Amid concerns over the adverse event that was reported by a volunteer who participated in Serum Institute’s vaccine trialCovishield, the company today said that it won’t release its vaccine for mass use until it’s proven “safe and immunogenicity”.
The Pune-based vaccine manufacturer 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,” stated the firm.
As reported by ET, a volunteer allegedly suffered serious adverse event after he was administered with the vaccine.
A law firm representing a 40-year-old participant in the trials of Covishield had sent a legal notice to the company and the drug regulatory authority.
The notice said the participant suffered a serious adverse event after being administered the under-trial vaccine, and is demanding financial compensation of Rs 5 crore. The legal notice also alleged that despite this, no public disclosure was made
Serum today said that the incident was not vaccine induced. “The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer’s medical condition,” said Serum Institute in a statement issued on Tuesday.
Serum assured 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,” it further said.
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