Covishield's approval process hinges on adverse event investigation

SII has in response stated that the allegations made in the legal notice are 'malicious and misconceived', and that it will seek damages in excess of Rs 100 crore.

The outcome of the in-depth investigation by the country’s drug regulator on the serious adverse event reported in a 40-year-old trial participant in Chennai will decide the future course of the approval process of the AstraZeneca-Oxford vaccine, said the country's apex health research institution. 

In October, a trial participant suffered a neurological illness (acute encephalopathy) and was hospitalised 10 days after he received the first jab of the vaccine in the Covishield trial. He sent a legal notice to the Serum Institute of India (SII), the sponsor of the trial, seeking Rs 5 crore in damages. 

SII has in response stated that