New adjuvanted vaccines in pregnancy: what is known about their safety?

The recent introduction of oil-in-water emulsions as adjuvants in several pandemic vaccines, such as the H1N1 vaccine, has challenged regulatory authorities to establish their safety in the general population, as well as in specific populations. Pregnant women were advised to be a target group for H1N1 vaccination owing to the risk of this group developing serious complications with this infection. However, the addition of adjuvants to the H1N1 vaccine has initiated a discussion on the safety of adjuvanted vaccines in this special population. Changes in the maternal immune system are essential for acceptance of the fetus and for development of the placenta. The potential effects on pregnancy of interfering with this uniquely adapted immune balance through the induction of proinflammatory reactions such as those induced by adjuvanted vaccines have only been studied rarely. Here, we review the available information and discuss how vaccination may interfere with pregnancy, fetal development and pregnancy outcomes.