Meningococcal group acwy conjugate-group b vaccine (cvx 328) Pregnancy and Breastfeeding Warnings

Brand names: Penmenvy

Medically reviewed by Drugs.com. Last updated on Jul 16, 2025.

Meningococcal group acwy conjugate-group b vaccine (cvx 328) Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

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

Animal studies have failed to reveal evidence of adverse effects on female fertility, fetal harm, or postnatal harm. Animal studies using 0.5 mL single human doses of this vaccine given on 5 occasions (3 times prior to mating and twice during gestation) showed no evidence of vaccine-related female fertility effects or developmental harm to the fetus. There are no controlled data in human pregnancy.

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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Meningococcal group acwy conjugate-group b vaccine (cvx 328) Breastfeeding Warnings

Safety has not been established.

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 of this drug on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-The US CDC and other professional health organizations state that vaccination does not affect the safety of breastfeeding, and that breastfeeding is not a contradiction to meningococcal vaccine.

See references

Further information

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