Developing a new vaccine is typically a long process that takes many years. The basic stages of development include:
1. Exploratory:
- Basic lab research to identify natural or synthetic antigens that could be used
- Can take years
2. Pre-clinical:
- Tissue culture, cell culture, and animals are used for testing
- Takes 1-2 years; many possible candidates fail this stage
- If successful thus far, an Investigational Drug Application (IDA) is made
3. Clinical development:
- Phase I – small groups of people receive the vaccine to assess safety
- Phase II – more people receive the vaccine, targeting certain ages, groups, etc.
- Phase III – the vaccine is given to thousands and tested for efficacy and safety
4. Regulatory review and approval
5. Manufacturing
6. Quality control
