Gershman Mark D, Sotir Mark J
Division of Global Migration and Quarantine, National Center for Emerging and Zoonotic Infectious Diseases, CDC.
MMWR Morb Mortal Wkly Rep. 2017 Jul 28;66(29):780. doi: 10.15585/mmwr.mm6629a4.
Sanofi Pasteur, the manufacturer of the only yellow fever vaccine (YF-VAX) licensed in the United States, has announced that their stock of YF-VAX is totally depleted as of July 24, 2017. YF-VAX for civilian use will be unavailable for ordering from Sanofi Pasteur until mid-2018, when their new manufacturing facility is expected to be completed. However, YF-VAX might be available at some clinics for several months, until remaining supplies at those sites are exhausted. In anticipation of this temporary total depletion, in 2016, Sanofi Pasteur submitted an expanded access investigational new drug application to the Food and Drug Administration to allow for importation and use of Stamaril. The Food and Drug Administration accepted Sanofi Pasteur's application in October 2016.
赛诺菲巴斯德公司是美国唯一获得许可的黄热病疫苗(YF-VAX)的制造商,该公司宣布,截至2017年7月24日,其YF-VAX库存已全部耗尽。在其新生产设施预计于2018年年中完工之前,赛诺菲巴斯德公司将无法接受民用YF-VAX的订购。不过,YF-VAX在一些诊所可能还会供应几个月,直到这些地方的剩余库存耗尽。鉴于这种暂时的全面缺货情况,赛诺菲巴斯德公司于2016年向美国食品药品监督管理局提交了一份扩大准入的研究性新药申请,以允许进口和使用“思美泰”疫苗。美国食品药品监督管理局于2016年10月接受了赛诺菲巴斯德公司的申请。