New Delhi: An investigation launched by the Comptroller General of Drugs of India (DCGI) into an alleged “serious adverse event” suffered by an Oxford COVID-19
The participant of the vaccine trial in Chennai found that it was not related to the injection he was given, official sources said. The DCGI reached the conclusion Wednesday based on recommendations from a committee of independent experts that has also opined that compensation should not be paid to the volunteer, they said.
An independent expert panel consisting of a physician from AIIMS, Safdarjung Hospital, the Chandigarh Postgraduate Institute of Medical Education and Research, Lady Hardinge Medical College and Maulana Azad Medical College was constituted by DCGI to investigate 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 volunteered for the third phase of the vaccine trial in Chennaic claimed to have suffered severe neurological and psychological symptoms after receiving the experimental injection. He has sued the SII along with others and asked for Rs 5 million compensation, in addition to seeking the suspension of the trial.
However, the SII on Sunday rejected the charges as “malicious and ill-conceived” and said it would seek compensation of more than 100 million rupees. “The expert committee, after due deliberation, was of the opinion that the reported SAEs were not related to the vaccine / clinical trial. Therefore, the committee recommends that no compensation be paid to the subject’s legal heir / nominated subject,” the panel said in its recommendation.
Pune-based vaccine maker SII had said Tuesday that the vaccine is safe and immunogenic. “We want to assure everyone that the vaccine will not be released for mass use unless it is proven to be immunogenic and safe,” he blogged.
Union Health Ministry officials said Tuesday that the adverse event will not affect the vaccine release timelines in any way, at all. In addition, they affirmed that the due processes have been followed regarding the notification of the adverse event.
The director general of the ICMR, Dr. Balram Bhargava, was on Tuesday health, adverse events occur with drugs or vaccines or with any other health intervention. “If any adverse event warrants hospitalization, it is called a serious adverse event. It is the role of the drug regulator, after collecting all the data, to determine or refute whether there is a causal link between the event and the intervention.
“That causal link, whether it is to be verified or disproved, must be made by the DCGI and all documents related to it have been submitted to it accordingly for review,” Bhargava said. Emphasizing that it is done purely on a scientific basis and that the evaluation is done with very objectively based criteria, Bhargava had said that “the initial findings of the causality evaluation did not require the interruption of these trials.”
The Chennai-based business consultant was administered the opportunity at the Sri Ramachandra Institute for Higher Education and Research (SRIHER) in Chennai, one of the test sites on October 1. A law firm on his behalf sent on November 21 a legal notice to ICMR Director General, CEO, SerumInstitute of India Private Limited, Pune, Drugs Controller General of India, Central Drugs Standard Control Organization, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Tria and Vice Chancellor of Sri Ramachandra Higher Education and Research.
TTheSII has partnered with British-Swedish biopharmaceutical giant AstraZeneca AstraZeneca to manufacture the Oxford vaccine candidate for COVID-19.
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