title: A global survey of adverse event following immunization surveillance systems for pregnant women and their infants.
abstract: Strengthening antenatal care as a platform for maternal immunization is a priority of the World Health Organization (WHO). Systematic surveillance for adverse events following immunization (AEFI) in pregnancy is needed to identify vaccine safety events. We sought to identify active and passive AEFI surveillance systems for pregnant women and infants. Representatives from all National Pharmacovigilance Centers and a convenience sample of vaccine safety experts were invited to complete a 14-item online survey in English, French or Spanish. The survey captured maternal immunization policies, and active and passive AEFI surveillance systems for pregnant women and infants in respondents' countries. The analysis was descriptive. We received responses from 51/185 (28%) invited persons from 47/148 (32%) countries representing all WHO regions, and low, middle and high-income countries. Thirty countries had national immunization policies targeting pregnant women. Eleven countries had active surveillance systems to detect serious AEFI in pregnant women and/or their infants, including six low and middle-income countries (LMIC). Thirty-nine countries had passive surveillance systems, including 23 LMIC. These active and passive surveillance programs cover approximately 8% and 56% of the worldwide annual birth cohort, respectively. Data from one active and four passive systems have been published. We identified 50 active and passive AEFI surveillance systems for pregnant women and infants, but few have published their findings. AEFI surveillance appears to be feasible in low and high resource settings. Further expansion of AEFI surveillance for pregnant women and sharing of vaccine safety information will provide additional evidence in support of maternal immunization policies.
authors.affiliation: a School of Nursing, Faculty of Health Professions, Dalhousie University , Halifax , Nova Scotia , Canada.
authors.forename: Christine
authors.initials: C
authors.lastname: Cassidy
authors.affiliation: b Department of Pediatrics , Dalhousie University , Halifax , Nova Scotia , Canada.|c Canadian Center for Vaccinology, IWK Health Center , Halifax , Nova Scotia , Canada.
authors.forename: Noni E
authors.initials: NE
authors.lastname: MacDonald
authors.affiliation: a School of Nursing, Faculty of Health Professions, Dalhousie University , Halifax , Nova Scotia , Canada.|c Canadian Center for Vaccinology, IWK Health Center , Halifax , Nova Scotia , Canada.
authors.forename: Audrey
authors.initials: A
authors.lastname: Steenbeek
authors.affiliation: d Initiative for Vaccine Research, World Health Organization , Geneva , Switzerland.
authors.forename: Justin R
authors.initials: JR
authors.lastname: Ortiz
authors.affiliation: d Initiative for Vaccine Research, World Health Organization , Geneva , Switzerland.
authors.forename: Patrick L F
authors.initials: PL
authors.lastname: Zuber
authors.affiliation: b Department of Pediatrics , Dalhousie University , Halifax , Nova Scotia , Canada.|c Canadian Center for Vaccinology, IWK Health Center , Halifax , Nova Scotia , Canada.
authors.forename: Karina A
authors.initials: KA
authors.lastname: Top
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D062665:Epidemiological Monitoring; D005260:Female; D014943:Global Health; D006291:Health Policy; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007223:Infant; D007231:Infant, Newborn; D011247:Pregnancy
keywords: adverse event following immunization; neonate; pregnancy; surveillance; vaccination