Overcoming Liability Concerns in Vaccine Trials Involving Pregnant Women

Without the protection of vaccines, the health of pregnant women may be compromised. But assessing the safety and efficacy of vaccines in pregnancy requires research in pregnancy. Furthermore, vaccinating women while they are pregnant may convey immunity to the fetus in utero, but assessing this possible benefit of maternal immunization also requires research. This article argues that one factor inhibiting vaccine research involving pregnant women is that vaccine manufacturers fear incurring liability if they fund such research. We argue that vaccine research in pregnancy can be ethical, and we explore some methods for overcoming vaccine manufacturers' fear of liability.