A vaccine may be a biological preparation that gives immunity to a specific communicable disease. A vaccine contains a particle that resembles a disease causing micro-organism. It is often made from weakened or killed forms of microbe or one of its surface proteins. The agent stimulates the body’s system to acknowledge and destroy any of the micro-organisms related to that agent. Vaccines can be prophylactic which means that prevent the effects of a future infection by a natural pathogen. Or it can be therapeutic, which fights a disease that has already occurred, such as cancer. The administration of vaccine is called vaccination. Widespread immunity due to vaccination is responsible for the eradication of smallpox, polio, measles, and tetanus from the world. The effectiveness of vaccination is known to the entire world. Vaccines that have proven effective include the influenza vaccine, the HPV vaccine, and therefore the chicken pox vaccine. The World Health Organization reports that, licensed vaccines are currently available for twenty-five preventable infections. Limitations to their effectiveness, nevertheless, exist. Sometimes, protection fails because of vaccine related failure such as, failures in vaccine attenuation, vaccine regiments or host related failure due to lack of response from host’s immune system.
Vaccine development is a complex process, which demands both public and private involvement. There are different stages in vaccine development.
The first stage is Exploratory Stage. This includes basic laboratory research. The identification of natural or synthetic antigens that might help in preventing or treating a disease also take place during this stage. The second stage is the Pre-Clinical Stage in which animal testing is conducted to assess the safety of the vaccine and its immunogenicity, or to assess its ability to provoke an immune response. Many vaccines do not go beyond this stage because they fail to give the desired immune response. The next is IND Application. In this stage the sponsor submits an application describing the manufacturing and testing process, summarizing the laboratory reports, and also describes the proposed study in detail. A review board, representing the institution where the clinical trials will be conducted, should approve the application within 30 days of its submission. If the application is approved, the vaccine can be now subjected to three phases of testing.
The next stage is the vaccine trials conducted in three phases. The phase 1 vaccine trial, assess the vaccine in humans involving a small group of adults. If the vaccine is for children, it is first tested in adults and then gradually decreases the age until the target is reached. The main aim
of phase 1 vaccine trial is to assess the safety of the vaccine and to determine the type and extent of immune reaction the vaccine provides.
A successful phase 1 trial progresses to phase 2 testing. In phase 2 study of vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery takes place. Promising phase 2 trial move on to larger trials, including thousands, and tens of thousands of people. The main aim is to assess vaccine safety in large group of people, and to examine side effects of the vaccine. After the successful completion of phase 3 trial, the developer applies for the license for starting the production of vaccine. The reviewing committee monitors vaccine development after the approval. This involves phase 4 trial, vaccine adverse event reporting system, and vaccine safety datalink. Phase 4 vaccine trial includes the testing of the vaccine by the manufacturer after its release, to assess the vaccine safety, efficacy, and other potential uses.
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