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
- Reading time: 4 min.
He, Xiangchuan; Pu, Yiwen; Li, Zeyu; Huan, Shitong; Yang, Yue.
Abstract
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 to fast-track the approval and uptake of critical DTPCVs to address public health needs. This study examined the global regulatory status of combination...
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