Initial assessment of adverse events didn’t necessitate stoppage of vaccine trials: ICMR

New Delhi, Dec 1 : The initial assessment of the two adverse events, which came to light recently during the clinical trials of two vaccine candidates — Covaxin and Covishield — did not demand stoppage of the trials, said Balram Bhargava, DG-ICMR, on Tuesday.
Meanwhile, the Union Health Ministry stated that “adverse events would not impact the timeline of vaccine rollout in any manner whatsoever”.
“It is important to remember that adverse events are bound to occur in drugs, vaccines or any other health interventions. It’s the role of the regulatory body, which in India is Drug Controller General of India (DCGI), to ascertain or refuse any causal link to the event and the intervention after collating all the data. The initial assessment of reported adverse events did not necessitate stoppage of the vaccine trials,” Bhargava stated while addressing a press briefing.
The statements have come in the wake of the two adverse events, one during the Phase I clinical trial of Bharat Biotech and ICMR sponsored Covaxin, and other during Phase I and II trials of the Serum Institute of India sponsored Covishield, which came to the light recently. The manufacturer and the volunteer, both have sent legal notices to each other in the matter.
In the case of Covishield, a Chennai-based volunteer was diagnosed with acute neuro-encephalopathy, which has allegedly been linked as a side-effect of the Covishield shots that he took on 1 October.
Initially, the volunteer sent a legal notice to the SII and demanded Rs 5 crore compensation for the neurological complications he developed after being administered the test dose. The company later denied the link between the complications and the vaccine dosage. In a counter, the SII also sent a legal notice to the volunteer demanding Rs 100 crore for damaging the company’s reputation through reporting an alleged serious adverse event which is unrelated to the test dose administration of Covishield that he underwent.