Vaccine Production
Vaccine scientists work under the premise that it is always better to prevent a disease than to treat it. As a result, research is constantly being conducted to identify microorganisms, viruses or toxins that merit preventative action, and to develop corresponding vaccines.
Candidate vaccines are developed and rigorously tested throughout various stages of their development starting with laboratory tests which are followed by a three-stage clinical trial program. The Food and Drug Administration (FDA) ultimately evaluates vaccines and determines their date of release for medical use based on three main variables:
- Safety
- Effectiveness
- Stability during shelf life
How a Vaccine is Developed
- Scientists study a disease and isolate a vaccine.
- Computer models are used to predict how the vaccine will work in the human body.
- Pre-clinical studies are conducted - the medicine is tested on animals.
- Phase I Trials: Human Testing: The vaccine is tested on a small group of human volunteers to check for safety and possible side-effects
- Phase II Trials: Vaccine trials can take months or years, and involve testing the vaccine on larger groups of people to study safety, how the immune system responds to the vaccine and to refine dosages.
- Phase III Trials: These trials involve thousands of people and may run for several years to ensure the vaccine is safe and effective.
- The company that makes the vaccine applies to the FDA for a license.
- The FDA reviews all of the testing results and reports and inspects the facility where the vaccine will be manufactured.
- A license may be issued by the FDA for the vaccine, as well as the manufacturing facility where it will be produced.
- After being licensed by the FDA, the vaccine continues to be monitored for safety as it is being used in the general population.