Research and Development (R&D) Phase: During this phase, antigens are developed that can be used in vaccine development against a specific microbe. Cell culture, microbiological cultures, recombinant DNA (rcDNA) technology, and computer modeling are the methods used for the development of a new vaccine.
Preclinical Studies (Phase 0): This phase involves the production of antigens and strains to be used in vaccines in accordance with the international standards of vaccine formulation development, in vitro experiments, and in vivo animal experiments. The immune response to the agent (antigen) is investigated by administering the vaccine candidate to experimental animals or humans in micro-doses.
Phases of Clinical Research: If a vaccine induces effective cellular and humoral immunity, have proven reliable, safe and have been developed as a prototype, the Phase 1, Phase 2, and Phase 3 clinical studies of the vaccines are completed. The licensing phase of these vaccines showing high quality, efficacy, and safety can be initiated.