The Maternal Vaccine Study Protocol: A Victorian Cohort Study Evaluating Infant and Childhood Safety and Health and Developmental Outcomes After Vaccination Against Respiratory Viruses in Pregnancy

Objectives: Changes in public policy are eroding vaccine confidence. Previously accepted peer-reviewed evidence around vaccination and developmental outcomes for children is being questioned. Robust, methodologically sound safety data are more needed than ever to maintain consumer confidence. Establishing further safety data on infant health, development, and allergies after COVID-19 and influenza vaccination in pregnancy may improve confidence and acceptance. Methods: This is a state-wide multi-centre prospective cohort study conducted as a sub-study of the Generation Victoria birth cohort. It will examine the risk difference for infant health, developmental, and allergy outcomes between groups of mother–baby pairs who will be examined according to exposure (vaccination against a respiratory virus during pregnancy) and comparator (no vaccination against a respiratory virus). Results: Data contributing to the analysis include GenV-collected developmental, health, and allergy outcomes to 12 months of age, as well as data from state-wide linked datasets. Conclusions: This linked-data longitudinal study will provide information on health, allergy, and developmental outcomes for infants in the first year of life after influenza and COVID-19 vaccination during pregnancy. Implications for Public Health: The reporting of developmental data will be a new contribution to knowledge around outcomes after vaccination during pregnancy.