The development and approval of vaccines is a highly complex process that involves multiple complex steps. Creating an effective immunization is the result of diligent clinical trial research and careful evaluation from regulatory bodies ensuring safety, efficacy, and quality before any new vaccine can be approved for use. At Miami Clinical Research, our medical researchers are dedicated to providing unparalleled clinical trials research that facilitates the creation of life-saving vaccines.
When a new vaccine is being developed, it’s first evaluated in the laboratory to make sure it inhibits the production of disease-causing viruses and bacteria. Afterward, scientists study the safety and effectiveness of the vaccine in animals before they can advance to higher level research. From there, scientists progress to multiple phases of clinical trial research on human volunteers in order to test the new vaccine.
In the first phase of clinical research, vaccine developers study the safety of the vaccine within small groups of people to determine the optimal dose and compound of the vaccine. Scientists then progress to phase two clinical trials, during which larger groups of people are exposed to the vaccine to evaluate its safety and ability to induce an immune response. Finally, phase three clinical trials utilize huge groups of volunteers to observe the results of the new vaccine over an extended period of time.
Following success in the clinical trial stages, vaccine developers must gather the facts and present them to regulatory bodies such as the Centers for Disease Control and Prevention (CDC). U.S. laws require that the information is thoroughly reviewed towards this end before safety and effectiveness are validated and the product can be made widely available in the market. This step not only involves the evaluation of the vaccine itself, but obtaining feedback on multiple other aspects such as environmental factors, economic evaluation, social cultural acceptability, and product labeling.
Once the regulatory body is happy with the final product and the risks of using the vaccine are duly balanced against the benefits, the vaccine can then be approved for public use. Upon successful vaccine approval, manufacturers are licensed and heavily inspected by the FDA to make sure the standard for producing the vaccine is met. Simultaneously, the conversations held with the public surrounding the new vaccine start to spread awareness and product availability.
Overall, Miami Clinical Research is committed to providing doctors, scientists, and drug developers with the highest quality of clinical trial research that ensures the successful development of life-saving vaccines. Our medical research teams are dedicated to facilitating the development of safe and efficacious vaccines that are eventually approved by regulatory bodies, allowing for care and protection of the public’s health.
At Miami Clinical Research, we are dedicated to bringing the latest pharmaceutical studies to life with the help of our state-of-the-art equipment and technology. Our cutting-edge facilities and reliable services provide Sponsors with the confidence and assurance that their research studies are being conducted at a “Top 10 Clinical Research Provider.” To learn more, call 305-433-6496 or email us at info@miamiclinicalresearch.com.
