Pneumococcal 15-valent conjugate vaccine Pregnancy and Breastfeeding Warnings

Brand names: Vaxneuvance

Medically reviewed by Drugs.com. Last updated on Oct 2, 2023.

Pneumococcal 15-valent conjugate vaccine Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk summary: Available data on use of this drug in pregnant women are insufficient to inform a drug-related risk.

Comments:
-There are inadequate data available on the use of this drug in pregnant women to inform of a drug-related risk.
-Animal-related studies of the administration of human doses did not reveal evidence of fetal harm.

Animal studies have failed to reveal evidence of embryolethality, embryofetal toxicity, and adverse effects on parturition or postnatal development). Animal studies of a dose equivalent to approximately 200 times the adult human dose (mcg/kg) and given via IM injection on 4 occasions (twice before mating, once during gestation, and once during lactation) showed no evidence of developmental harm to the fetus. There are no controlled data on human pregnancy. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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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Pneumococcal 15-valent conjugate vaccine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on its presence in human milk, its effects on a breastfed infant, or its 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.

See references

Further information

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