Serum Institute denies link between reported adverse event & COVID-19 vaccine

The Drug Controller General of India and the institutional ethics committee at the implementation site are investigating the adverse event as claimed to have been suffered by a trial participant in Chennai

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New Delhi: Addressing concerns related to the serious adverse event reported by a volunteer in Chennai, Serum Institute of India has called the ‘Covishield’ vaccine safe and immunogenic. As per the leading vaccine manufacturer, the incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and the company is sympathetic with the volunteer’s medical condition. The company is conducting trials for Oxford University and AstraZeneca’s COVID-19 vaccine in India.
In a statement, the company clarified 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.”
“We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe. Taking into consideration the complexities and existing misnomers about vaccination and immunization; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned,” read the statement issued on 1st December.
The Drug Controller General of India and the institutional ethics committee at the implementation site are investigating the adverse event as claimed to have been suffered by a trial participant in Chennai.
Earlier the 40-year-old volunteer who had participated in the third phase of the vaccine trials conducted at the Sri Ramachandra Institute of Higher Education and Research (SRIHER) site in Chennai claimed that the side-effects he faced included a virtual neurological breakdown and impairment of cognitive functions. He has sought financial compensation of Rs 5 crore and demanded that the vaccine’s testing, manufacturing, and distribution be halted immediately.