Covishield safe, immunogenic; incident with volunteer no way induced by vaccine: SII

 newindianexpress.com  12/01/2020 08:05:32 

NEW DELHI: Stressing that the Covishield vaccine is "safe and immunogenic", the Serum Institute of India (SII) on Tuesday said the incident with the Chennai volunteer was in no way induced by the vaccine as "requisite regulatory and ethical processes and guideline" were followed strictly.

Addressing concerns related to the serious adverse event reported by a volunteer in Chennai, the statement by SII read, "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. Post which we submitted all the reports and data related to the incident to the Drugs Controller General of India. It is only after we cleared all the required processes that we continued with the trials," the statement read.

The Chennai-based man has demanded a compensation of Rs 5 crore from the SII after his health worsened allegedly after volunteering for the clinical trials for a COVID-19 vaccine.

The SII assured everyone that the vaccine will not 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," it added.

Responding to the man's claim that he suffered neurological and psychological side effects after taking a shot of COVID-19 vaccine candidate Covishield during the human trial, being conducted by SII, the Pune-based company had on Sunday said there was no correlation between the two, adding that it will seek damages in excess of Rs 100 crores for the same.

On a legal notice sent by the volunteer on November 21, the SII had said the allegations are malicious and misconceived.

"While the Serum Institute of India is sympathetic to the volunteer's medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial."

The SII had stated that the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent.

"It is evident that the intention behind the spreading such malicious information is an oblique pecuniary motive. The Serum Institute of India will seek damages in excess of Rs 100 crore for the same and will defend such malicious claims," the vaccine manufacturer had said.

Despite specifically being made aware of the same, the volunteer still chose to go public and malign the reputation of the company, the SII had added.

The participant, according to the legal notice, has been diagnosed with "acute neuro encephalopathy", which has allegedly been linked with the Covishield shots he took on October 1.

The vaccine candidate, Covishield, is being developed by the UK's Oxford University and US pharma giant AstraZeneca. The SII is a manufacturing partner for the vaccine.

In the legal notice, the participant asked the ICMR, DCGI, AstraZeneca and Oxford University, along with SII to stop testing, manufacturing and distributing the vaccine.

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