Presently, vaccines development and production has gained more importance due to their influence on topics such as the society's health system and economy, as well as the bio-security issues and the defense affairs. Moreover, the potential innovation capabilities in vaccine production are assumed as engines of biotechnology development which is among the emerging technologies that can support the technological development of a country. This review is based on analyses of scientific articles, literature, textbooks and reports by the international organization, as well as online databases with the subject of innovation in vaccine production, in order to identify current challenges in vaccine development and production. Not long ago, the most important challenges in this field were assumed as technical or budgetary issues. However nowadays, due to a global paradigm-shift in vaccine production which has changed from innovation aimed solely at the registration of new products toward promoting public health, other challenges in competition and commercialization have stepped in. The identified new challenges and bottlenecks could be used to form practical approaches in policy-making toward vaccine development and production. Furthermore, overcoming these challenges requires identifying the bottlenecks and proper orientation with the current world circumstances to draft a functional policy that could fulfill the national health system objectives. Here, following explaining these global challenges and approaches, the situation of vaccine industry in Iran will be briefly discussed.

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