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The global regulatory landscape for combined vaccines: A comparative case study of registration strategies for diphtheria-tetanus-pertussis-containing vaccines.

Published on 06/05/2025 |  Original article (Full-text)  | He, Xiangchuan et al. | Vaccine 2025; 54(In progress): 127017 4 min.

Diphtheria-tetanus-pertussis-c ontaining vaccines (DTPCVs) represent the forefront of combination vaccine development globally. However, the licensing of high-valent DTPCVs varies worldwide owing to diverse regulatory requirements. Some national regulatory authorities (NRAs) have adopted flexible strategies...