A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women
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.
Benefit-risk, Emerging pathogens, Maternal vaccination, Pandemic, Safety surveillance, Template, Vaccines
Munoz, Flor M.
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Kampmann, Beate
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Stergachis, Andy
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Chaudhary, Manu
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Cutland, Clare L.
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Khalil, Asma
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Gentile, Angela
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Jones, Christine
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Marshall, Helen
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Sevene, Esperanca
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Darko, Delese Mimi
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Swamy, Geeta
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Hyde, Terri B.
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Voss, Gerald
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Muelen, Ajoke Sobanjo Ter
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30 August 2025
Munoz, Flor M.
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Kampmann, Beate
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Stergachis, Andy
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Chaudhary, Manu
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Cutland, Clare L.
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Khalil, Asma
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Gentile, Angela
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Jones, Christine
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Marshall, Helen
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Sevene, Esperanca
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Darko, Delese Mimi
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Swamy, Geeta
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Hyde, Terri B.
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Voss, Gerald
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Muelen, Ajoke Sobanjo Ter
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Munoz, Flor M., Kampmann, Beate, Stergachis, Andy, Chaudhary, Manu, Cutland, Clare L., Khalil, Asma, Gentile, Angela, Jones, Christine, Marshall, Helen, Sevene, Esperanca, Darko, Delese Mimi, Swamy, Geeta, Hyde, Terri B., Voss, Gerald and Muelen, Ajoke Sobanjo Ter
(2025)
A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women.
Vaccine, 62, [127513].
(doi:10.1016/j.vaccine.2025.127513).
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.
Text
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More information
Accepted/In Press date: 11 July 2025
e-pub ahead of print date: 18 July 2025
Published date: 30 August 2025
Additional Information:
Publisher Copyright:
© 2024
Keywords:
Benefit-risk, Emerging pathogens, Maternal vaccination, Pandemic, Safety surveillance, Template, Vaccines
Identifiers
Local EPrints ID: 504440
URI: http://eprints.soton.ac.uk/id/eprint/504440
ISSN: 0264-410X
PURE UUID: 7dad5337-91d0-487b-8568-114127808d15
Catalogue record
Date deposited: 09 Sep 2025 18:24
Last modified: 11 Sep 2025 02:53
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Contributors
Author:
Flor M. Munoz
Author:
Beate Kampmann
Author:
Andy Stergachis
Author:
Manu Chaudhary
Author:
Clare L. Cutland
Author:
Asma Khalil
Author:
Angela Gentile
Author:
Helen Marshall
Author:
Esperanca Sevene
Author:
Delese Mimi Darko
Author:
Geeta Swamy
Author:
Terri B. Hyde
Author:
Gerald Voss
Author:
Ajoke Sobanjo Ter Muelen
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