All processes followed, says DCGI on Serum Institute’s COVID-19 vaccine trials

An SAE is any untoward medical occurrence during the trial that may result in the volunteer getting hospitalised, suffers disability, or death. But the causality on whether the SAE is related to the clinical trial has to be established by an expert committee of DCGI for the compensation.

Serious adverse events

So far, two cases of SAEs have come to limelight related to COVID-19 vaccine trials. One is related to a 40-year-old volunteer from Chennai who had complained of serious side-effects, including a neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore as 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.

Serum Institute said the incident with the Chennai volunteer’s 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.

There was another case of SAE of a volunteer who participated in Bharat Biotech’s clinical trial in Mumbai, but the company said it wasn’t related to the experimental vaccine.

However, the Serum Institute’s alleged threatening of the participant, seeking damages in excess of Rs 100 crore, and the DCGI’s silence have drawn flak from public health experts.

Somani's statement comes days after the Director General of the Indian Council of Medical Research (ICMR) Balram Bhargava, too, said that the initial causal assessment of findings related to the Chennai clinical trial participant did not necessitate the stoppage of Covishield vaccine trials.

Bhargava said the Institutional Ethics Committee (IEC), the Data Safety and Monitoring Board (DSMB), and the DCGI have done the assessment objectively and the initial causal assessment findings did not necessitate a stoppage of trials.

Protecting clinical trial participants

Somani said the regulator gives topmost priority to protect the clinical trial participants.

In his presentation, he explained that the principal investigator or the doctor who is administering the trial will have to flag the SAE within 24 hours, the institution ethics committee (IEC) will have to report the SAE and send its opinion on whether there is a causal link between SAE and the trial within 30 days, and the sponsor of the trial will have report the SAE in 14 days.

Also the Drug Safety Monitoring Board (DSMB), with independent experts, will assess the SAEs and advise the DCGI on whether to pause the trial or not based on the causality of the SAE with the trial.

In addition, the DCGI also has an internal subject matter experts committee (SEC) that reviews the SAEs to advise the regulator.

The DCGI said more than Rs 12 crore has been given to volunteers in compensation in the past for cases related to serious adverse events.

He added that the regulator, in the past, had cancelled licences of 10-15 ethics committees, and suspended even more for not following rules.  Every clinical trial site has an ethics committee that approves and oversees the trial.