Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Aug 2;12(8):1952-1959.
doi: 10.1080/21645515.2016.1186312. Epub 2016 May 31.

A systematic review of ethical issues in vaccine studies involving pregnant women

Jennifer A Beeler  1 , Philipp Lambach  2 , T Roice Fulton  1   3 , Divya Narayanan  1   3 , Justin R Ortiz  2 , Saad B Omer  1   3   4   5
Affiliations

A systematic review of ethical issues in vaccine studies involving pregnant women

Jennifer A Beeler et al. Hum Vaccin Immunother. .

Abstract

Background: Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy.

Aims: To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women.

Method: We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories.

Results: Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs.

Conclusion: This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs developed to prevent disease in newborn children in low- and middle-income countries.

Keywords: ethics; maternal immunization; vaccinology.

PubMed Disclaimer

References

    1. WHO UNICEF World Bank State of the world's vaccines and immunization. 3rd ed. 2009, Geneva: World Health Organization
    1. Makris MC, Polyzos KA, Mavros MN, Athanasiou S, Rafailidis PI, Falagas ME. Safety of hepatitis B, pneumococcal polysaccharide and meningococcal polysaccharide vaccines in pregnancy: a systematic review. Drug Saf 2012; 35(1):1-14; PMID:22149417; http://dx.doi.org/10.2165/11595670-000000000-00000 - DOI - PubMed
    1. Omer SB, Goodman D, Steinhoff MC, Rochat R, Klugman KP, Stoll BJ, Ramakrishnan U. Maternal influenza immunization and reduced likelihood of prematurity and small for gestational age births: a retrospective cohort study. PLoS Med 2011; 8(5):e1000441; PMID:21655318; http://dx.doi.org/10.1371/journal.pmed.1000441 - DOI - PMC - PubMed
    1. Macroepidemiology of Influenza Vaccination Study, G . The macro-epidemiology of influenza vaccination in 56 countries, 1997–2003. Vaccine 2005; 23(44):5133-43; PMID:16039762; http://dx.doi.org/10.1016/j.vaccine.2005.06.010 - DOI - PubMed
    1. van Essen GA, Palache AM, Forleo E, Fedson DS. Influenza vaccination in 2000: recommendations and vaccine use in 50 developed and rapidly developing countries. Vaccine 2003; 21(16):1780-5; PMID:12686094; http://dx.doi.org/10.1016/S0264-410X(03)00072-0 - DOI - PubMed

Publication types

LinkOut - more resources