Initial findings into Serum Institute 'adverse event' did not necessitate halting of trials: Govt

The Union Health Ministry further said that the 'adverse event' during the Serum Institute of India (SII) trial was being reviewed by the Drugs Controller General of India (DCGI) to ascertain if there is any causal link between the event and the shot administered to him.

Last week, a 40-year-old man, who was a volunteer in the third phase of the vaccine trial in Chennai, claimed to have suffered serious neurological and psychological symptoms after taking the experimental shot. He has sued the SII along with others and sought compensation of Rs 5 crore, besides seeking a halt to the trial.

The SII, however, on Sunday rejected the charges as "malicious and misconceived" and said it will seek damages in excess of Rs 100 crore.

Also Read: Serum Institute Plans Rs 100 Crore Case Against Covishield Trial Participant Who Sought Rs 5 Crore Alleging Serious Side Effect

The Pune-based vaccine manufacturer on Tuesday said that the vaccine is safe and immunogenic.

"We would want to assure everyone that the vaccine won't be released for mass use unless it is proven immunogenic and safe," it said in a blog.

When asked to comment over the incident, Union Health Secretary Rajesh Bhushan at a press briefing on Tuesday said that due processes have been followed about reporting the 'adverse event'.

"We have been given to understand that there is a court case so we would not want to comment on the specifics of the case," he said asserting, "the adverse event will not affect timelines in any manner, whatsoever."

ICMR Director General Balram Bhargava said adverse events occur with drugs or vaccines or any other health intervention.

"If any adverse event warrants hospitalization then it is called a serious adverse event. It is the role of the drug regulator, after collating all the data, to ascertain or refute whether there is a causal link between the event and the intervention.

"That causal link, whether it has to be ascertained or refuted, has to be done by the DCGI and all the papers in connection to all five parameters have been submitted to him accordingly for review," Bhargava said.

Stating it is done purely on a scientific basis and the assessment is done with very objectively-based criteria, Bhargava said "initial causality assessment findings did not necessitate a stoppage of these trials", he added.

Bhushan further stressed that countering disinformation around vaccine was not just the responsibility of the Union and state government but also of the media and vaccine manufacturers.

He further said the Union Health Ministry would shortly come out with a guidance document that will address the issues around vaccine safety.

Elaborating on the procedures followed in case of an adverse event during a clinical trial, Bhushan said that whenever a clinical trial starts the subjects are required to sign a prior informed consent form which tells them about the possible adverse events that may happen during the trial.

Without the signature, a subject cannot participate in a clinical trial, he said.

Secondly, these trials of vaccines or drugs are multi-site and multi-centric which means they are conducted across multiple hospitals and various states and the subjects are given the shots under medical supervision and are monitored.

"And at each trial site there is an institutional ethics committee which is independent of the vaccine manufacturer or the government," Bhushan said.

"Whenever in the course of a trial any adverse event happens, this institutional ethics committee takes note of it and within a period of 30 days gives a report to the Drugs Controller General of India (DGCI) about the event as well as its comments on that event," Bhushan said.

Then there is something known as the DataSafety and Monitoring Board (DSMB) and this is a global practice followed across all countries. It is also independent of the vaccine manufacturing company and the government, and consists of domain experts who monitor the clinical trial on a day-to-day basis and they also report on adverse events, he said.

The institutional framework for all clinical trials is provided by new Drugs and Clinical Trials rules framed under the Drugs and Cosmetics Act of the country and it says that the principal investigator (of the trial) will be responsible for giving a report of DCGI in case of an adverse event, he said.

"Then the DCGI examines and investigates if there is a one to one relation between the shot administered and the adverse event, and only after reaching a conclusion they permit it to go to the next phase of the trial," Bhushan said.

At present, SII vaccine trials have entered phase 3 after all investigations and the clinical trials by Bharat Biotech have also entered phase 3 after all investigations.

On the government's perspective on the hesitancy among people to take the vaccine in light of adverse events being reported, Bhushan said there is an inherent issue of vaccine hesitancy which may have nothing to do with adverse events.

Asked if the government has decided on whether those having antibodies or those who have had COVID-19 would be inoculated or not, he said one of the mandates of the national expert group on vaccine administration is also to see whether people who are to be vaccinated should be tested for antibodies or not. "No final decision has been taken in this regard.