Abstract
Artificial intelligence (AI) has potential to surpass human capabilities to reshape vaccine design. However, its integration raises legal, ethical, and intellectual property challenges. Transparency in AI-driven immunological products is crucial for regulatory approval and public trust. This article examines the "black-box" effect, liability concerns, and the need for human-interpretable reports summarizing the data processing and algorithm execution behind the AI-made decisions. This will ensure safety, accessibility, and regulatory compliance in the development of AI-generated vaccines and other immune therapeutics against infectious diseases.