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

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-07-18 DOI:10.1016/j.vaccine.2025.127513

Flor M. Munoz , Beate Kampmann , Andy Stergachis , Manu Chaudhary , Clare L. Cutland , Asma Khalil , Angela Gentile , Christine E. Jones , Helen Marshall , Esperanca Sevene , Delese Mimi Darko , Geeta Swamy , Terri B. Hyde , Gerald Voss , Ajoke Sobanjo-Ter Muelen

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引用次数: 0

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.

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用于评估用于孕妇和哺乳期妇女的新发病原体疫苗的模板工具

怀孕期间接种疫苗可有效预防增加母婴发病率和死亡率风险的病原体。SARS-CoV-2大流行表明，有必要将孕妇和哺乳期妇女纳入针对埃博拉、寨卡、拉沙热、基孔肯雅热和可能大流行的流感病毒等新出现病原体的疫苗研发。COVID-19疫苗全球获取（COVAX）孕产妇免疫工作组（MIWG）与流行病防范创新联盟和应急疫苗安全平台（CEPI-SPEAC）合作，制定了一个包含关键考虑因素的标准化模板，以指导对孕妇和哺乳期妇女新发病原体疫苗的评估。该工具的目的是使主要利益攸关方能够对针对新出现病原体的孕产妇免疫接种的总体潜在利益和风险进行早期结构化评估。它还可用于支持风险管理和药物警戒规划、沟通战略、政策制定以及在未来的大流行中接受怀孕期间的疫苗接种。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.