Need for developing case definitions and guidelines for data collection, analysis, and presentation for dysfunctional labor as an adverse event following immunization
Vaccination during pregnancy is recommended for both maternal and neonatal benefit against a number of potential infections. The tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine is now routine recommended for pregnant women in each pregnancy not only for maternal benefit, but to confer passive antibody transfer to the newborn until infant immunizations can be given [1]. Influenza vaccinations are also strongly recommended for any pregnant woman, or women who might become pregnant during influenza seasons [2]. The safety of both these vaccinations has been well established. Efforts to develop new vaccinations for use during pregnancy represent a new opportunity to prevent common maternal and neonatal infections with severe morbidity and mortality. There is growing interest and research around maternal immunization against both Group B streptococcus (GBS) and Respiratory syncytial virus (RSV) as a public health strategy to prevent neonatal and infant infections worldwide [3], [4].
Establishing the safety profile of any new vaccination requires careful surveillance of potential adverse effects and consistent terminology and definitions across context and time. The World Health Organization (WHO) defines an ‘adverse event following immunization’ (AEFI) as “any untoward medical occurrence which follows immunization and, which does not necessarily have a causal relationship with the use of the vaccine. The adverse event may be an unfavorable or unintended sign, an abnormal laboratory finding, a symptom or disease” [5]. Recognizing that vaccination is often temporally related to many events, abnormal findings or diseases, causality assessment between an AEFI and vaccination requires further rigorous assessment and study. Monitoring of a broad array of events, including those without established or suspected links to vaccine can therefore provide the initial basis for data with which such causality can be proven or disproven.
