Cargando…

Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola

During the 2014–2016 Ebola epidemic, Médecins Sans Frontières (MSF) treated Ebola-positive pregnant women in its Ebola Treatment Centers (ETCs). For pregnant women with confirmed Ebola virus disease, inclusion in clinical vaccine/drug/therapeutic trials was complicated. Despite their extremely high...

Descripción completa

Detalles Bibliográficos
Autor principal: Caluwaerts, Séverine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5751508/
https://www.ncbi.nlm.nih.gov/pubmed/29297408
http://dx.doi.org/10.1186/s12978-017-0429-8
_version_ 1783289960104722432
author Caluwaerts, Séverine
author_facet Caluwaerts, Séverine
author_sort Caluwaerts, Séverine
collection PubMed
description During the 2014–2016 Ebola epidemic, Médecins Sans Frontières (MSF) treated Ebola-positive pregnant women in its Ebola Treatment Centers (ETCs). For pregnant women with confirmed Ebola virus disease, inclusion in clinical vaccine/drug/therapeutic trials was complicated. Despite their extremely high Ebola-related mortality in previous epidemics (89–93%) and a neonatal mortality of 100%, theoretical concerns about safety of vaccines and therapeutics in pregnancy were invoked, limiting pregnant women’s access to an experimental live attenuated vaccine and brincidofovir, an experimental antiviral. Favipiravir, another experimental antiviral, was made available to pregnant women only after extensive negotiations and under a ‘Monitored Emergency Use of Unregistered and Experimental Interventions’ (MEURI) protocol. This paper describes the case of a pregnant woman who presented to the ETCs near the end of the Ebola epidemic in Guinea. The pregnant patient was admitted with confirmed Ebola disease. She was previously denied access to potentially protective vaccination due to pregnancy, and access to experimental ZMapp was only possible through a randomized clinical trial (presenting a 50% chance of not receiving ZMapp). She received favipiravir, but died of Ebola-related complications. The infant, born in the ETC, tested positive for Ebola at birth. The infant received ZMapp (under MEURI access outside of the clinical trial), an experimental drug GS5734, and a buffy coat of an Ebola survivor, and survived. Though the infant did have access to experimental therapeutics within 24 h of birth, access to other experimental compounds for her mother was denied, raising serious ethical concerns.
format Online
Article
Text
id pubmed-5751508
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-57515082018-01-05 Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola Caluwaerts, Séverine Reprod Health Research During the 2014–2016 Ebola epidemic, Médecins Sans Frontières (MSF) treated Ebola-positive pregnant women in its Ebola Treatment Centers (ETCs). For pregnant women with confirmed Ebola virus disease, inclusion in clinical vaccine/drug/therapeutic trials was complicated. Despite their extremely high Ebola-related mortality in previous epidemics (89–93%) and a neonatal mortality of 100%, theoretical concerns about safety of vaccines and therapeutics in pregnancy were invoked, limiting pregnant women’s access to an experimental live attenuated vaccine and brincidofovir, an experimental antiviral. Favipiravir, another experimental antiviral, was made available to pregnant women only after extensive negotiations and under a ‘Monitored Emergency Use of Unregistered and Experimental Interventions’ (MEURI) protocol. This paper describes the case of a pregnant woman who presented to the ETCs near the end of the Ebola epidemic in Guinea. The pregnant patient was admitted with confirmed Ebola disease. She was previously denied access to potentially protective vaccination due to pregnancy, and access to experimental ZMapp was only possible through a randomized clinical trial (presenting a 50% chance of not receiving ZMapp). She received favipiravir, but died of Ebola-related complications. The infant, born in the ETC, tested positive for Ebola at birth. The infant received ZMapp (under MEURI access outside of the clinical trial), an experimental drug GS5734, and a buffy coat of an Ebola survivor, and survived. Though the infant did have access to experimental therapeutics within 24 h of birth, access to other experimental compounds for her mother was denied, raising serious ethical concerns. BioMed Central 2017-12-14 /pmc/articles/PMC5751508/ /pubmed/29297408 http://dx.doi.org/10.1186/s12978-017-0429-8 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Caluwaerts, Séverine
Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola
title Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola
title_full Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola
title_fullStr Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola
title_full_unstemmed Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola
title_short Nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola
title_sort nubia’s mother: being pregnant in the time of experimental vaccines and therapeutics for ebola
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5751508/
https://www.ncbi.nlm.nih.gov/pubmed/29297408
http://dx.doi.org/10.1186/s12978-017-0429-8
work_keys_str_mv AT caluwaertsseverine nubiasmotherbeingpregnantinthetimeofexperimentalvaccinesandtherapeuticsforebola