 This review aims to present unique considerations for manufacturing and regulating new vaccines in Muslim-populated countries such as Malaysia, highlighting vaccine production, ingredients of concern, the current mechanism for ruling and recommendations on new vaccines, decision-making steps, issues and challenges, commercial viability, and promoting self-reliance through Halal vaccine production. This article was authored by Yvonne S. K. Koo, A. A. B. Ghani, A. A. Navamikandan and others.