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孕妇寨卡病毒疫苗的临床试验与管理:从孕期和哺乳期排除埃博拉疫苗接种中(本应)吸取的教训。

Clinical Trials and Administration of Zika Virus Vaccine in Pregnant Women: Lessons (that Should Have Been) Learned from Excluding Immunization with the Ebola Vaccine during Pregnancy and Lactation.

作者信息

Schwartz David A

机构信息

Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.

出版信息

Vaccines (Basel). 2018 Dec 4;6(4):81. doi: 10.3390/vaccines6040081.

DOI:10.3390/vaccines6040081
PMID:30518082
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6313913/
Abstract

As evidenced from recent epidemics, both Ebola and Zika virus infection are potentially catastrophic when occurring in pregnant women. Ebola virus causes extremely high rates of mortality in both mothers and infants; Zika virus is a TORCH infection that produces a congenital malformation syndrome and pediatric neurodevelopmental abnormalities. Production of efficacious vaccines has been a public health priority for both infections. Unfortunately, during the clinical trials and subsequent deployment of a vaccine for the Ebola virus, pregnant and lactating women were, and continue to be, excluded from receiving the life-saving vaccine. The most serious consequence of Zika virus infection, congenital Zika syndrome, results from fetal infection during pregnancy. Thus, pregnant women have a major stake in the ongoing development of a vaccine for Zika virus. The exclusion of pregnant women from the development, clinical trials and administration of a potential Zika vaccine unfairly deprives them and their infants of the protection they need against this potentially catastrophic intrauterine infection. When creating policy about these issues, it is important to critically evaluate vaccine safety in pregnancy in the context of the substantial risk of infection for the pregnant woman and her fetus in the absence of immunization.

摘要

从最近的疫情可见,埃博拉病毒和寨卡病毒感染一旦发生在孕妇身上都可能带来灾难性后果。埃博拉病毒在母亲和婴儿中都导致极高的死亡率;寨卡病毒是一种可导致先天性畸形综合征和儿童神经发育异常的TORCH感染病原体。研发有效的疫苗一直是针对这两种感染的公共卫生优先事项。不幸的是,在埃博拉病毒疫苗的临床试验及后续推广过程中,孕妇和哺乳期妇女过去被、现在仍然被排除在接种这种救命疫苗的范围之外。寨卡病毒感染最严重的后果,即先天性寨卡综合征,是由孕期胎儿感染引起的。因此,孕妇在寨卡病毒疫苗的持续研发中有着重大利害关系。将孕妇排除在潜在寨卡疫苗的研发、临床试验和接种范围之外,不公平地剥夺了她们及其婴儿获得针对这种潜在灾难性宫内感染所需保护的权利。在制定有关这些问题的政策时,在孕妇及其胎儿在未接种疫苗时面临重大感染风险的背景下,审慎评估孕期疫苗安全性非常重要。

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