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Vaccine. 2019 May 31;37(25):3267-3277. doi: 10.1016/j.vaccine.2019.04.075. Epub 2019 May 6.

Introduction of new vaccines for immunization in pregnancy - Programmatic, regulatory, safety and ethical considerations.

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Global Healthcare Consulting, New Delhi, India; Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, the Netherlands; Department of Global Health, University of Washington, Seattle, USA. Electronic address:
Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, TN, USA.
Comprehensive Family Immunization Unit, Department of Family, Health Promotion and Life Course (FPL). Pan American Health Organization (PAHO/WHO), Washington DC, USA.
Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, USA.
Department of Global Health, University of Washington, Seattle, USA; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.


Immunizing pregnant women is a promising strategy to reduce infectious disease-related morbidity and mortality in pregnant women and their infants. Important pre-requisites for the successful introduction of new vaccines for immunization in pregnancy include political commitment and adequate financial resources: trained, committed and sufficient numbers of healthcare workers to deliver the vaccines; close integration of immunization programs with antenatal care and Maternal and Child Health services; adequate access to antenatal care by pregnant women in the country (especially in low and middle-income countries (LMIC)); and a high proportion of births occurring in health facilities (to ensure maternal and neonatal follow-up can be done). The framework needed to advance a vaccine program from product licensure to successful country-level implementation includes establishing and organizing evidence for anticipated vaccine program impact, developing supportive policies, and translating policies into local action. International and national coordination efforts, proactive planning from conception to implementation of the programs (including country-level policy making, planning, and implementation, regulatory guidance, pharmacovigilance) and country-specific and cultural factors must be taken into account during the vaccines introduction.


Antenatal care; Country-level policy making; Global policies; Health policies; Healthcare providers; Immunisation; Introduction; Maternal Immunization; Pharmacovigilance; Pregnancy; Program; Regulatory; Safety; Vaccination coverage; Vaccine hesitancy; Vaccines

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