Cholera vaccine, live Pregnancy and Breastfeeding Warnings

Brand names: Vaxchora

Medically reviewed by Drugs.com. Last updated on Dec 11, 2023.

Cholera vaccine, live Pregnancy Warnings

According to some authorities: This vaccine should be administered during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: This drug is not systemically absorbed following oral administration; therefore, maternal use of this vaccine is not expected to result in fetal exposure.

Comments:
-There are limited data on the use of this vaccine in pregnant women.
-The vaccine strain may be shed in the stool for at least 7 days following oral vaccination; there is a potential risk of transmission of the vaccine strain from the pregnant individual to the newborn during vaginal delivery.

Animal studies are unavailable. There are no controlled data in human pregnancy.

Maternal cholera disease is associated with adverse pregnancy outcomes including fetal death.

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

Cholera vaccine, live Breastfeeding Warnings

This drug has been used without apparent harmful effects.
-According to some authorities: A risk to the breastfed cannot be excluded; therefore, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and benefit of breastfeeding for the child.

Excreted into human milk: No

Comments:
-This vaccination is not systemically absorbed after oral administration.
-Breastfeeding is not expected to result in exposure of this vaccine to the breastfed child.
-In a clinical study, breastfed infants 10 to 18 months of age who did not breastfeed within 3 hours of administering the vaccine had a higher antibody immune response compared to patients 6 to 9 months of age.

See references

Further information

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