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".
A few days ago, a Chennai-based man had filed a legal notice, demanding compensation of Rs 5 crore from the SII after his health worsened allegedly after volunteering for the clinical trials for a COVID-19 vaccine. He claims that he has been diagnosed with "acute neuro encephalopathy", allegedly due to the Covishield shots he took on October 1. The participant had asked the ICMR, DCGI, AstraZeneca and Oxford University, along with SII to stop testing, manufacturing and distributing the vaccine.
Soon after that, Serum Institute had rubbished the claims, calling them malicious and misconceived. 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.
In a post on Tuesday afternoon SII reiterated its earlier comments, adding that while the incident was "highly unfortunate", it was in no way induced by the vaccine. It added that the concerned authorities had also cleared the organisation in this regard. It also explained that the legal notice had been sent "to safeguard the reputation of the company which is being unfairly maligned"
"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," a post on their Facebook page said.
The post noted that the Principal Investigator, DSMB and the Ethics Committee had "independently cleared and reckoned it as a non-related issue to the vaccine trial" Following this, the organisation said that all data pertaining to the incident had been submitted to the DCGI.
"It is only after we cleared all the required processes that we continued with the trials. We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe," the post adds.
