The initial findings into the ‘adverse event’ allegedly suffered by an Oxford Covid-19 vaccine trial participant in Chennai did not necessitate halting of the trials, the Centre on Tuesday said even as Serum Institute of India (SII) on Tuesday asserted that the Covishield vaccine will not be released for mass use unless it is proven immunogenic and safe.
“It is the role of the drug regulator to ascertain or refute any causal link between the event and the intervention,” Union Health Secretary Rajesh Bhushan said at a press briefing here on allegation of the 'adverse event' in a SII trial. He added that it will not affect vaccine timelines in any way.
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 rejected the charges as "malicious and misconceived" and said it will seek damages in excess of Rs 100 crore. The company said the serious adverse event (SAE) that happened to the volunteer, though unfortunate, was in no way induced by the vaccine and asserted that the Covishield vaccine will not be released for mass use unless it is proven immunogenic and safe.
While replying to a query from reporters here at the presser, 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.
Bhushan added that he does not want to comment on specifics of the case as the matter was in court. “But it is seen that most of the discourse on adverse events in the 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 explained.
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 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 the 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 the Drugs Controller General of India (DGCI) about the event.
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, he said.
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.