Serum Institute while addressing the queries in relation to the adverse reaction reported by the volunteer in Chennai, SII announced, the Covishield vaccine is safe and immunogenic.  The  highly unfortunate incident with the Chennai volunteer though was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition. 

The SII assured on Tuesday, that release for mass use will be done only if the vaccine is proven 'immunogenic and safe'. The SII spokesperson said, "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, Drug 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 DCGI."

"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 immunisation; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned," the company added. The DCGI is now undergoing an in-depth investigation of the documents submitted by SII. 

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