Amid allegations that the Covishield vaccine had triggered severe neurological complications in one of the trial participants, the Serum Institute of India on Tuesday reiterated their statements that the vaccine was "safe and immunogenic".
After a Chennai-based man claimed that he suffered neurological and psychological side effects taking a shot of Covid-19 vaccine Covishield during the human trial being conducted by Serum Institute of India's (SII), the Pune-based company said 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."
The Pune-based company also said that it has sent a legal notice to a man who claimed he had developed serious side-effects in the human trials. “The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned,” news agency ANI quoted SII as saying.
In a statement, the Adar Poonawalla-led Institute also said 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,” it added.
A 40-year-old vaccine volunteer alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions.
The SII clarified that following the incident, they had submitted all reports and data related to the incident to the Drugs Controller General of India (DGCI).
“It is only after we cleared all the required processes that we continued with the trials,” said the SII.