López-Gatell Hugo, Alpuche-Aranda Celia M, Santos-Preciado José I, Hernández-Ávila Mauricio
National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca, 62100, Mexico .
Division of Experimental Medicine, National Autonomous University of Mexico, Mexico City, Mexico .
Bull World Health Organ. 2016 Nov 1;94(11):850-855. doi: 10.2471/BLT.15.168765. Epub 2016 Sep 7.
As new vaccines against diseases that are prevalent in low- and middle-income countries gradually become available, national health authorities are presented with new regulatory and policy challenges. The use of CYD-TDV - a chimeric tetravalent, live-attenuated dengue vaccine - was recently approved in five countries. Although promising for public health, this vaccine has only partial and heterogeneous efficacy and may have substantial adverse effects. In trials, children who were aged 2-5 years when first given CYD-TDV were seven times more likely to be hospitalized for dengue, in the third year post-vaccination, than their counterparts in the control group. As it has not been clarified whether this adverse effect is only a function of age or is determined by dengue serostatus, doubts have been cast over the long-term safety of this vaccine in seronegative individuals of any age. Any deployment of the vaccine, which should be very cautious and only considered after a rigorous evaluation of the vaccine's risk-benefit ratio in explicit national and subnational scenarios, needs to be followed by a long-term assessment of the vaccine's effects. Furthermore, any implementation of dengue vaccines must not weaken the political and financial support of preventive measures that can simultaneously limit the impacts of dengue and several other mosquito-borne pathogens.
随着针对低收入和中等收入国家常见疾病的新型疫苗逐渐问世,各国卫生当局面临着新的监管和政策挑战。CYD-TDV(一种嵌合四价减毒活登革热疫苗)最近在五个国家获得批准。尽管该疫苗对公共卫生有一定前景,但它只有部分且异质性的疗效,并且可能有严重的不良反应。在试验中,首次接种CYD-TDV时年龄在2至5岁的儿童,在接种疫苗后的第三年因登革热住院的可能性是对照组儿童的七倍。由于尚未明确这种不良反应仅是年龄的作用还是由登革热血清状态决定,因此对于该疫苗在任何年龄的血清阴性个体中的长期安全性存在疑虑。疫苗的任何部署都应非常谨慎,并且只有在对明确的国家和次国家层面情景下疫苗的风险效益比进行严格评估之后才应予以考虑,之后还需要对疫苗效果进行长期评估。此外,登革热疫苗的任何实施都绝不能削弱对能够同时限制登革热和其他几种蚊媒病原体影响的预防措施的政治和财政支持。