Yao Kai-Hu, Jia Ju
National Center for Children's Health/Beijing Children's Hospital, Capital Medical University/Beijing Pediatric Research Institute/National Key Discipline of Pediatrics (Capital Medical University)/National Clinical Research Center for Respiratory Diseases/Key Laboratory of Major Diseases in Children, Ministry of Education/Beijing Key Laboratory of Pediatric Respiratory Infectious Diseases, Beijing 100045, China.
Zhongguo Dang Dai Er Ke Za Zhi. 2018 Jan;20(1):1-4. doi: 10.7499/j.issn.1008-8830.2018.01.001.
On November 3, 2017, the China Food and Drug Administration reported that the potency indexes of two batches of diphtheria-pertussis-tetanus vaccines produced by two companies did not reach the requirements. Insufficient potency could affect the protection effect of these vaccines immunization. Currently, pertussis cases have already showed an increasing trend in China and could last for several years. Such an increase could be linked to these adverse events of vaccine with insufficient potency, which could become an evidence to challenge or deny the effectiveness of vaccination, and brings a persistent inhibition of the public's acceptance for vaccination. The wider global context of pertussis resurgence, previous underestimate on the domestic pertussis, the promotion of detection methods, the change of knowledge about pertussis, the confirmation of pertussis in elder children and adults, the antigenicity variation of pertussis strains could lead to a significant increase of pertussis cases. Health researchers and clinical workers should raise awareness about these factors, and assess rationally the impact of vaccine titer deficiency on pertussis epidemiology for maintaining and promoting public confidence in vaccination.
2017年11月3日,中国食品药品监督管理总局通报,两家企业生产的两批次百白破疫苗效价指标未达到标准要求。效价不足可能影响疫苗接种后的保护效果。当前,我国百日咳病例已呈现上升趋势,且可能持续数年。这种上升可能与这些效价不足疫苗的不良事件有关,这可能成为质疑或否定疫苗接种效果的依据,并持续抑制公众对接种疫苗的接受度。全球范围内百日咳疫情的再度出现、以往对国内百日咳情况的低估、检测方法的改进、对百日咳认识的变化、大龄儿童及成人百日咳确诊病例的增加、百日咳菌株抗原性变异等因素,都可能导致百日咳病例显著增加。卫生研究人员和临床工作者应提高对这些因素的认识,并合理评估疫苗效价不足对百日咳流行病学的影响,以维持和提升公众对疫苗接种的信心。