Reaction in volunteer not linked to COVID-19 vaccine: Drug Authority

A probe initiated by the Drugs Controller General of India DCGI into an alleged serious adverse event reportedly suffered by an Oxford COVID19 vaccine trial participant in Chennai has found that it was not related to the shot administered to him official sources saidThe 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 saidAn 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 ChennaiLast week the 40yearold 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 trialThe SII however on Sunday rejected the charges as malicious and misconceived and said it will seek damages in excess of Rs 100 croreThe expert committee after due deliberation opined that the reported SAEs were not related to vaccineclinical 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 recommendationPunebased vaccine manufacturer SII had on Tuesday said that the vaccine is safe and immunogenicWe would want to assure everyone that the vaccine wont be released for mass use unless it is proven immunogenic and safe it said in a blogThe Union Health Ministry officials on Tuesday said that the adverse event will not affect the timelines of vaccineroll out in any manner whatsoeverThey further stated that due processes about reporting the adverse event have been followedICMR Director General Dr Balram Bhargava had on Tuesday said adverse events do occur with drugs or vaccines or any other health interventionIf 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 interventionThat 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 Bhargava saidStressing that it is done purely on a scientific basis and the assessment is done with very objectivelybased criteria Bhargava had said initial causality assessment findings did not necessitate a stoppage of these trialsThe Chennaibased business consultant was administered the shot at Chennais Sri Ramachandra Institute of Higher Education and Research SRIHER one of the trial sites on October 1A 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 ResearchThe SII has partnered with BritishSwedish biopharmaceutical giant AstraZeneca AstraZeneca for manufacturing the Oxford vaccine candidate for COVID19Keep scrolling to read more newsCatch up on all the latest Crime National International and Hatke news here Also download the new midday Android and iOS apps to get latest updates MidDay is now on Telegram Click here to join our channel middayinfomedialtd and stay updated with the latest newsThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever