Pull out your scientific lab notebook:. it’s time to understand how vaccines are developed. If you are a student thinking about the eight years of college education that it will take to become a pharmacist, or are just interested in what takes place over the 10 to 15 years it takes to develop a vaccine, keep reading for all the notes you need to fill up your scientific lab notebook.
The World Before Vaccines
Today, students all over the United States or filling up scientific lab notebook after notebook with information to help them develop the next important scientific breakthrough, and we can easily take vaccines for granted. It was not always like this. Before vaccines became a worldwide reality, everyday people lives constantly with the fear of severe illness and death or disability from diseases that today have been almost entirely eradicated. In the 20th century alone, approximately 300,000,000 people died from smallpox before a vaccine was invented. There is no doubt vaccines have changed our world and improved our health.
Early American Vaccines
At the end of the 1800s, there were several important vaccines that had been developed and were in regular use. These included vaccines against rabies, smallpox, typhoid, and cholera. However, at the time, there was no regulation of vaccinations. In 1902, Congress passed an act to regulate the sale the vaccines, and this was the first modern federal legislation that controlled how vaccines are produced, sold, and stored. The legislation was spurred on by two separate contamination events that had taken place involving the smallpox vaccine and diphtheria antigen. This eventually lead to the creation of the National Institutes of Health.
In the United States, there are several steps that must be followed to develop, test and then market of vaccine. In the first step, basic laboratory research is done. Both scientists and their students break out their scientific lab notebook and research materials and find out everything they can about every natural or synthetic antigen that might help treat a disease. Once a likely candidate is found, pre-clinical studies begin. These studies use living tissues and sometimes animal testing to see if the candidate vaccine is safe and effective. Many vaccines never get beyond this stage because they do not work as hoped or are too dangerous.
If a vaccine candidate does make it past the preclinical stage, a sponsor well then make an Investigational New Drug application to the USFDA. Phase 1 vaccine trials will begin, provided the FDA approves the application. In Phase 1, testing only a small group of adults take the vaccine, even if the vaccine is ultimately intended to help children. The goal of this phase is simply to determine whether the vaccine is safe and whether it provokes the immune response hoped for in human beings. If a vaccine passes this stage of testing, it will move on to Phase 2 trials.
In Phase 2 vaccine trials, a much larger group of people will participate. Many of these will be people who belong to groups with a known risk of contracting the disease. Phase 2 trials must be carefully controlled and randomized and will include a placebo group. The goal of Phase 2 testing is to further evaluate the safety and efficacy of the treatment and develop proposed doses and schedules, as well as determine the best method of delivering the vaccine. The final stage is Phase 3. Vaccines that make it through the first two phases will move on to the stage. These tests are randomized and double-blind and will test the vaccine on a very large group of people against the placebo. Assuming all goes well at this sage, the developer will apply for approval from the FDA.
Vaccine Approval and Licensure
The FDA will investigate and render a verdict. If they approve, the vaccine will be released. Initially, it will be specially monitored by the FDA and will continue with Phase IV trials, just to make sure no issues come up.
Making a vaccine is a time-consuming and expensive project, but it is well worth it for the lives it saves.