Chikungunya vaccine, recombinant (cvx 329) Pregnancy and Breastfeeding Warnings

Brand names: Vimkunya

Medically reviewed by Drugs.com. Last updated on Apr 1, 2025.

Chikungunya vaccine, recombinant (cvx 329) Pregnancy Warnings

Safety has not been established.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.

Animal studies have failed to reveal evidence of embryofetal toxicity. Administration of a single human dose of this vaccine to female animals on 5 separate occasions (i.e., twice prior to mating, twice during gestation, and once during lactation) did not demonstrate adverse effects on fetal or postnatal development. However, postnatal survival was reduced in some cases. There are no controlled data in human pregnancy.

Transmission of wild-type chikungunya virus to neonates from pregnant women with viremia at delivery is common and can cause severe, potentially fatal chikungunya disease in neonates, with neurologic (e.g., encephalopathy, intracranial hemorrhage) and myocardial manifestations.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients, and pregnant women are encouraged to register themselves by calling 1-888-230-2491 or visiting bnpregnancyregistry.com.

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

Chikungunya vaccine, recombinant (cvx 329) Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-This vaccine does not contain live organisms; the use of non-live vaccines is generally considered acceptable during breastfeeding according to the US CDC and other experts.
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-The effects in the nursing infant are unknown; however, there is no evidence that recombinant vaccines would harm a nursing infant.
-Providers should consider the benefits of breastfeeding, the lactating individual's need for the use of the vaccination and/or susceptibility to disease, and the risk of adverse effects on the breastfed child.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer