It is the role of drug regulator to ascertain or refute if there is any causal link between the event and the intervention, it said.
The initial findings into an ‘adverse event’ allegedly suffered by an Oxford COVID-19 vaccine trial participant in Chennai did not necessitate halting of the trials, the Centre said on Tuesday.
It is the role of drug regulator to ascertain or refute if any causal link between the event and the intervention, it said.
On allegation of the ‘adverse event’ in a Serum Institute of India trial, the government said it will not affect vaccine timelines in anyway.
A 40-year-old man who was a volunteer in the third phase of the ”Covidshield” vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions. He has sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial.
However, the SII on Sunday rejected the charges as “malicious and misconceived” and said it will seek damages in excess of Rs 100 crore.
ICMR Director General Balram Bhargava said adverse events occur with drugs or vaccines or any other health intervention.
“If any adverse event warrants hospitalisation 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 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 the five parameters have been submitted to him accordingly for review,” he said.
It is done purely on a scientific basis and the assessment is done with very objectively-based criteria and initial causality assessment findings did not necessitate stoppage of these trials, he added.
Responding to a question at a press conference, Union Health Ministry Secretary Rajesh Bhushan said, “The adverse event will not affect timelines in any manner whatsoever”.
Bhushan said he does not want to comment on specifics of the case but it is seen that most of the discourse on adverse events in media suffers from inadequate information and facts.
“Whenever a clinical trial starts the subjects are required to sign a prior informed consent form. This is a global practice which happens across countries,” he said.
Prior consent form tells the subject about the possible adverse events that may happen in case one decides to participate in a clinical trial, Bhushan said, adding that if one understand the implications of the prior informed consent then the form is signed by the subject.
Without the signature, a subject cannot participate in a clinical trial, he said.
“Secondly, these trials of vaccines or medicines they are multi site and multi centric they are conducted in multiple hospitals and multiple states. And at each site there is an institutional ethics committee which is independent of the vaccine manufacturer or the government,” Bhushan said.
He said that whenever in course of a trial any adverse event happens, this ethics committee takes note of it and within a period of 30 days gives a report to Drugs Controller General of India (DGCI) about the event.
“Then there is something known as data safety and monitoring board and this practice is a global practice followed across all countries. It is also independent of vaccine manufacturer and the government, and consist of domain experts and they also report on adverse events.
“The institutional framework for all clinical trials is provided by new drugs and clinical trials rules framed under drugs and cosmetics act of the country and it says that principal investigator (of the trial) will be responsible for giving report of DCGI,” he said.
The DCGI investigates if there is a one to one relation between the vaccine and the adverse event and then they permit it to go to another stage.
At present, SII vaccine trials are in phase 3 after all investigation, and Bharat Biotech clinical trials is also in phase 3 after all investigation.
On the statistics of COVID-19, Bhushan said in the last seven days, 211 cases per million population and two deaths per million population have been recorded in India.
“More than 14.13 crore COVID-19 tests have been conducted so far and the cumulative positivity rate has declined from from 7.15 per cent on November 11 to 6.69 per cent on December 1,” he said.
“On an average 10,55,386 COVID-19 tests were conducted daily and on average 43,152 new cases were reported daily in the month of November,” he added.