02 December,2020 10:29 AM IST | Chennai | Agencies
A health worker takes a swab sample from a woman at a temporary camp setup inside a public parking area in Mumbai. Pic/AFP
Vaccine development company Serum Institute, India on Tuesday said the Covidshield vaccine will not be released for mass use unless it is proven immunogenic, and safe. The company also said the serious adverse event (SAE) that happened to a city-based volunteer though unfortunate was in no way induced by the vaccine.
Serum Institute, which had earlier said it would claim over '100 crore damage from the volunteer for damaging its reputation, said it was sympathetic with the volunteer's medical condition and the incident is highly unfortunate.
"However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly," the company said. According to Serum Institute, the concerned authorities were informed and the principal investigator, Data Safety Monitoring Board (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 Drug Controller General of India. It is only after we cleared all the required processes that we continued with the trials," the company said.
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