Accession Number:

ADA496867

Title:

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

Descriptive Note:

Journal article

Corporate Author:

NAVAL HEALTH RESEARCH CENTER SAN DIEGO CA

Personal Author(s):

Report Date:

2008-01-01

Pagination or Media Count:

8.0

Abstract:

Background Little information is available to describe the risks of smallpox vaccine administered in pregnancy, with the exception of known, rare cases of fetal vaccinia. When the United States implemented a smallpox vaccination program in 2003, the Smallpox Vaccine in Pregnancy Registry was established to better evaluate outcomes after the inadvertent vaccination of women in pregnancy. Methods The Registry developed a modified Vaccine Adverse Event Reporting System report to collect information from pregnant women after smallpox vaccination. Military healthcare providers were engaged to identify cases, since most smallpox vaccines were administered to military service members. Registry professionals actively follow all enrolled women through and after pregnancy. Results As of September 2006, pregnancy outcome data were available from 376 women followed by the Registry. Most 77 were vaccinated near the time of conception, before a standard pregnancy test would have been positive. Evaluations of outcomes to date have not revealed higher-than-expected rates of pregnancy loss 11.9, preterm birth 10.7, or birth defects 2.8, when compared to healthy referent populations. No cases of fetal vaccinia have been identified. Conclusions Close follow-up of women inadvertently vaccinated against smallpox during pregnancy, to date, has not revealed pregnancy, birth, or infant health problems attributable to smallpox vaccine exposure. The Smallpox Vaccine in Pregnancy Registry continues to actively enroll and follow women and infant and early childhood health outcomes.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE