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COVID-19 update | DCGI finds no link between vaccine shot and 'adverse' reaction in Chennai volunteer during trial: Report

ICMR Director General Dr Balram Bhargava had on Tuesday said adverse events do occur with drugs or vaccines or any other health intervention.

December 02, 2020 / 10:12 PM IST
Representative image

Representative image

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.

Serum Institute says Covishield vaccine not the cause of Chennai volunteer adverse event, followed regulatory processes

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.

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COVID-19 Vaccine

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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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," 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,SerumInstitute 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 Trialand Vice Chancellor of Sri Ramachandra Higher Education and Research.

The SII has partnered with British-Swedish bio-pharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.
PTI
first published: Dec 2, 2020 10:12 pm

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