The Health of Pregnant Women and Their Unborn Children– Neglected in Vaccine Development

IF 1.6 4区医学 Q4 DEVELOPMENTAL BIOLOGY

Birth Defects Research Pub Date : 2025-05-19 DOI:10.1002/bdr2.2483

Peter Selley, David Healy

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引用次数: 0

Abstract

Background

Randomized Controlled Trials of vaccines given in pregnancy aimed at benefitting the unborn child began in 2015. Their use for licensing purposes now appears established. These trials generate data on possible benefits and harms to infants but also on maternal health impacts. The International Council on Regulations for Pharmaceutical Use in Humans has realized that current safety regulations are not adequate for clinical trials in the second half of pregnancy. They are now drawing up improved guidelines for the conduct of these trials.

Aims

To focus attention on maternal and fetal health that his new willingness to run trials in pregnancy brings into the frame.

Materials and Methods

We reviewed all recent maternal vaccine trials and their outcomes, along with potential concerns.

Results

Analysis of data from recent trials of vaccines given in pregnancy suggests that they may be associated with adverse events during the pregnancy that affect both the mother and the fetus.

Discussion

The aim of vaccine trials in pregnancy currently centres on measuring the efficacy of prevention of infectious disease, and perinatal outcome. Study of the impact of maternal vaccines on pregnancy physiology has been neglected. New, rapidly developing areas, such as epigenomics, need to be considered. It is a good time for the wider field to have an input on what might be included in the guidelines, and whether other measures are needed.

Conclusion

Insufficient attention has been given to monitoring the health of pregnant women and of their fetus during vaccine trials. The need for new guidelines offers an opportunity to require more stringent safety monitoring during pregnancy which will benefit women and their unborn children.

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孕妇及其未出生婴儿的健康——在疫苗开发中被忽视

背景：旨在使未出生婴儿受益的妊娠期疫苗随机对照试验始于2015年。它们用于许可目的现在似乎已经确立。这些试验产生了对婴儿可能的益处和危害以及对孕产妇健康影响的数据。国际人体药物使用法规理事会已经意识到，目前的安全法规不适用于妊娠后半期的临床试验。他们现在正在为进行这些试验起草改进的指导方针。目的将人们的注意力集中在母体和胎儿健康上，这是他在怀孕期间进行试验的新意愿带来的。材料和方法我们回顾了最近所有的孕产妇疫苗试验及其结果，以及潜在的问题。结果：对近期妊娠期接种疫苗试验数据的分析表明，疫苗接种可能与妊娠期间影响母亲和胎儿的不良事件有关。妊娠期疫苗试验的目的目前集中在衡量预防传染病的效力和围产期结局。母体疫苗对妊娠生理影响的研究一直被忽视。需要考虑新的、快速发展的领域，如表观基因组学。对于更广泛的领域来说，现在是一个很好的时机，可以对指南中可能包括的内容以及是否需要采取其他措施提出意见。结论在疫苗试验过程中对孕妇及其胎儿的健康监测重视不够。需要制定新的指导方针提供了一个机会，要求在怀孕期间进行更严格的安全监测，这将有利于妇女及其未出生的孩子。

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

Birth Defects Research Medicine-Embryology

CiteScore

3.60

自引率

9.50%

发文量

153

期刊介绍： The journal Birth Defects Research publishes original research and reviews in areas related to the etiology of adverse developmental and reproductive outcome. In particular the journal is devoted to the publication of original scientific research that contributes to the understanding of the biology of embryonic development and the prenatal causative factors and mechanisms leading to adverse pregnancy outcomes, namely structural and functional birth defects, pregnancy loss, postnatal functional defects in the human population, and to the identification of prenatal factors and biological mechanisms that reduce these risks. Adverse reproductive and developmental outcomes may have genetic, environmental, nutritional or epigenetic causes. Accordingly, the journal Birth Defects Research takes an integrated, multidisciplinary approach in its organization and publication strategy. The journal Birth Defects Research contains separate sections for clinical and molecular teratology, developmental and reproductive toxicology, and reviews in developmental biology to acknowledge and accommodate the integrative nature of research in this field. Each section has a dedicated editor who is a leader in his/her field and who has full editorial authority in his/her area.