Global Disease Epidemiology and Control, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
Centre of Vaccinology, University of Geneva, Geneva, GE, Switzerland.
BMJ Glob Health. 2021 May;6(Suppl 2). doi: 10.1136/bmjgh-2020-003814.
Vaccine licensure requires a very high safety standard and vaccines routinely used are very safe. Vaccine safety monitoring prelicensure and postlicensure enables continual assessment to ensure the benefits outweigh the risks and, when safety problems arise, they are quickly identified, characterised and further problems prevented when possible. We review five vaccine safety case studies: (1) dengue vaccine and enhanced dengue disease, (2) pandemic influenza vaccine and narcolepsy, (3) rotavirus vaccine and intussusception, (4) human papillomavirus vaccine and postural orthostatic tachycardia syndrome and complex regional pain syndrome, and (5) RTS,S/adjuvant system 01 malaria vaccine and meningitis, cerebral malaria, female mortality and rebound severe malaria. These case studies were selected because they are recent and varied in the vaccine safety challenges they elucidate. Bringing these case studies together, we develop lessons learned that can be useful for addressing some of the potential safety issues that will inevitably arise with new vaccines.
疫苗上市许可需要非常高的安全性标准，而常规使用的疫苗通常非常安全。疫苗上市前和上市后的安全性监测可进行持续评估，以确保收益大于风险，并且在出现安全性问题时，能够快速识别、描述并尽可能防止进一步的问题。我们回顾了五个疫苗安全性案例研究：（1）登革热疫苗与登革热疾病加重，（2）大流行性流感疫苗与发作性睡病，（3）轮状病毒疫苗与肠套叠，（4）人乳头瘤病毒疫苗与体位性心动过速综合征和复杂性区域疼痛综合征，以及（5）RTS,S/佐剂系统 01 疟疾疫苗与脑膜炎、脑型疟疾、女性死亡率和疟疾反弹。选择这些案例研究是因为它们是最近的，并且阐明了疫苗安全性挑战的多样性。将这些案例研究放在一起，我们总结了经验教训，这些经验教训对于解决新疫苗不可避免出现的一些潜在安全性问题可能会有所帮助。
