DCGI finds no linkage between Covishield shot and volunteer’s adverse event during trial

An expert committee recommended that compensation should not be paid to the subject or legal heir/nominee of the subject

A probe initiated by the Drugs Controller General of India (DCGI) into an alleged “serious adverse event” reportedly suffered by an Oxford COVID-19 vaccine trial participant in Chennai has found that it was not related to the shot administered to him, official sources said.

The DCGI arrived at the conclusion based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.

An independent expert panel comprising a doctor each from AIIMS, Safdarjung Hospital, The Post Graduate Institute of Medical Education and Research, located in Chandigarh, Lady Hardinge Medical College and Maulana Azad Medical College was constituted by the DCGI to look into the claim of a ”serious adverse event” during the Serum Institute trial at a site in Chennai.

Last week, the 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.

“The expert committee after due deliberation opined that the reported SAEs were not related to vaccine/clinical trial. Therefore, the committee recommends a compensation not to be paid to the subject or legal heir/ nominee of the subject,” the panel said in its recommendation.

(Edits by EP News Bureau)

clinical trialCovid 19 vaccineCovishieldDCGISAEsserious adverse eventSII
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