Smallpox and monkeypox vaccine Pregnancy and Breastfeeding Warnings

Brand names: Jynneos

Medically reviewed by Drugs.com. Last updated on Aug 16, 2022.

Smallpox and monkeypox vaccine Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No data on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-There is insufficient data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

Various studies in rats and rabbits receiving a single human dose of this drug by the subcutaneous route on two or three occasions (prior to mating, and during gestation) showed no related embryo-fetal or postnatal development and no adverse effects in female fertility or pre-weaning development. There are no controlled data in human pregnancy.

In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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.

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Smallpox and monkeypox vaccine Breastfeeding Warnings

Use is not recommended.

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

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.
-According to some authorities, nursing mothers should not receive this drug, even if they are pumping their milk and feeding it to the infant by bottle. Breastfeeding should be avoided, as well as handling any baby for at least 3 to 4 weeks until the vaccination scab has separated from the vaccination site. The breast can be pumped but milk should be discarded. Live virus can be inadvertently passed from the lactating mother to the infant, and there can be high risk of developing serious complications.

See references

Further information

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

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