No abstract

The rubella virus is a potent human teratogen. Because the rubella vaccine is prepared with live virus, a high level of anxiety surrounds exposure in pregnancy. There is relatively scarce data on fetal risk following vaccination in pregnancy, and all of the available data were collected retrospectively. Our objective was to examine whether periconceptional exposure to rubella vaccine can cause the congenital rubella syndrome, and to compare the rate of major malformations and developmental milestones among offspring of women who received rubella vaccine 3 months pre- or post-conception to an unexposed comparison group. We collected prospectively and followed up 94 women who received rubella vaccination 3 months pre- or post-conception and a comparison group that consisted of 94 women who were counseled during pregnancy in a similar manner but were not exposed to known teratogens. The controls were matched for age, smoking, alcohol, and drug use. Not any of the women exposed to the vaccine gave birth to a child with congenital rubella syndrome. Rates of major malformations were similar in both groups as were birth weights and developmental milestones. In contrast, the rate of therapeutic abortions was higher in the exposed group (7.4% vs. 0%) (P < 0.05), due to fears of teratogenicity. We conclude that rubella vaccination in pregnancy does not appear to affect pregnancy outcome in general or cause congenital rubella syndrome in particular.

Drugs that can kill a toddler with 1-2 dose units should be known to clinicians as such exposures warrant immediate and intensive management. A new system of special labeling of these drugs should be considered.