When Is It Acceptable to Vaccinate Pregnant Women? Risk, Ethics, and Politics of Governance in Epidemic Crises

Abstract

Purpose of Review In some countries, pregnant women experience disproportionately high morbidity and mortality during infectious disease outbreaks due to a variety of gender-based factors and pregnancy-related immunological changes. Despite this, the interests of pregnant women have largely been absent from policies that guide the design of clinical trials and the deployment of vaccines in epidemic contexts. This review examines historic precedent for both excluding and including pregnant women in vaccine trials and considers the rights of pregnant women in epidemic crises. Recent Findings The latest research reveals that perceptions of risk and vulnerability of pregnant women in clinical research are beginning to change, resulting in modest policy and guideline amendments. A growing advocacy movement calling for Bfair inclusion^has played an important role. Summary Despite the global-scale and far-reaching implications of vaccine research policies, the current debate appears to reside primarily in disciplinary siloes across Western academic and policymaking spaces. Conceptual ambiguity of Brisk,^the pervasive view of pregnant women as Bvulnerable,^and competing ethical values that construct research protocols, globally, call for more explicit guidelines.

Potential Maternal and Infant Outcomes from Coronavirus 2019-nCoV (SARS-CoV-2) Infecting Pregnant Women: Lessons from SARS, MERS, and Other Human Coronavirus Infections

“…Safe testing of experimental vaccines in a pregnant population is difficult and, as a result, vaccines are not typically developed with pregnant women in mind. To date, very few clinical trials for vaccines have proactively included pregnant women [75], and the exclusion of pregnant and lactating women from receiving the rVSV-ZEBOV vaccine through 3 Ebola virus epidemics serves as a recent example [69][70][71]. Given the potential severity in pregnancy, as demonstrated by this review of maternal infections of SARS and MERS, women who are pregnant should be considered a priority population in all efforts to prepare for and prevent infection by novel coronaviruses.…”

COVAD survey 2 long-term outcomes: unmet need and protocol

“…Vaccine hesitancy is especially a concern in understudied and vulnerable populations, such as pregnant and lactating women, who were largely excluded from the initial vaccine safety trials. While additional data are required to determine the long-term effects of maternal reactogenicity, current evidence strongly suggests that the benefits of maternal vaccination outweigh the theoretical risks [ 16 ].…”

A reasoned approach towards administering COVID‐19 vaccines to pregnant women

“…However, during a pandemic, the balance between ‘benefit’ and ‘minimal harm’ might vary significantly when compared to a non‐pandemic situation. 130 For example, during the West African Ebola pandemic of 2013–2016, pregnant women faced a case fatality rate of 89%–93%. 131 While inclusion of pregnant women in drug and vaccine trials under such circumstances could have been justified, they were excluded despite the World Health Organisation Ethics Review Committee 132 recommending protocol amendments when there were no objective reasons to exclude pregnancy.…”

“…This exclusion may be a result of anticipated socio‐cultural complications if the vaccination program reports adverse pregnancy outcomes which could potentially jeopardise the entire program. However, during a pandemic, the balance between ‘benefit’ and ‘minimal harm’ might vary significantly when compared to a non‐pandemic situation 130 . For example, during the West African Ebola pandemic of 2013–2016, pregnant women faced a case fatality rate of 89%–93% 131 .…”