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THE PROCESS OF DEVELOPING SAFE VACCINE

21 November 2020

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Science General

We've seen the world turn upside down since the Covid-19 pandemic wrecked the world. Scientists worldwide have since been on their toes to develop a vaccine for this curse. Developing a safe vaccine is not a simple task. It requires a lot of time as well as effort. In the majority of cases, a vaccine takes around 10 to 15 years to develop. 

We thought this would be an ideal time to tell our readers how a vaccine is made in general. This article won't include steps to produce a Covid-19 vaccine but will touch on the basic steps as to how a standard vaccine is created. It will help you understand the long and tedious process involved in creating a successful vaccine for use.    


FIRST STEP:

RESEARCH STAGE

Primary research is an essential step in developing a safe vaccine. All scientific advances rely on primary research and its findings to move ahead. 

The first step in developing a vaccine is an exploratory step. This step involves extensive research, which may last 3 to 4 years. This step involves generating an antigen, which can be synthetic or natural. Antigens are those substances that are successful in bringing out a reaction in our immune systems. These substances also prove and show evidence of protecting our immune systems. Identifying an antigen is not as easy as it sounds since it requires intensive research and can take several years. 

During this type of research, many such substances are found that are antigens and bring out a positive reaction in our immune systems. At this point, the one that gets the most positive response from the immune system is chosen and worked upon. 


SECOND STEP:

PRE-CLINICAL TRIALS

In the pre-clinical trial, the entire cell system is studied. Along with that, the vaccine is tested on animals to conclude how safe the vaccine is to be used on humans. Apart from safety, animal testing also shows how much of an effect the antigen has on the immune system. Animals that are commonly used for such testing are either monkeys or mice. This pre-clinical trial gives an idea to the researchers of what kind of reaction the substance or the vaccine can have on human beings. This will also help them conclude how much the first dose would be and how to use the vaccine safely. 

This stage is considered the hardest, and most of the vaccines end at the very second stage of their development process. This is because the substance does not give the researchers the kind of reaction they were predicting or hoping for it to have on the immune system. However, it is also possible that the researchers find the candidate vaccine during animal testing, which can help them make the vaccine stronger and much more effective. Once the candidate vaccine is adapted, researchers might also do some studies with animals that are challenging in nature. This means that they will inject the pathogen into the animals being tested and then vaccinate them. 


THIRD STEP:

CLINICAL TESTING AND EVALUATION

For a vaccine to work and be registered, it has to be safe, effective, as well as pure. After this, an application is submitted for the new drug to be investigated. This is usually done by a private company or anyone who wants to sponsor the vaccine. During this step, it is the sponsor's responsibility to describe the entire process of developing the vaccine in great detail. The sponsor has to share how the vaccine is manufactured and what kind of testing it went through. They should then explain the laboratory results and reports and describe the whole study in an extensive manner.

A review board, mostly on behalf of an entire institution, must accept the whole protocol for clinical trials. The trials are conducted at the institute itself. Once this is done, the researchers will get a response within 30 days, which could be an acceptance or rejection. Once the vaccine registration and clinical testing application are approved, then comes the part where the vaccine is tested in three different stages, each stage different from the other. 


FOURTH STEP:

PHASE ONE OF THE TRIAL 

This is the first and foremost phase of testing, where the vaccine is tested on human beings. Only a small group of human beings are involved in this phase, going no more than 80 people. The reason for conducting this trial and the phase one vaccine trials is to find out how safe the vaccine is for human beings, what kind of effect it has on the immune system, and how long it takes to show the results. 

In this testing, researchers might inject them with pathogens and then conduct the vaccine trial because only a few people are tested. If the vaccine is made for children, it is tested on adults initially, gradually going down towards children to test on. Furthermore, the participants taking part in this vaccine trial are already aware of everything since this phase is not a blinded trial phase. 

PHASE TWO OF THE TRIAL

In this phase, the people being tested on are relatively a lot more than there were in the previous stages. There are almost a hundred people or more who take part in this trial of the vaccine. Most of these individuals might have the disease or are at a high risk of getting it. This phase tells the researcher about the vaccine's safety, the dose, and how to use it effectively. 

PHASE THREE OF THE TRIAL

This trial now involves more than a hundred people, as this takes place on a larger scale. This trial is conducted to gain knowledge regarding the side effects of the vaccine, as it is hard to find side effects in the previous two trials due to smaller and more controlled groups. 


FIFTH STEP:

LICENSING 

Once all three of the trials are successful, the factory is inspected, and after satisfactory results, it is labeled as a vaccine. 

Vaccine development is a long and complex process, which is based on intensive research. Vaccines have to go through many trials to get approved, and rightly so, as many people are subjected to it.