Who's the Target: Mother or Baby?

Maternal immunization for prevention of morbidity and mortality of pregnant women and their neonates due to infectious diseases is ongoing worldwide. The complexity of vaccine research and development in this population is challenging. Not only do vaccines for pregnant women require evidence of immunogenicity, potency, stability, and limited reactogenicity, they must also provide efficacy in decreasing morbidity for the pregnant woman, her fetus, and the neonate, demonstrate safety or lack of evidence of harm, and offer benefit or potential benefit of vaccination during pregnancy. Since the 19th century, evidence of protective effects of vaccination during pregnancy has been documented. Pandemic influenza and pertussis outbreaks in recent years have affected a paradigm shift in vaccine research and development as well as current policy regarding immunization in pregnancy. Studies of the immune system in pregnant women and neonates have shown that immune changes associated with pregnancy in women do not interfere with maternal vaccine responses, multiple factors are important in transplacental transfer of antibodies, and maternal antibodies are beneficial to neonates. In recent years, guidelines have been developed by expert panels to help design studies for maternal vaccinations and for harmonization of data collection, analysis, and adverse event reporting. Further research into maternal and neonatal immunology, transplacental antibody transfer, and epidemiology of diseases is needed, especially as new vaccines to respiratory syncytial virus, cytomegalovirus, and Group B streptococcus are developed. Maternal vaccinations have the potential to change the epidemiology of infectious diseases in reproductive health and pediatrics and may lead to new clinical applications to improve global maternal and neonatal health.