In the last two centuries, vaccines have been developed to prevent the spread of diseases such as smallpox, polio and measles. As vaccine research has evolved, researchers and regulators have established a rigorous process to ensure that vaccines not only work, but also are safe to use.
Clinical trials are a crucial part of that development process. Testing vaccines on diverse populations gives researchers access to a wealth of data to better understand how patients will respond to a vaccine, as well as the potential side effects of that treatment.
By the time a vaccine enters clinical trials, it has already undergone exploratory and preclinical studies in laboratories. In these, studies antigens—substances that activate the body’s immune response—are identified and tested for their potential to protect from disease-causing pathogens such as viruses and bacteria in controlled settings. These trials often are performed on animals such as mice or monkeys.
Once an antigen is determined to cause the needed immune response in the laboratory, three phases of clinical trials on humans begin.
In Phase I, researchers will administer the vaccine to small groups of adult test subjects. This phase is designed to answer two key questions: what kind of immune response do participants have to the vaccine, and are there any safety concerns?
Phase II expands the test subject pool to a few hundred individuals. In this phase, researchers are better able to determine the vaccine’s overall safety and efficacy, and begin to determine dosage and immunization schedules for a wider population. With this expanded subject pool, a wider array of side effects may begin to appear, alerting researchers to potential safety issues.
Phase III is the final clinical phase before a vaccine is delivered to the general public. In Phase III trials, the test pool expands significantly to include many thousands of people, and the primary goal is to test safety and efficacy among large groups of people.
After Phase III trials the vaccine is then submitted for approval by the U.S. Food and Drug Administration for use with the general population. Many vaccines will then move into an additional research phase, which assesses the ongoing safety and effectiveness of the vaccine over time.
The Benefits Of Diversity
All people who will receive a vaccine should be represented by participants in clinical trials. However, representation hasn’t always been a focus in these trials. In fact, Black/African American and Hispanic/Latino patients have often been underrepresented in the clinical trial process.
Including a more diverse pool of participants in each stage of the clinical trial process can give researchers more insight into how a treatment will affect a broader range of patient groups. In turn, that information can help steer the development process to create vaccines that work more effectively and safely for more people.
The goal of any vaccine is to minimize or even eradicate the spread of dangerous diseases. By creating treatments that are designed to work for everyone, researchers are helping to make vaccines even more effective and safe. In certain instances where conditions from a disease could severely affect a large population of people, the FDA may issue an Emergency Use Authorization (EUA). An EUA helps to get a treatment or investigational vaccine more quickly to the people who need it.
Learn more at wedovaccines.com
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