Animal studies are unavailable. There are no controlled data in human pregnancy. Maternal cholera disease is associated with adverse pregnancy outcomes including fetal death.

There is a registry that monitors pregnancy outcomes in women exposed to this vaccine during pregnancy. To enroll in or obtain information about the registry, please call PaxVax at 1-800-533-5899.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-This vaccine is not absorbed systemically, and maternal use is not expected to expose the fetus.
-The vaccine strain may be shed in the stool for at least 7 days, with potential transmission from the mother to infant during vaginal delivery.

See references

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-This vaccine is not absorbed systemically, and breastfeeding is not expected to expose the child to the vaccine.

See references