Vaccine studies
- The aim of vaccine studies is to reach new vaccines that are as efficient and safe as possible, to prevent serious illnesses.
- The development of a new vaccine is demanding and usually takes over 10 years. Only a small portion of the preparations proceed into clinical research i.e. studies that target humans, and still fewer become finished products..
- There are strict quality and safety criteria for vaccine studies, and the research complies with the laws, statutes and the EU directive concerning pharmaceutical research. In Finland the studies are controlled by the Finnish Medicines Agency Fimea. In addition, studies that target humans require the approval of a local ethical committee or the National Committee on Medical Research Ethics (TUKIJA).
- Before initiating the study, information is gathered about the mechanism of origin, incidence and dangerousness of the disease in question. The actual vaccine study consists of five phases. The first phase (phase 0), that precedes the clinical studies takes place in the laboratory, where the new vaccine is examined chemically, possibly in cell cultures and in test animals.
- The three following phases (phases 1-3) are carried out in volunteers. In the first phase only some dozens of persons participate, but when the vaccine has proceeded into extensive efficacy studies (phase 3), there can be tens of thousands of participants. The vaccine study continues even after the approval of the marketing authorization with the monitoring of the efficacy and the adverse events of the vaccine (phase 4).
- In Finland vaccine research is carried out by THL, FVR - Finnish Vaccine Research, Meilahti Vaccine Research Center, Clinical Research Services Turku, universities, university central hospitals, medical centers and pharmaceutical companies.
Further reading
- THL, research and development
- FVR - Finnish Vaccine Research
- Meilahti Vaccine Research Center (MeVac)
- Clinical Research Services Turku