Ethically possible and ethically required: The path towards equitable inclusion of pregnant women in vaccine development

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Vaccination during pregnancy provides two important benefits [1–4]. First, it protects pregnant women against infection (by extension protecting the fetus and newborn against harm from maternal disease). Vaccination in pregnancy also provides neonates with protective antibodies before they are eligible for vaccination themselves.

Two routine vaccines, the influenza vaccine and the Tdap vaccine, are strongly recommended during pregnancy, and indeed have proved to be critical public health tools [5–8]. For example, maternal immunization with tetanus toxoid vaccine lowered global rates of infant death from tetanus by 93% [9] and the Tdap vaccine in pregnancy effectively prevents 80–91% of neonatal pertussis, an infection that increases infant risk of hospitalization and death [8].

Events of the past decade, including the 2009 H1N1 influenza pandemic and the 2016 Zika virus outbreak, have highlighted the disproportionate and devastating effects that infectious disease can have on pregnant women and their offspring. And yet, the health interests of pregnant women remain largely unaddressed in the development of vaccines, as is evidenced by the lack of inclusion of pregnant women (or women of reproductive potential not using effective forms of contraception) in past or current trials. This is a matter of critical concern because “pregnant women get sick and sick women get pregnant” [10].

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