Dengue vaccine Pregnancy and Breastfeeding Warnings

Brand names: Dengvaxia

Medically reviewed by Drugs.com. Last updated on Jul 25, 2023.

Dengue vaccine Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: Pregnant women with dengue may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. Vertical transmission of dengue virus from mothers with viremia at delivery to their infants has been reported.

Comments:
-There is no sufficient data on the use of this vaccine in pregnant women, and its effect on embryo-fetal development, parturition, and postnatal development. A limited number of inadvertent exposures during pregnancy were reported during clinical studies and showed isolated adverse pregnancy outcomes (e.g., stillbirth, intrauterine death, spontaneous abortion, blighted ovum), with similar frequency and nature in the vaccinated individuals compared to the control group.
-A pregnancy exposure registry is available.

The effect of this vaccine was evaluated in 2 developmental studies in pregnant rabbits and mice. Female rabbits received a full human dose by intravenous injection prior to mating and during gestation (days 6, 12 and 27). There was no evidence of harm to the fetus, effects on female fertility or postnatal development due to the vaccine. Additionally, female mice were administered a single dose (either a full human dose, a dose about 3 times the maximum recommended human dose (3 x MRHD) or about 100 x MRHD) of the vaccine by IV injection during gestation (day 6, 9 and 12). Maternal toxicity was observed with increased post implantation loss at 3 x MRHD and reduced fetal body weight at 100 x MRHD. There are no controlled data in human pregnancy, and the significance of these animal observations for humans is unknown, especially considering the different route of administration (the human route of administration is subcutaneous) and dose levels which exceeded the intended human dose.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed during pregnancy. Exposed women or their healthcare professional can contact, Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE) to enroll in or obtain information about the registry.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Dengue vaccine Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Data not available
Excreted into animal milk: No

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

A lactation study in which female mice received a single dose of this vaccine on day 14 of lactation did not show the presence of the drug in breast milk. Vertical transmission of dengue virus, including potentially through breastmilk, has been reported.

See references

Further information

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