Including Pregnant Women In Clinical Trials Could Be Key To Developing Effective Zika Vaccine
The Hill: To find an effective Zika vaccine, we must include pregnant women in the trials
Jae Jung, professor and chair of the Department of Molecular Microbiology and Immunology at the Keck School of Medicine at USC; and Suan-Sin Foo, postdoctoral scholar and research associate in the Department of Molecular Microbiology and Immunology at the Keck School of Medicine
“…The pursuit of a truly effective Zika virus vaccine … is handicapped by a long-standing clinical practice: the exclusion of pregnant women from drug development and vaccine trials. The main reason for this is ethical: Why expose a growing fetus, or a mother-to-be, to unknown risks in an experimental setting? … As commendable as this practice is, we argue it is more ethical to include pregnant women in certain clinical trials than to exclude them. … When contagions like Zika disproportionately affect pregnant women, excluding moms-to-be may end up harming them and their babies more than it helps. … To decide the most effective Zika virus vaccine based on tests among non-pregnant women with different body chemistry may produce a vaccine not potent enough for expectant mothers. … By contrast, the addition of expectant mothers as subjects in vaccine and drug-development trials holds out an intriguing and desirable possibility: a tailored therapy for different trimesters of pregnancy that caters specifically to the health and well-being of both mother and child” (11/12).