The transition phase of bridging preclinical to clinical vaccine development determines whether promising lab discoveries translate into viable human candidates. It requires extensive immunogenicity and toxicity testing in animal models, followed by the careful design of early-phase human trials. Regulatory compliance, scalability of manufacturing, and formulation adjustments must be addressed before clinical translation. Bridging preclinical to clinical vaccine development also involves selecting relevant biomarkers, determining appropriate dosing regimens, and mitigating risks. With the emergence of new platforms such as viral vectors and nucleic acid vaccines, this bridging phase has gained even more significance. Streamlined coordination between research institutions, industry, and regulatory authorities is key to accelerating the journey from bench to bedside.
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