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COVAXIN update: Clinical trial of COVID-19 vaccine begins at NIMS Hyderabad

The Drug Controller General of India recently granted permission to initiate Phase I & II human clinical trials for COVID-19 Vaccine COVAXIN.

July 08, 2020 / 09:15 AM IST
3 | NHS England in talks on rollout of potential COVID vaccine from December, says report: The National Health Service (NHS) is in talks with the British Medical Association (BMA) and others around mobilising the rollout of a potential COVID-19 vaccine from December, Pulse website for health professionals reported. >There is optimism around the first cohorts being given a vaccine in December but there is a 50/50 chance of the vaccine being available by that time, Pulse reported, citing a person close to the discussions.

3 | NHS England in talks on rollout of potential COVID vaccine from December, says report: The National Health Service (NHS) is in talks with the British Medical Association (BMA) and others around mobilising the rollout of a potential COVID-19 vaccine from December, Pulse website for health professionals reported. >There is optimism around the first cohorts being given a vaccine in December but there is a 50/50 chance of the vaccine being available by that time, Pulse reported, citing a person close to the discussions.

The much-anticipated process of conducting clinical trials for a possible coronavirus vaccine, COVAXIN, began on Tuesday at the Nizams Institute of Medical Sciences (NIMS). ICMR’s National Institute of Virology and Bharat Biotech are jointly developing a vaccine against SARS-CoV-2, the virus that causes COVID-19.

"We will select healthy individuals and draw blood and send the blood samples to designated labs in New Delhi. They will give the green signal. Then the medicine people will examine and the first shot of the vaccine will be given due observation," NIMS director Dr K Manohar told PTI.

The Indian Council of Medical Research (ICMR) has identified 12 clinical trial sites such as medical institutions and hospitals, including NIMS, and has asked their principal investigators to ensure that the subject
enrolment is initiated no later than July 7.

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"Everything will be sent to ICMR, where data is analysed. We have already started the screening of individuals. We will first take audiovisual consent of the individual," the medical officer added. Asked about the total number of individuals required for the clinical trial, Manohar said at least 30 are needed.

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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The clinical trials proposal was already placed before the NIMS hospital ethics committee. The Drug Controller General of India recently granted permission to initiate Phase I & II human clinical trials for COVID-19 Vaccine COVAXIN.

ICMR had earlier announced that it aims to launch COVAXIN by August 15. "It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project," ICMR had said.

(With PTI inputs)

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Moneycontrol News
first published: Jul 8, 2020 09:14 am

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