Topic Nine
How are vaccines proven safe and what are the research methods used?
Vaccines undergo rigorous development and testing to ensure they are safe and effective for public use. This topic explores the different stages of vaccine development, from preclinical trials to regulatory approval and ongoing monitoring. You’ll learn about the role of scientific evidence, clinical trials, and surveillance in maintaining vaccine safety.
LEARNING INTENTIONS
- Understand the purpose and phases of clinical trials.
- Explore the regulatory approval process for vaccines.
- Recognise the importance of post-marketing surveillance in ensuring vaccine safety.
SUCCESS CRITERIA
- Explain the purpose of clinical trials and their different phases.
- Describe how vaccines are assessed and approved by regulatory authorities.
- Identify how vaccines are monitored after they are introduced.
Vaccine Trials
Vaccines must pass preclinical trials and three phases of clinical trials before they are licensed for use. Once approved, regulatory authorities continue to monitor vaccines for safety and effectiveness to ensure public health is protected.
In the following video, Prof. Robert Booy walks us through the four key stages of vaccine development: pre-clinical trials, clinical development, regulatory review, and post-marketing surveillance. Using the example of the HPV vaccine, Prof. Booy highlights how these stages ensure vaccines are safe, effective, and ready for widespread use, with continuous monitoring even after they are introduced to the public.