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

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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.

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Most cited references 147

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Understanding vaccine hesitancy around vaccines and vaccination from a global perspective: a systematic review of published literature, 2007-2012.

Heidi Larson, Caitlin Jarrett, Elisabeth Eckersberger … (2014)

Vaccine "hesitancy" is an emerging term in the literature and discourse on vaccine decision-making and determinants of vaccine acceptance. It recognizes a continuum between the domains of vaccine acceptance and vaccine refusal and de-polarizes previous characterization of individuals and groups as either anti-vaccine or pro-vaccine. The primary aims of this systematic review are to: 1) identify research on vaccine hesitancy; 2) identify determinants of vaccine hesitancy in different settings including its context-specific causes, its expression and its impact; and 3) inform the development of a model for assessing determinants of vaccine hesitancy in different settings as proposed by the Strategic Advisory Group of Experts Working Group (SAGE WG) for dealing with vaccine hesitancy. A broad search strategy, built to capture multiple dimensions of public trust, confidence and hesitancy around vaccines, was applied across multiple databases. Peer-reviewed studies were selected for inclusion if they focused on childhood vaccines [≤ 7 years of age], used multivariate analyses, and were published between January 2007 and November 2012. Our results show a variety of factors as being associated with vaccine hesitancy but they do not allow for a complete classification and confirmation of their independent and relative strength of influence. Determinants of vaccine hesitancy are complex and context-specific - varying across time, place and vaccines. Copyright © 2014 Elsevier Ltd. All rights reserved.

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Updating the accounts: global mortality of the 1918-1920 "Spanish" influenza pandemic.

Juergen Mueller, Justin S. Hogg (2001)

The influenza pandemic of 1918-20 is recognized as having generally taken place in three waves, starting in the northern spring and summer of 1918. This pattern of three waves, however, was not universal: in some locations influenza seems to have persisted into or returned in 1920. The recorded statistics of influenza morbidity and mortality are likely to be a significant understatement. Limitations of these data can include nonregistration, missing records, misdiagnosis, and nonmedical certification, and may also vary greatly between locations. Further research has seen the consistent upward revision of the estimated global mortality of the pandemic, which a 1920s calculation put in the vicinity of 21.5 million. A 1991 paper revised the mortality as being in the range 24.7-39.3 million. This paper suggests that it was of the order of 50 million. However, it must be acknowledged that even this vast figure may be substantially lower than the real toll, perhaps as much as 100 percent understated.

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Zika Virus Infection in Pregnant Women in Rio de Janeiro - Preliminary Report.

P Brasil, J.P. Pereira, M.E. Moreira … (2016)

Background Zika virus (ZIKV) has been linked to neonatal microcephaly. To characterize the spectrum of ZIKV disease in pregnancy, we followed patients in Rio de Janeiro to describe clinical manifestations in mothers and repercussions of acute ZIKV infection in fetuses. Methods We enrolled pregnant women in whom a rash had developed within the previous 5 days and tested blood and urine specimens for ZIKV by reverse-transcriptase-polymerase-chain-reaction assays. We followed the women prospectively and collected clinical and ultrasonographic data. Results A total of 88 women were enrolled from September 2015 through February 2016; of these 88 women, 72 (82%) tested positive for ZIKV in blood, urine, or both. The timing of acute ZIKV infection ranged from 5 to 38 weeks of gestation. Predominant clinical features included pruritic descending macular or maculopapular rash, arthralgias, conjunctival injection, and headache; 28% had fever (short-term and low-grade). Women who were positive for ZIKV were more likely than those who were negative for the virus to have maculopapular rash (44% vs. 12%, P=0.02), conjunctival involvement (58% vs. 13%, P=0.002), and lymphadenopathy (40% vs. 7%, P=0.02). Fetal ultrasonography was performed in 42 ZIKV-positive women (58%) and in all ZIKV-negative women. Fetal abnormalities were detected by Doppler ultrasonography in 12 of the 42 ZIKV-positive women (29%) and in none of the 16 ZIKV-negative women. Adverse findings included fetal deaths at 36 and 38 weeks of gestation (2 fetuses), in utero growth restriction with or without microcephaly (5 fetuses), ventricular calcifications or other central nervous system (CNS) lesions (7 fetuses), and abnormal amniotic fluid volume or cerebral or umbilical artery flow (7 fetuses). To date, 8 of the 42 women in whom fetal ultrasonography was performed have delivered their babies, and the ultrasonographic findings have been confirmed. Conclusions Despite mild clinical symptoms, ZIKV infection during pregnancy appears to be associated with grave outcomes, including fetal death, placental insufficiency, fetal growth restriction, and CNS injury.

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Author and article information

Contributors

Carleigh B. Krubiner

Journal

Journal ID (nlm-ta): Vaccine

Journal ID (iso-abbrev): Vaccine

Title: Vaccine

Publisher: Elsevier Science

ISSN (Print): 0264-410X

ISSN (Electronic): 1873-2518

Publication date PMC-release: 03 January 2021

Publication date (Print): 03 January 2021

Volume: 39

Issue: 1

Pages: 85-120

Affiliations

[a ]Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Avenue, Baltimore, MD, USA

[b ]Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

[c ]Kennedy Institute of Ethics, Georgetown University, Washington, D.C., USA

[d ]University of North Carolina Center for Bioethics, Chapel Hill, NC, USA

[e ]Wake Forest University School of Medicine, Winston-Salem, NC, USA

[f ]Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA

[g ]Universidad Nacional Autónoma de México, Mexico City, Mexico

[h ]Sabin Vaccine Institute, Washington, D.C., USA

[i ]IAVI, New York, NY, USA

[j ]PATH, Seattle, WA, USA

[k ]Global Healthcare Consulting, Delhi, India

[l ]FLACSO-Argentina & CONICET, Buenos Aires, Argentina

[m ]Pan American Health Organization, Washington, D.C., USA

[n ]Johns Hopkins University School of Medicine, Baltimore, MD, USA

[o ]Navrongo Health Research Centre, Navrongo, Ghana

Author notes

[* ]Corresponding author at: 2055 L Street NW, 5th Floor, Washington, D.C. 20036, USA. ckrubiner@ 123456cgdev.org

[1]

Updated addresses and affiliations: Carleigh B. Krubiner is primarily affiliated with The Center for Global Development (address and contact information under corresponding author details reflect this current address).

[2]

Updated addresses and affiliations: The School of Public Health, College of Health Sciences, University of Ghana, P.O. Box LG13, Legon.

Article

Publisher Item ID: S0264-410X(19)30045-3

DOI: 10.1016/j.vaccine.2019.01.011

PMC ID: 7735377

PubMed ID: 31060949

SO-VID: b55d6fa0-0389-45de-afe6-0420c5df0b2f

License:

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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

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Zika Virus

Most cited references 147

Understanding vaccine hesitancy around vaccines and vaccination from a global perspective: a systematic review of published literature, 2007-2012.

Updating the accounts: global mortality of the 1918-1920 "Spanish" influenza pandemic.

Zika Virus Infection in Pregnant Women in Rio de Janeiro - Preliminary Report.

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