Family and Community Health Area, Pan American Health Organization, Washington, DC 20037, USA.
J Infect Dis. 2011 Sep 1;204 Suppl 2:S713-7. doi: 10.1093/infdis/jir489.
Due to the significant teratogenicity of rubella virus and the use of a live-attentuated vaccine, pregnancy is a contraindication of receipt of rubella vaccine (RCV). Data collected from several countries that have observed susceptible women who had received RCV during pregnancy documented that no infant with congenital rubella syndrome (CRS) has been born, so the risk is theoretical. As part of the regional initiative to eliminate rubella and CRS in the Americas, one of the key strategies was the vaccination of women of childbearing age. The implementation of mass vaccination campaigns targeting women of childbearing age in Argentina, Brazil, Costa Rica, Ecuador, El Salvador, and Paraguay provided an opportunity to further increase the body of knowledge on the safety of rubella vaccine if an unknowingly pregnant woman is vaccinated in early pregnancy.
Using a standard protocol, women who were unknowingly pregnant or become pregnant ≤ 30 days after receiving RCV were evaluated to determine immunity status (eg, susceptible, immune, and unknown) at the time of vaccination. Susceptible pregnant women were observed to determine the outcome of the pregnancy. For pregnancies that resulted in live births, serum samples were obtained from the newborn for rubella immunoglobulin (Ig) M antibody testing. If the newborn's serum sample was IgM positive, the infant was evaluated for manifestations of CRS.
During the period 2001-2008, 48748253 women of childbearing age were vaccinated in the region of the Americas, 39542253 (81%) of whom were vaccinated in the 6 selected countries. Of these women, 30139 (0.07%) were pregnant or became pregnant ≤1 month after receiving vaccine and were followed up. On the basis of serological evaluation, 2894 (10%) women were classified as susceptible at the time of vaccination; of their pregnancies, 1980 (90%) resulted in a live birth. Sera from 70 (3.5%) of these infants were rubella IgM antibody positive, but none of the infants had features of CRS as a result of rubella vaccination. The maximum theoretical risk for CRS following rubella vaccination of susceptible pregnant women was 0.2%. Conclusions. The results of these studies from 6 select countries provides additional evidence showing an absence of risk of CRS associated with administering rubella vaccine shortly before or during pregnancy.
由于风疹病毒具有显著的致畸性，且使用的是减毒活疫苗，因此妊娠是接种风疹疫苗（RCV）的禁忌证。从一些观察到妊娠期间接受 RCV 的易感妇女的国家收集的数据表明，没有先天性风疹综合征（CRS）患儿出生，因此风险是理论上的。作为在美洲消除风疹和 CRS 的区域倡议的一部分，关键战略之一是为育龄妇女接种疫苗。在阿根廷、巴西、哥斯达黎加、厄瓜多尔、萨尔瓦多和巴拉圭开展的针对育龄妇女的大规模疫苗接种运动为进一步增加关于风疹疫苗安全性的知识提供了机会，如果在妊娠早期无意中为孕妇接种了疫苗。
使用标准方案，对在接受 RCV 时无意中怀孕或怀孕≤30 天的妇女进行评估，以确定接种疫苗时的免疫状态（例如易感、免疫和未知）。观察易感孕妇的妊娠结局。对于导致活产的妊娠，从新生儿采集血清样本进行风疹免疫球蛋白（Ig）M 抗体检测。如果新生儿血清样本 IgM 阳性，则对婴儿进行 CRS 表现评估。
在 2001-2008 年期间，在美洲区域为 48748253 名育龄妇女接种了疫苗，其中 39542253 名（81%）在 6 个选定国家接种了疫苗。在这些妇女中，有 30139 名（0.07%）在接种疫苗后 1 个月内怀孕或怀孕，对其进行了随访。根据血清学评估，接种疫苗时，2894 名（10%）妇女被归类为易感；其中 1980 名（90%）妊娠导致活产。从其中 70 名婴儿（3.5%）的血清中检测到风疹 IgM 抗体阳性，但由于风疹疫苗接种而导致 CRS 的婴儿无一例出现特征。易感孕妇在接种风疹疫苗后发生 CRS 的理论最大风险为 0.2%。结论：来自 6 个选定国家的这些研究结果提供了额外证据，表明在妊娠前或妊娠期间不久接种风疹疫苗不会导致 CRS 风险。
