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COVID-19 vaccines in Indian human trials: What are they?

The news of the novel coronavirus vaccine entering the human trials is heard everywhere. But what does this mean? What are human trials, and how long does it last? What all is expected during these trials?

Do you also have such questions? If yes, look no further. This article details everything you need to know about human trials for the COVID-19 vaccine.

So, let’s begin!!

Vaccine Testing Process

Any vaccine undergoes the following stages before it is ready to be distributed.

Pre-Clinical Stage

Before going into the human trial, the vaccine is tested in a lab on animals. This is known as the pre-clinical stage. During this stage, it is understood whether the vaccine is safe to be tested on humans.

Researchers also have an eye for signs that indicate the vaccine is working. If the pre-clinical stage is successful, it is then put before the Drugs Controller General of India, which is the regulatory body for the approval of human trials.

Human Trials

They are experiments of vaccines or drugs on human beings. It is a part of the clinical development phase of the vaccine. Here the vaccine is given on a healthy person to:

  • Understand if the vaccine is safe

  • Know if the vaccine acts the way it is intended to

Phases in the Human Trial

You may have heard that different vaccines are in different phases of human trials. Let’s understand what those phases mean.

  • Phase I: The primary aim of this phase to check if humans can tolerate the vaccine and it is safe. Here the researchers also look for initial signs of the immune response.

  • Phase II: Here, the focus changes to check the efficacy of the vaccine to bring out the desired immune response. Researchers also look to find an appropriate dose that produces the desired immune response. People taking part in trials are looked for as expected side-effects.

  • Phase III: In this phase, the findings of phase II are confirmed. Researchers also try to understand the protection provided by the vaccine. At this stage, the safety and efficacy of the vaccine are triple-checked. After this stage, the vaccine is ready to be used and is made available for public use.

  • Phase IV: Here, researchers keep an eye on the impact of the vaccine. Its efficacy and safety are continuously monitored in the real world.

What is the Number of Participants That Can Participate in Human Trials?

Usually, the number of participants depends on the phase and are as follows:

  • Phase I: Around 20 – 100 participants

  • Phase II: It can include around several hundred people

  • Phase III: Here thousands of participants can be involved

  • Phase IV: It will have several thousand people

Need for Human Trials

The human body works differently than animals. So, to understand the effects of a vaccine, the only way to know is to test it on humans. It also helps to understand if the vaccine has any side-effects.

Regulation of Human Trials

In India, the Indian Council of Medical Research (ICMR) provides extensive guidelines for human trials. “National Ethical Guidelines For Biomedical And Health Research Involving Human Participants” is a document in the guidelines that take care of every aspect while conducting a human trial.

The Ministry of Health’s Central Drugs Standard Control Organisation is the regulatory body that supervises human trials in India. This body takes the final decision of the approval of a vaccine validated for human trials.

At the primary level, the Ethics committee supervises every human trial. This committee works at a level of the medical institution, which is a hospital or a college. In case the trial takes place at a non-medical location, a nearby hospital’s Ethics committee supervises it.

The Ethics Committee plays an important role as it is responsible for approving a trial to initiate at a primary level. It also ensures that the trial is in line with scientific-statistical practices.

Criteria for Participating in a Human Trial

Criteria depend on what the goal of human trial. For instance, if you have or had COVID-19 infection, you are not an ideal candidate for the vaccine trial. This is because you may have developed immunity to the virus and thus won’t be able to give a clear picture of the vaccine’s efficacy.

Let’s take one more example of a human trial for a drug to treat cancer. In this case, human trials can include those who already suffer from that particular form of cancer.

All in all, researchers develop strict criteria about who can participate in human trials. Only if you meet those criteria, you will be able to participate in it.

Of note, you will be explained all the terms involved in the trials, especially the risks. Before being a part of the trial, you will have to provide informed consent. Once you agree to it, you will have to follow all instructions thoroughly, such as measures to avoid pregnancy or avoid a specific food item.

What Happens in the Trial?

If you take part in a trial, you will be either put in either of the following two groups:

  • Experimental: You will get the experimental vaccine

  • Control: You will get a placebo, which will not alter your health in any way

In either case, your medical samples will be collected on the administration of the dose. You will also be informed about your study findings.

Human Trials for Indian COVID-19 Vaccine

The Drugs Controller General of India (DCGI) has allowed human trials for two vaccines is being carried out in India.

  • Zydus Cadila: ZyCoV-D vaccine is based on radical technology and developed Zydus Cadila, which is an Ahmedabad-based pharma company. Human trials for this vaccine started in July and is estimated to have a total of 1048 participants in phase I and II. It might take up to a year to complete this trial.

  • Bharat Biotech: Covaxin is a traditional vaccine developed by Bharat Biotech along with the Indian Council of Medical Research. The SARS-CoV-2 strain was identified in NIV and offered to Bharat Biotech.

Human trials of this vaccine have also initiated in Mid-July. It is estimated to have 375 and 750 participants in phases I and II, respectively. This vaccine might take around 15 months to complete the trial. AIIMS-Delhi is one of the other 12 sites where phase I and II trials are being conducted.

How Long Will It Take for The COVID-19 Vaccine to Roll Out?

While the coronavirus vaccine will be rolled out faster than a typical vaccine, researchers believe that it might take at least 12 – 18 months.

Disclaimer: Indian Health Bureau does not claim any responsibility for the information contained in this article. The information may not hold good for everyone. The post is for general awareness only and should not be construed as a substitute for qualified medical opinion. Please consult your doctor to know what is good for you.



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