SII case against COVID-19 vaccine trial volunteer controversial; question of adverse events need to be addressed

The Serum Institute of India, which is conducting phase-third trials for a COVID-19 vaccine candidate in India, got into a controversy when it filed a lawsuit of Rs 100 crore against a trial volunteer.

The issue happened after a trial volunteer of Oxford-AstraZeneca Covishield vaccine reported adverse effects and medical conditions ten days after he was given the first dose.

The volunteer, who complained of memory loss and change in personality, sued the SII for a compensation of Rs 5 crores. The SII, in turn, filed a defamation lawsuit of Rs 100 crores against him on the pretext that his illness did not have anything to do with the vaccine trial.

The Institutional Ethics Committee (IEC) of the Covishield trials in India validated the same. The IEC, which is backed by the Data and Safety Monitoring Board (DSMB) and DCGI (Drugs Controller General of India), said that his symptoms were not from the vaccine shot.

Amid this controversy, the question of addressing such…

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