A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women.

Vaccination during pregnancy provides effective protection against pathogens that increase the risk of maternal and infant morbidity and mortality for mothers and their infants. The SARS-CoV-2 pandemic demonstrated the need for the inclusion of pregnant and breast-feeding women in research and development of vaccines for emerging pathogens, such as Ebola, Zika, Lassa fever, Chikungunya, and influenza virus of pandemic potential. The COVID-19 Vaccines Global Access (COVAX) Maternal Immunization Working Group (MIWG), in collaboration with the Coalition for Epidemic Preparedness Innovation and the Safety Platform for Emergency Vaccines (CEPI-SPEAC) developed a standardized template with key considerations to guide the assessment of vaccines against emerging pathogens in pregnant and breast-feeding women. The aim of this tool is to enable key stakeholders to perform an early structured assessment of the overall potential benefit and risk for maternal immunization against an emerging pathogen. It can also be used to support risk management and pharmacovigilance planning, communication strategies, policy development, and acceptance of vaccination during pregnancy in future pandemics.