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Review
. 2021 Jan 3;39(1):85-120.
doi: 10.1016/j.vaccine.2019.01.011. Epub 2019 May 3.

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response

Carleigh B Krubiner  1 , Ruth R Faden  2 , Ruth A Karron  3 , Margaret O Little  4 , Anne D Lyerly  5 , Jon S Abramson  6 , Richard H Beigi  7 , Alejandro R Cravioto  8 , Anna P Durbin  3 , Bruce G Gellin  9 , Swati B Gupta  10 , David C Kaslow  11 , Sonali Kochhar  12 , Florencia Luna  13 , Carla Saenz  14 , Jeanne S Sheffield  15 , Paulina O Tindana  16 ; PREVENT Working Group
Affiliations
Review

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response

Carleigh B Krubiner et al. Vaccine. .

Abstract

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely - and at times uniquely - affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group - a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy - in consultation with a variety of external experts and stakeholders.

Keywords: Emerging infectious diseases; Epidemics; Maternal immunization; Pregnancy; Public health ethics; Research & development; Research ethics; Vaccines.

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Conflict of interest statement

Conflict of interest disclosure RAK has received grants from the Bill and Melinda Gates Foundation and PATH as well as personal fees from MERCK, outside the submitted work. JSA served as the Chair of the Global Alliance for Vaccines and Immunizations (Gavi) Vaccine Investment Strategic (VIS) Steering Committee (June 2017 – present) as well as the Co-chair of the Vaccine Innovation Prioritization Strategy Alliance (Gavi, WHO, UNICEF, Gates and PATH) Steering Committee (July 2018 – present) during the conduct of this work. BGG is President, Global Immunization at the Sabin Vaccine Institute. Sabin receives support from the Bill and Melinda Gates Foundation, Gavi, the National Philanthropic Trust, and private philanthropy. In addition, Sabin receives project-specific support from GlaxoSmithKline, Merck & Co., Pfizer, Sanofi Pasteur, Takeda Vaccines, Inc. None of this support is related to the focus of the PREVENT Working Group or the published Guidance. DCK has grant support from the Bill and Melinda Gates Foundation for work outside the scope of this Guidance. DCK oversees PATH's Center for Vaccine Innovation and Access (CVIA), which has grants from by the Bill and Melinda Gates Foundation for related work, including Advancing Maternal Immunization. The other authors do not have conflicts of interest to declare.

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