Chennai volunteer’s illness not due to COVISHIELD vaccine dose, clarifies SII

Team Udayavani, Dec 1, 2020, 3:57 PM IST

New Delhi: Vaccine major Serum Institute of India on Tuesday clarified that the illness referred by a Chennai-based volunteer was “in no way induced by the vaccine”.

“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,” read a statement issued by the Pune-based vaccine maker.

“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 statement added.

A 40-year-old Chennai-based business consultant, who was a volunteer for the third phase of the vaccine trial conducted by Serum Institute of India (SII), has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to SII and others, besides seeking a halt to the trial.

He was administered the shot at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites.

Rejecting the charges that AstraZeneca-Oxford’s COVID-19 vaccine candidate has serious side effects, Serum Institute on Sunday said that the volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial and it will seek damages in excess of Rs 100 crore for “malicious” allegations.

“The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer”s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer,” Serum Institute of India said in a statement.

“The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In-spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company,” Serum Institute said.

It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive, it added.

“The Serum Institute of India, will seek damages in excess of (Rs) 100 crore for the same and will defend such malicious claims,” the statement said.