Estimation of background rates of adverse events of special interest in neonatal outcomes: preterm births, stillbirths, neonatal deaths and low birthweight

Overview

During pregnancy, women and infants are predisposed to specific infections due to various immunological and physiological changes. These infections can result in adverse outcomes. The risk and severity of these infections can be attenuated through maternal vaccination, whose benefits have been demonstrated before. The World Health Organization (WHO) already recommends maternal vaccination against tetanus, pertussis and influenza to protect infants. The United States Food and Drug Administration has approved the first maternal respiratory syncytial virus vaccine, which may soon be introduced in low- and middle-income countries (LMICs). LMICs stand to benefit the most from these vaccines, because they have the highest burden of perinatal and infant mortality. It is crucial they develop safety monitoring beyond routine surveillance to inform current and future maternal vaccination programmes. The aim of this project is to prospectively generate evidence on background rates of four adverse events of special interest (AESIs) in multiple countries – preterm birth, stillbirth, neonatal death and low birthweight – before the introduction of novel vaccines such as maternal respiratory syncytial virus vaccine into national immunization programmes. The protocol will be piloted in LMICs with the potential for broader application.