Adverse event will not affect the timelines says Rajesh Bhushan, Secretary, MOHFW

Health Ministry clarifies about recent complaints from Chennai based Volunteer against Serum Institute of India (SII) on Phase 3 clinical trials “Adverse event will not affect the timeline in any manner whatsoever.” Said Rajesh Bhushan, Secretary, Health Ministry

On enquiry in case some adverse event reported during the course of clinical trials Rajesh , Secretary, Health ministry said “Clinical trials are multi-centric & multi-site. Each site has an Institutional Ethics Committee, which is independent of manufacturer or govt. In case of any adverse event, this Committee takes note & gives its report to Drug Controller General of India.”

Serum Institute of India (SII) has also issued statement regarding safety issues of COVID-19 vaccine COVISHIELD

“The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and the Serum Institute of India is sympathetic with 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, 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.” says the statement by SII

Serum Institute of India (SII) has also assured in a statement about vaccine safety and credibility ” 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.”

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