Chikungunya vaccine, live (cvx 317) Pregnancy and Breastfeeding Warnings

Brand names: Ixchiq

Medically reviewed by Drugs.com. Last updated on Feb 18, 2024.

Chikungunya vaccine, live (cvx 317) Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned.

Risk summary: There are insufficient data available on the use of this drug in pregnancy to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Close monitoring of the newborn for the vaccine virus should be conducted for 7 days after birth if the neonate was born within 14 days of their mother receiving this vaccine.
-Vaccine viremia occurs after vaccination, with viremia resolution occurring 14 days after vaccination.

Animal studies have failed to reveal evidence of adverse effects on female fertility, fetal harm, neonatal harm, fetal adverse effects, and neonatal adverse effects when given a single human dose, both before mating and during gestation. There are no controlled data in human pregnancy. Vertical, wild-type virus transmission has resulted in severe, potentially fatal chikungunya virus (CHIKV) disease in neonates, and fetal death attributable to antepartum CHIKV has infrequently been reported.

To monitor the outcomes of pregnant women exposed to this drug during conception or pregnancy, an IXCHIQ pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling OXON Epidemiology at 1-855-417-6214 or visiting www.valneva-oxon.com/IXCHIQPregnancyRegistry

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 healthcare 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

Chikungunya vaccine, live (cvx 317) Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects on milk production and in the nursing infant are unknown.
-Vaccine viremia occurs after vaccination.
-Vaccine virus was not detectable 14 days after vaccination in a clinical trial.
-Providers should consider the benefits of breastfeeding, the lactating individual's need for the use of the vaccination, and the risk of adverse effects on the breastfed child.

See references

Further information

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