New Delhi: Health Secretary Rajesh Bhushan said on Tuesday that "adverse event" related to vaccine trial participant in Chennai will not affect the timelines and noted that a trial site has an institutional ethics committee which is independent of the manufacturer or government.
He said in case of an adverse event, the committee takes note and gives its report to Drug Controller General of India.
Bhushan was answering a question during a press conference about "adverse event" allegedly suffered by a Chennai volunteer who participated in Covishield vaccine trial against COVID-19.
"Adverse event will not affect the timeline in any manner whatsoever. Having said that let me also tell you there is court case regarding this, so we don't want to comment on the specific of the case. However, we believe that most of the discourse on adverse events in the media suffers from adequate information and adequate facts," he said.
Bhushan said whenever clinical trial starts, subjects are expected to sign a prior informed consent form. "This is a global practice, it happens across all countries. The form tells the subject about possible adverse events that may happen in case one decides to participate in the trial," he said.
Bhushan said clinical trials are multi-centric and multi-site.
"Each site has an Institutional Ethics Committee which is independent of the manufacturer or government. In case of any adverse event, this committee takes note and gives its report to Drug Controller General of India," he said.
Bhushan also said that the data safety monitoring board also monitors clinical trial on a day-to-day basis and keeps an eye on adverse events and reports it.
Drug Controller General analyses all reports and finds out whether there's a one-to-one co-relation between adverse events and vaccination, he said.
ICMR Director-General Dr Balram Bhargava said "adverse events do occur" with drugs or vaccines or any other health intervention.
"It is the role of the regulator after collating all data to ascertain or refute whether there is a causal link between the event and intervention," he said.
The Serum Institute of India (SII) on Tuesday said that Covishield vaccine is "safe and immunogenic" and the incident with the Chennai volunteer was in no way induced by the vaccine as "requisite regulatory and ethical processes and guideline" were followed strictly.
(ANI)
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