With the Chennai vaccine trial volunteer issue compounding into a big issue, the Pune-based Serum Institute of India (SII), which is world’s largest vaccine-maker, on Tuesday clarified that the Covishield vaccine is safe and immunogenic. The company has assured that the vaccine won’t be released for mass use unless it is proven immunogenic and safe.
The Chennai-based 40-year-old volunteer, who is a married male with two children, has sought Rs 5 crore as compensation for the neurological complications that he developed after being administered the dose during the trials. However, the SII has reacted with a Rs 100 crore defamation suit against the volunteer.
The SII has partnered with European drug manufacturer AstraZeneca and the University of Oxford to produce the Covishield vaccine in the country.
Providing clarification on the Chennai case, the SII said that the incident with the Chennai volunteer, though highly unfortunate, was in no way induced by the vaccine and the company was sympathetic to 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. The concerned authorities were informed and the Principal Investigator, Data and Safety Monitoring Board and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial,” said the SII in a statement.
“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,” it said.
“Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent therefore to safeguard the reputation of the company, which is being unfairly maligned,” the statement said.
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