Lesson 3 Vaccine development
Research and discovery stage
- Research on the virus and development of possible vaccine ideas
Pre-clinical
- More laboratory research
- Testing on animals to see if the vaccine works and if it is safe
Clinical development-phase 1
- Testing on humans begins
- 20-100 healthy volunteers to check for the safety and appropriate dosage
Clinical development-phase 2
- More people are included in the study with various health statuses, difference in demographics in randomised studies.
Clinical development-phase 3
- The vaccine is given to more people to check effectiveness and safety
- Participants receive the actual vaccine or a placebo(usually salt water) to check the actual effectiveness
Special considerations
- In cases of a pandemic these processes speed up
Approval
- Permission to distribute the vaccine
Phase 4
- Monitoring of safety and effectiveness after distribution
- Monitor the quality of the vaccine
Table by RESET
