxin is being conducted across India involving 26,000 participants. The vaccine will be produced in the Bio safety Level 3 production facility of the company.
Covishield the vaccine candidate, is being developed by the UK’s Oxford University and US pharma giant AstraZeneca. The SII is a manufacturing partner for the vaccine.