Enhanced vaccine accessibility through innovative regulatory sciences
- 生命科学－已发表论文 
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 termedcontrolled 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.