Covishield vaccine safe, volunteer’s illness not due to dose, clarifies Serum Institute

Mangalore Today News Network

Pune, Dec 01, 2020:     Amid concerns and doubts surrounding the AstraZeneca coronavirus vaccine that is undergoing trials in India in partnership with the Serum Institute of India (SII), the vaccine maker has now clarified that the illness referred by a volunteer was “in no way induced by the vaccine”.

 

In a statement on Tuesday, Serum Institute of India has said, “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 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,” the Pune-based vaccine maker has said further.

A Chennai-based volunteer who took part in the third phase of the coronavirus vaccine trial has filed a Rs 5 crore lawsuit against SII, AstraZeneca and others claiming serious side effects from the shot. The claim is now being investigated by the Drugs Controller General of India and the institutional ethics committee at the trial site.

Serum Institute has also said, they had 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,” SII has said.

“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,” SII has said, defending its Rs 100 crore defamation notice sent to the Chennai-based volunteer who said he had suffered neurological and psychological anomalies following a dosage of the vaccine candidate.

Courtesy:India Today