Pilot Program for Active Maternal Vaccine Safety Surveillance at KEMRI Wellcome Trust Research Programme (KWTRP)

Pilot program for active maternal vaccine safety surveillance using pregnancy registry approach in Kilifi, Kenya

• Maternal Immunization is one of the strategies that will help achieve the third sustainable development goal of ensuring healthy lives and promoting well-being for all at all ages by 2030, by reducing maternal and infant mortality. Maternal immunisation (MI) involves vaccination of pregnant women to induce immunity against the target pathogen. Maternal antibodies increase post vaccination and are transferred actively across the placental membranes into foetal blood, thereby providing protection to both mother and the baby or only to the foetus and newborn infant. Maternal immunisation using Tetanus toxoid(TT) vaccine has been in place in Kenya since 1980s, and has been used to successfully reduce the burden of neonatal tetanus. There is increased interest to develop new maternal vaccines that may reduce infant mortality by protecting babies against infectious diseases in early life. These new interventions, include new maternal vaccines for Respiratory Syncytial Virus and Group B Streptococcus which support these goals, through effective prevention of disease and death at and after birth. However, post-licensure, post-approval safety surveillance is needed to assess the safety of these new vaccines for pregnant women and their newborns, in real-world settings. This project aims to develop a pilot program for active maternal vaccine safety surveillance, using a pregnancy registry approach. The project will involve conducting Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis of hospital and community data capture systems of safety events following immunization and review of hospital-based vaccine safety data completeness through observation of small-scale data collection processes to infer the feasibility and acceptability of MI safety surveillance.