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Serum Institute Fracas Exposes Loose Ends of India s Clinical Trial Machinery

Serum Institute Fracas Exposes Loose Ends of India s Clinical Trial Machinery Participants voices are missing from deliberations about how officials should address serious adverse events in clinical trials. Representative photo: NCI/Unsplash. Health11/Dec/2020 Bengaluru: In November, two leading Indian COVID-19 vaccine manufacturers, Bharat Biotech and Serum Institute of India (SII), found themselves embroiled in controversy. Media reports alleged that there had been a “serious adverse event” in phase 1 of Bharat Biotech’s clinical trials for Covaxin. Phase 1 tests the safety of a new drug or vaccine in human subjects for the first time. Then, a 40-year-old man in Chennai, through a legal notice to SII, sought compensation of Rs 5 crore for an illness he alleged appeared after he participated in a clinical trial for Covishield, SII-made version of University of Oxford and AstraZeneca’s COVID-19 vaccine candidate.

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