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 on Wednesday 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.
Pune-based vaccine manufacturer SII had on Tuesday said that the vaccine is safe and immunogenic.
“We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe,” it said in a blog.
The Union Health Ministry officials on Tuesday said that the adverse event will not affect the timelines of vaccine-roll out in any manner, whatsoever.
They further stated that due processes about reporting the adverse event have been followed.
ICMR Director General Dr Balram Bhargava had on Tuesday said adverse events do 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 the 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 it have been submitted to him accordingly for review,” Mr Bhargava said.
Stressing that it is done purely on a scientific basis and the assessment is done with very objectively-based criteria, Bhargava had said “initial causality assessment findings did not necessitate a stoppage of these trials”.
The Chennai-based business consultant was administered the shot at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.
A law firm on his behalf on November 21 sent a legal notice to Director General of ICMR, CEO, Serum Institute of India Private Limited, Pune, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator of Oxford Vaccine Trial and Vice Chancellor of Sri Ramachandra Higher Education and Research.
The SII has partnered with British-Swedish biopharmaceutical giant AstraZeneca AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.
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