ICMR DG says initial assessment of Chennai volunteer case did not necessitate stoppage of 'Covishield' trials

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The Director-General of Indian Council of Medical Research (ICMR) Balram Bhargava on December 1 said the initial causal assessment of findings related to the Chennai clinical trial participant did not necessitate stoppage of Covishield vaccine trials.

Bhargava at a media briefing said the Institutional Ethics Committee (IEC), the Data safety and monitoring board (DSMB) and the Drug Controller General of India (DCGI) have done assessment objectively and the initial causal assessment findings did not necessitate stoppage of trials.

Rajesh Bhushan, Health Secretary said for the two serious adverse events reported with respect to vaccine trial of Bharat Biotech and Serum Institute of India, they have followed all the procedures. Bhushan said there are several layers to report adverse events these include Principal Investigator report on Form 5, IEC, DSMB and DCGI.

Bhushan declined any comment on the Chennai clinical trial volunteer serious adverse event case, saying the case is in the court.

Serum Institute had on Tuesday reiterated that the incident with the Chennai volunteer serious adverse event was in no way induced by the 'Covishield' vaccine and the company has followed all the requisite regulatory and ethical processes diligently before it went ahead with the trial.

Earlier, a 40-year old volunteer from Chennai whose name was kept confidential had alleged serious side effects, including a neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the testing, manufacturing and distribution of the vaccine. The participant was administered the vaccine at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites, on October 1.

The participant claimed in his notice that the vaccine administered on him on October 1 was indeed Covishield, and not a placebo, as this was established from a positive test for antibodies against Covid-19 done after he was admitted to the hospital on October 11. He was admitted 11 days after receiving the vaccination.

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