Volunteer's reaction not due to vaccine: SII

December 01, 2020 12:36

Statement from Serum Institute of India on the alleged reactions to the vaccine on a volunteer: "Covishield safe and immunogenic. Incident with the Chennai volunteer no way induced by the vaccine. All regulatory and ethical processes and guidelines were followed," Principal Investigator, DSMB & Ethics Committee stated it was non-related issue to vaccine trial.

The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned, the Serum Institute said.

A 40-year-old man who took part in the 'Covidshield' vaccine trial in Chennai 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 Serum Institute and others, besides seeking a halt to the trial.

Alleging that the candidate vaccine was not safe, he has also sought cancelling approval for its testing, 'manufacture and distribution', failing which legal action would be taken.

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