摘要
疫苗储存运输要遵循冷链运输(cold chain,CC)的要求,这很大程度上限制了疫苗的接种和普及,尤其是在那些贫困偏远地区。为扩大疫苗可及性,世界卫生组织(World Health Organization,WHO)于2012年首次提出了受控温度链(controlled temperature chain,CTC)法规,即在政府部门和WHO的监管下,在有充分热稳定性数据支持的前提下,若申报CTC的疫苗在不低于40℃下存放至少3 d后仍能保证效力,则该疫苗在免疫供应链后期无需冷链运输。CTC法规已成功应用在包括MenAfriVac在内的4个商品化疫苗上。本文介绍了CTC法规的内容和应用情况,通过科学监管提高疫苗可及性,减少不必要的浪费。
The need to keep vaccine in a traditional cold chain （CC） is a constraining factor for many immunization campaigns,particularly in the resource-limited countries.Increased flexibility with an approach newly introduced in 2012 was implemented with meningitis a vaccine,MenAfriVac,across sub-Saharan Africa,after thorough review of the scientific data by regulatory authorities and World Health Organization （WHO）.This approach was termed ＂controlled temperature chain＂ （CTC） by allowing the vaccines to be exposed at temperatures of up to 40 ℃ for a minimum of three days prior to the administration of the vaccine.There are four vaccines were licensed for CTC,including MenAfriVac.This article introduces the details and the applications of CTC.More efforts are underway to fully realize the potentials of the CTC strategy for increased vaccine accessibility and reduced wastage.
作者
陈思伊
张彩
黄小芬
王鑫
赵勤俭
CHEN Si-yi ZHANG Cai HUANG Xiao-fen WANG Xin ZHAO Qin-jian(National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, Xiamen 361102, China School of Life Science, Xiamen University, Xiamen 361102, China School of Public Health, Xiamen University, Xiamen 361102, China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2017年第20期2369-2375,共7页
Chinese Journal of New Drugs
关键词
疫苗
科学监管
受控温度链
可及性
接种推广
vaccine
regulatory sciences
controlled temperature chain
accessibility
immunization campaign
