Technical Evolution and Research Advances in Quality of Pertussis Vaccines

Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, characterized by high transmissibility and posing a serious threat to the health of infants and young children. Despite widespread vaccination, the global resurgence of pertussis in recent years has highlighted the limitations of current vaccines. This review outlines the development of pertussis vaccines from whole-cell pertussis vaccines to acellular pertussis vaccines, focuses on current core strategies in vaccine research, elaborates on antigen selection and formulation, describes the optimization path for purification processes, and critically discusses detoxification along with the key technical points for establishing a quality research system under the new situation. Furthermore, drawing on global research experience, this review discusses the “consistency evaluation”-centered quality system covering potency assessment, impurity control, structural characterization, and lot-to-lot consistency, aiming to support pharmaceutical research, process optimization, and quality improvement of pertussis vaccines in China.