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

Abstract

Diphtheria-tetanus-pertussis-containing 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 vaccines, using descriptive and comparative analyses to highlight pivotal registration issues for DTPCVs. Specifically, it sheds light on the regulatory approaches of the Food and Drug Administration (FDA), European Medicines Agency (EMA), National Medical Products Administration (NMPA), and other Asian regulators through a case study of hepatitis B-containing DTPCVs. Drawing on these findings, this study advocates the initiation of regulatory convergence efforts, establishment of practical regulatory strategies, and swift approval and wider adoption of high-valent DTPCVs.

Fig. 1

Regulatory and licensing milestones of diphtheria-tetanus-pertussis-containing vaccines (DTPCV). *Representing the major marketed hexavalent vaccines worldwide.Hexaxim and HexaSIIL were included in the WHO list of prequalified vaccines in 2014 and 2023 respectively. Besides, Pantaxim was licensed in China in 2011 and Vaxelis was licensed in U.S. in 2018. “New Meilianjitai” (DTaP/Hib) was from Beijing Minhai Biotechnology (https://www.biominhai.com/product/11.html).

Fig. 2

The immunization schedules of HepB-containing vaccines in Korea.