After a Chennai man claimed he suffered neurological and psychological side effects from receiving an injection of the Covid-19 Covishield vaccine during the human trial being conducted by the Serum Institute of India (SII), the company based in Pune said there was no correlation between the two. In a post on social media, the institute said: “Covishield is safe and immunogenic, the incident with the Chennai volunteer was not induced in any way by the vaccine.”
Addressing concerns related to the serious adverse event reported by a volunteer in Chennai, SII said: “Serum Institute of India is sympathetic to the medical condition of the volunteer. However, we would like to clarify that all regulatory processes and guidelines were followed and Ethics required diligently and strictly. Interested authorities were informed and the Principal Investigator, DSMB and the Ethics Committee independently clarified and considered it a problem not related to the vaccine trial. As we submitted all reports and data related to the incident at DCGI. It is only after we erase all required processes that we continue testing. “
The IBS further stated that the vaccine will not be released for mass use unless it is shown to be immunogenic and safe. “The legal notice was sent to safeguard the reputation of the company that is being unjustly defamed: Serum Institute of India,” said SII.
IBS is conducting clinical trials of AstraZeneca-Oxford’s Covid-19 vaccine candidate in India. Currently, the phase 3 clinical trial of Covaxin is taking place across India with 26,000 participants. The vaccine will be produced at the company’s Biosafety Level 3 production facilities.
The candidate vaccine, Covishield, is being developed by the UK’s University of Oxford and the US pharmaceutical giant AstraZeneca. IBS is a vaccine manufacturer partner.
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