The research and development process (R&D) of a new vaccine is made up of
several stages, and is therefore a time-consuming, high-investment process
associated with high risks, particularly when dealing with neglected diseases.
First step: basic research where new vaccine proposals are identified. Second step: pre-clinical tests (in vitro and/or in vivo) to demonstrate vaccine safety and immunogenic potential. Third step: clinical trials, the longest and most expensive step of R&D. Clinical trials of a new vaccine are classified in Phase I, Phase II, Phase III and Phase IV studies.
Phases of clinical study/trial
Phase I: the first study in human beings. Aims to demonstrate vaccine safety.
Phase II: aims to establish its immunogenicity.
Phase III: the last phase before obtaining sanitary registration. Aims to demonstrate its efficacy. Only after completing the phase III study and obtaining sanitary registration will the new vaccine be made available to the population. Phase IV: Vaccine made available to the population.
The Clinical Trial and Pharmacovigilance Division of Instituto Butantan (IB) coordinates all clinical trials, from Phase I to Phase IV, of the immunobiologicals produced by the Institute, including vaccines. As a result, this Division ensures the internalization of the knowledge acquired through these studies and contributes to the integration of all stages of the R&D process. It should also be noted that this Division also carries out pharmacovigilance activities for all antitoxins, antivenoms and vaccines produced by IB, that is, it carries out continuous safety monitoring of these products when they are already available and in use by the population.