Smallpox Vaccination during Pregnancy

Engström, Lars

doi:10.1111/j.0954-6820.1966.tb05081.x

Cited by 3 publications

(5 citation statements)

References 5 publications

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“…Although some large reviews are reassuring that no increased risk exists [8,12], other reports have cited concern that smallpox vaccination may be associated with spontaneous pregnancy loss [13][14][15][16][17]. Likewise, the risks of preterm delivery, low birth weight, and other birth problems after exposure to smallpox vaccine in pregnancy have not been defined.…”

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confidence: 99%

Pregnancy, Birth, and Infant Health Outcomes from the National Smallpox Vaccine in Pregnancy Registry, 2003–2006

Ryan

Seward

2008

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When the United States implemented civilian and military smallpox vaccination programs in 2003, the National Smallpox Vaccine in Pregnancy Registry was established to better evaluate outcomes after the inadvertent vaccination of pregnant women. Women were referred to the registry by vaccine administrators, health care providers, or state health departments or through self-referral. Registry professionals actively follow up with all enrolled women and collect data on pregnancy, birth, and infant health outcomes. As of September 2006, pregnancy outcome data were available from 376 women. Most (77%) were vaccinated near the time of conception, before results of a standard pregnancy test would have been positive. To date, outcome evaluations have not revealed higher-than-expected rates of pregnancy loss (11.9%), preterm birth (10.7%), or birth defects (2.8%), compared with those in healthy referent populations. No cases of fetal vaccinia have been identified. The Smallpox Vaccine in Pregnancy Registry continues to actively enroll women and follow infant and early-childhood health outcomes.

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Pregnancy, Birth, and Infant Health Outcomes from the National Smallpox Vaccine in Pregnancy Registry, 2003–2006

Ryan

Seward

2008

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“…6,8,11,12,20–26,28–31 Figure 3 shows the effect of smallpox vaccination on congenital defects in studies with a comparison group including a subanalysis of first-trimester exposure. Overall, smallpox vaccination was not associated with a significantly increased risk of congenital defects (pooled RR 1.25, 95% CI 0.99–1.56) (Table 3).…”

Section: Resultsmentioning

confidence: 99%

“…For the four studies with first-trimester exposure, the pooled rate of congenital defects was 0% (95% CI 0.0–0.0%). 6,11,20,25,26,30,31 …”

Section: Resultsmentioning

confidence: 99%

“…6,8,19,21–24,26,28,30,31 Among eight studies that included a comparison group, there was no significantly increased risk of stillbirth with smallpox vaccination (pooled RR 1.03, 95% CI 0.75–1.40) (Table 3). Stillbirth rates ranged from 1.5% to 4.2% among women vaccinated at any time during pregnancy, 0.9–14.7% among those vaccinated in the first trimester, and 1.2–3.9% among the unexposed cohort.…”

Section: Resultsmentioning

confidence: 99%

“…8,19,28 The proportional meta-analysis of four studies without a comparison group found an overall rate of stillbirth of 4% (95% CI 2–6%). 6,26,30,31 …”

Section: Resultsmentioning

confidence: 99%

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Risks Associated With Smallpox Vaccination in Pregnancy

Badell

Meaney‐Delman

Tuuli

et al. 2015

Obstetrics &Amp; Gynecology

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Objective To estimate the maternal and fetal risks of smallpox vaccination during pregnancy. Data Sources MEDLINE, Web of Science, EMBASE, Global Health, ClinicalTrials.gov, and CINHAL from inception to September 2014. Methods of Study Selection We included published articles containing primary data regarding smallpox vaccination during pregnancy that reported maternal or fetal outcomes (spontaneous abortion, congenital defect, stillbirth, preterm birth, or fetal vaccinia). Tabulations, Integration, and Results The primary search yielded 887 articles. After hand-searching, 37 articles were included: 18 articles with fetal outcome data and 19 case reports of fetal vaccinia. Outcomes of smallpox vaccination in 12,201 pregnant women were included. Smallpox vaccination was not associated with an increased risk of spontaneous abortion (pooled relative risk [RR] 1.03, confidence interval [CI] 0.76–1.41), stillbirth (pooled RR 1.03, CI 0.75–1.40), or preterm birth (pooled RR 0.84, CI 0.62–1.15). When vaccination in any trimester was considered, smallpox vaccination was not associated with an increased risk of congenital defects (pooled RR 1.25, CI 0.99–1.56); however, first-trimester exposure was associated with an increased risk of congenital defects (2.4% compared with 1.5%, pooled RR 1.34, CI 1.02–1.77). No cases of fetal vaccinia were reported in the studies examining fetal outcomes; 21 cases of fetal vaccinia were identified in the literature, of which three neonates survived. Conclusion The overall risk associated with maternal smallpox vaccination appears low. No association between smallpox vaccination and spontaneous abortion, preterm birth, or stillbirth was identified. First-trimester vaccination was associated with a small increase in congenital defects, but the effect size was small and based on limited data. Fetal vaccinia appears to be a rare consequence of maternal smallpox vaccination but is associated with a high rate of fetal loss.

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