Dengvaxia Use In Pregnancy & Lactation

Pregnancy: Pregnancy constitutes a contraindication (see Contraindications).
Women of childbearing age should avoid becoming pregnant for 4 weeks after receiving any dose of Dengvaxia.
No specific studies have been performed on the vaccine in pregnant women. A limited number of cases of inadvertent exposure during pregnancy were reported during clinical studies. Isolated adverse pregnancy outcomes (stillbirth, intrauterine death, spontaneous abortion, blighted ovum) have been observed for these exposed pregnancies, with similar frequency and nature in the vaccinated individuals compared to the control group, and with risk factors identified for all cases. However, these data are not sufficient to conclude on the absence of potential effects of Dengvaxia on pregnancy, embryo-fetal development, parturition and post-natal development.
Animal studies did not indicate any direct or indirect harmful effects with regard to pregnancy, embryo-fetal development, parturition or post-natal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breastfeeding: Dengvaxia is contraindicated during breastfeeding (see Contraindications).
It is not known whether Dengvaxia is excreted into human milk. The effect on breastfed infants of administration of Dengvaxia to their mothers has not been studied.
Animal studies did not indicate any direct or indirect harmful effects with regard to lactation (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fertility: No specific studies have been performed on fertility.
Animal studies did not indicate any harmful effects with respect to female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).