title: Analysis of pregnancy and infant health outcomes among women in the National Smallpox Vaccine in Pregnancy Registry who received Anthrax Vaccine Adsorbed.
abstract: The National Smallpox Vaccine in Pregnancy Registry (NSVIPR) actively follows women inadvertently vaccinated with smallpox vaccine during or shortly before pregnancy to evaluate their reproductive health outcomes. Approximately 65% of NSVIPR participants also inadvertently received Anthrax Vaccine Adsorbed (AVA) while pregnant, providing a ready opportunity to evaluate pregnancy and infant health outcomes among these women. AVA-exposed pregnancies were ascertained using NSVIPR and electronic healthcare data. Rates of pregnancy loss and infant health outcomes, including major birth defects, were compared between AVA-exposed and AVA-unexposed pregnancies. Analyses included AVA-exposed and AVA-unexposed pregnant women who also received smallpox vaccine 28 days prior to or during pregnancy. Rates of adverse outcomes among the AVA-exposed group were similar to or lower than expected when compared with published reference rates and the AVA-unexposed population. The findings provide reassurance of the safety of AVA when inadvertently received by a relatively young and healthy population during pregnancy.
authors.affiliation: Deployment Health Research Department, Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, USA. Electronic address: avamarie.s.conlin.ctr@mail.mil.
authors.forename: Ava Marie S
authors.initials: AM
authors.lastname: Conlin
authors.affiliation: Deployment Health Research Department, Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, USA.
authors.forename: Anna T
authors.initials: AT
authors.lastname: Bukowinski
authors.affiliation: Deployment Health Research Department, Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, USA.
authors.forename: Gia R
authors.initials: GR
authors.lastname: Gumbs
mesh_terms: D000328:Adult; D022122:Anthrax Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007223:Infant; D000068104:Infant Health; D007231:Infant, Newborn; D008297:Male; D018811:Maternal Exposure; D011247:Pregnancy; D011256:Pregnancy Outcome; D012900:Smallpox Vaccine / Q000008:administration & dosage* / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D022122:Anthrax Vaccines; D012900:Smallpox Vaccine
keywords: Anthrax Vaccine Adsorbed (AVA); Congenital abnormalities; Maternal exposure; Pregnancy outcome