Claims and counterclaims over alleged adverse reaction in covid-19 vaccine in India

The Indian manufacturer of the Oxford-AstraZeneca candidate vaccine against covid-19 (the Serum Institute of India) has threatened to claim Rs1bn (£10m; €11.2m; $13m) in damages from a clinical trial volunteer who alleges he developed a neurological illness after receiving the vaccine and has claimed Rs50m compensation. The Serum Institute of India, which is also conducting a clinical trial to assess the vaccine’s safety and immunogenicity in India, has said that the volunteer’s claim is “malicious and misconceived” because he was specifically informed by the medical team that the complications he suffered were independent of the trial. Indian health officials said on 1 December—over six weeks after the volunteer reported the illness—that probes by the institutional ethics committee, the data safety monitoring board, and India’s drug regulatory authority had found no correlation between the serious adverse event and the vaccine. Balram Bhargava, India’s department of health research secretary and director general of the Indian Council of Medical Research, said: “The initial causality assessment findings did not necessitate the stoppage of the trial.”