Zika is a disease whose burden falls most heavily on pregnant women. In most people who come down with it, the virus is symptomless, and passes through the body with the person none the wiser. When symptoms do bloom, they are unpleasant, but not particularly dangerous to most. If someone who’s pregnant gets Zika, however, the consequences for the fetus can be devastating. The virus causes underdevelopment of the head and brain, known as microcephaly, and a hodgepodge of other symptoms, like eye damage and clubfoot, which are loosely categorized as Congenital Zika Syndrome.
For this reason, a working group made up of bioethicists, OB/GYNs, vaccinologists and others recently released ethics guidelines for Zika vaccine development, in which they recommend that pregnant women should be included in clinical trials for Zika vaccines.
Pregnant women are very rarely included in medical research. They are seen as too complicated, given all the physiological changes of pregnancy, and too risky; researchers and companies that sponsor research may be worried about possible harm to the fetus, and the legal liability that could follow. The Department of Health and Human Services’ regulations classify pregnant women as a “vulnerable population” that needs special protection when participating in research. This doesn’t mean they can’t be included—the regulations lay out 10 conditions that must be met when enrolling pregnant women in a research study. A 1994 Institute of Medicine report also recommended that pregnant women should be considered eligible for studies, and only be excluded if there is no benefit to them or if there’s a clear danger to the fetus. But they tend to still be excluded from most research anyway.