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ICMR DG says initial assessment of Chennai volunteer case did not necessitate stoppage of 'Covishield' trials

Balram Bhargava at a media briefing said the Institutional Ethics Committee (IEC), the Data safety and monitoring board (DSMB) and the Drug Controller General of India (DCGI) have done assessment objectively

December 01, 2020 / 06:51 PM IST
Representative image

Representative image

The Director-General of Indian Council of Medical Research (ICMR) Balram Bhargava on December 1 said the initial causal assessment of findings related to the Chennai clinical trial participant did not necessitate stoppage of Covishield vaccine trials.

Bhargava at a media briefing said the Institutional Ethics Committee (IEC), the Data safety and monitoring board (DSMB) and the Drug Controller General of India (DCGI) have done assessment objectively and the initial causal assessment findings did not necessitate stoppage of trials.

Rajesh Bhushan, Health Secretary said for the two serious adverse events reported with respect to vaccine trial of Bharat Biotech and Serum Institute of India, they have followed all the procedures. Bhushan said there are several layers to report adverse events these include Principal Investigator report on Form 5, IEC, DSMB and DCGI.

Bhushan declined any comment on the Chennai clinical trial volunteer serious adverse event case, saying the case is in the court.

Serum Institute had on Tuesday reiterated that the incident with the Chennai volunteer serious adverse event was in no way induced by the 'Covishield' vaccine and the company has followed all the requisite regulatory and ethical processes diligently before it went ahead with the trial.

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COVID-19 Vaccine

Frequently Asked Questions

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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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Earlier, a 40-year old volunteer from Chennai whose name was kept confidential had alleged serious side effects, including a neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the testing, manufacturing and distribution of the vaccine. The participant was administered the vaccine at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites, on October 1.

The participant claimed in his notice that the vaccine administered on him on October 1 was indeed Covishield, and not a placebo, as this was established from a positive test for antibodies against Covid-19 done after he was admitted to the hospital on October 11. He was admitted 11 days after receiving the vaccination.

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Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Dec 1, 2020 06:51 pm

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