Initial Assessment Of Adverse Events Didn’t Necessitate Stoppage Of Vaccine Trials: ICMR  

New Delhi, Dec 1 : The initial assessment of the two adverse events, which came to light recently during the clinical trials of two vaccine candidates — Covaxin and Covishield — did not demand stoppage of the trials, said Balram Bhargava, DG-ICMR, on Tuesday.

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Meanwhile, the Union Health Ministry stated that “adverse events would not impact the timeline of vaccine rollout in any manner whatsoever”.

“It is important to remember that adverse events are bound to occur in drugs, vaccines or any other health interventions.It’s the role of the regulatory body, which in India is Drug Controller General of India (DCGI), to ascertain or refuse any causal link to the event and the intervention after collating all the data.The initial assessment of reported adverse events did not necessitate stoppage of the vaccine trials,” Bhargava stated while addressing a press briefing.

The statements have come in the wake of the two adverse events, one during the Phase I clinical trial of Bharat Biotech and ICMR sponsored Covaxin, and other during Phase I and II trials of the Serum Institute of India sponsored Covishield, which came to the light recently.

The manufacturer and the volunteer, both have sent legal notices to each other in the matter.

In the case of Covishield, a Chennai-based volunteer was diagnosed with acute neuro-encephalopathy, which has allegedly been linked as a side-effect of the Covishield shots that he took on 1 October.

Initially, the volunteer sent a legal notice to the SII and demanded Rs 5 crore compensation for the neurological complications he developed after being administered the test dose.The company later denied the link between the complications and the vaccine dosage.

In a counter, the SII also sent a legal notice to the volunteer demanding Rs 100 crore for damaging the company’s reputation through reporting an alleged serious adverse event which is unrelated to the test dose administration of Covishield that he underwent.

In the case of Covaxin, Bharat Biotech, an adverse event in a volunteer occurred during the Phase I trials in August which the company did not promptly admit to the public.

The volunteer, with no comorbidities, developed viral pneumonitis.This occurred after he was given a dose of the Covaxin shot.

Meanwhile, Union Health Secretary Rajesh Bhushan clarified that the adverse events would not impact the timeline of Covid-19 vaccine rollout.However, he did not comment on two aforementioned adverse events.

Since the matter (of SII) is in legal course, we would not comment on the specifics but we want to ensure that the adverse events will not impact the timeline of vaccine rollout in any manner whatsoever,” he stated.

Without commenting on the ongoing trials by SII and Bharat Biotech despite the reportage of serious adverse events, Bhushan said that the trials by SII and Bharat Biotech have entered Phase III only after permission from all the regulatory bodies and frameworks.He also assured that a multi-disciplinary system is in place to report and act on such adverse events.

“Before trial, the subjects are taken through prior consent form which informs the subject about the possible adverse events that may happen during the course of trial.Only after signing the consent form, the subject is taken on board for the trial,” he said.

“The vaccine trials are multi centric and multi site.At each site, an institutional ethics committee is present which is independent from the government and the manufacturer.In case of an adverse event, the committee investigates and shares the findings with the DCGI.

Also, the Data Safety and Monitoring Board (DSMB), which is also independent and consists domain knowledge experts, intervenes in the occurrence of any adverse events.The conclusion about the authenticity of adverse events and its relation with the test dose is derived after the reports from these avenues by the DCGI,” Bhushan added

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