Adverse event following immunization surveillance systems for pregnant women and their infants: a systematic review

Background: The World Health Organization's Strategic Advisory Group of Experts on Immunization has declared that maternal immunization is a key priority. Robust adverse event following immunization (AEFI) surveillance systems that capture outcomes in pregnant women and their infants are needed to ensure the safety of maternal immunization programs. We sought to identify the active and passive AEFI surveillance systems for pregnant women and their offspring described in the literature.

Methods: A systematic literature review was conducted of the MEDLINE, CINAHL, and EMBASE databases from 1990 to 2014. English-language articles were reviewed if they included pregnant women as the population of interest and described the surveillance method used.

Results: Of 619 articles retrieved from the search, 16 met the criteria for review. These included reports of AEFI surveillance for pregnant women, their offspring, or both. The majority of reports (11/16) came from the USA and described findings on two active and four passive AEFI surveillance systems, only three of which specifically targeted pregnant women. The remaining five articles described one-time AEFI surveillance programs, all in high-income countries.

Conclusion: There are no published reports outside of the USA of ongoing AEFI surveillance systems that specifically target pregnant women or their offspring. There may be AEFI surveillance systems that capture events in these populations that have not been reported in the literature. A survey of immunization program managers and national regulatory authorities is needed to determine the current status of AEFI surveillance for pregnant women and their offspring globally.