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Review
. 2025 Aug 30:62:127513.
doi: 10.1016/j.vaccine.2025.127513. Epub 2025 Jul 18.

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

Flor M Munoz  1 , Beate Kampmann  2 , Andy Stergachis  3 , Manu Chaudhary  4 , Clare L Cutland  5 , Asma Khalil  6 , Angela Gentile  7 , Christine E Jones  8 , Helen Marshall  9 , Esperanca Sevene  10 , Delese Mimi Darko  11 , Geeta Swamy  12 , Terri B Hyde  13 , Gerald Voss  14 , Ajoke Sobanjo-Ter Muelen  15
Affiliations
Free article
Review

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

Flor M Munoz et al. Vaccine. .
Free article

Abstract

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.

Keywords: Benefit-risk; Emerging pathogens; Maternal vaccination; Pandemic; Safety surveillance; Template; Vaccines.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Flor M. Munoz reports a relationship with Pfizer that includes: consulting or advisory and funding grants. Flor M. Munoz reports a relationship with Moderna that includes: consulting or advisory. Flor M. Munoz reports a relationship with Meissa Vaccines that includes: consulting or advisory. Flor M. Muno reports a relationship with National Foundation of Infectious Diseases that includes: board membership. Clare L. Cutland reports a relationship with Bill & Melinda Gates Foundation that includes: funding grants. Clare L. Cutland reports a relationship with Pfizer that includes: funding grants. Clare L. Cutland reports a relationship with German Society for International Cooperation (GIZ) GmbH that includes: funding grants. Helen Marshall reports a relationship with Sanofi Pasteur that includes: funding grants. Helen Marshall reports a relationship with Seqirus that includes: funding grants. Helen Marshall reports a relationship with Moderna that includes: funding grants. Helen Marshall reports a relationship with ILiAD Biotechnologies that includes: funding grants. Geeta Swamy reports a relationship with Pfizer that includes: consulting or advisory. Geeta Swamy reports a relationship with GSK that includes: consulting or advisory and speaking and lecture fees. Geeta Swamy reports a relationship with Moderna that includes: consulting or advisory. Geeta Swamy reports a relationship with Sanofi Pasteur that includes: speaking and lecture fees. Corresponding author is an associate editor for Vaccine and a member of the ACOG Immunization Expert Group-FMM Co-author was a member of the Brighton Collaboration Scientific Committee 2018–2023-CLC Co-author is a contributor to UpRoDate on listeria in pregnancy and a Medscape educational contributor on congential CMV - GS. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.