Benefit should outweigh risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-An observational study of one formulation of this vaccine administered during the third trimester and post-marketing surveillance have not detected an increase or any unusual patterns of adverse events.
-According to some authorities, the inactivated polio antigens are not expected to harm the fetus.
-Many formulations are not approved for adult use; the manufacturer product information should be consulted.

Animal studies of intramuscular administration twice before matting and several times during gestation (and once in lactation in one animal model) with doses lower than the human dose showed no embryofetal developmental effects (or postnatal developmental effects). There are no controlled data in human pregnancy. An observational study of one formulation of this vaccine administered during the third trimester and post-marketing surveillance have not detected an increase or any unusual patterns of adverse events. Human data on used in the first or second trimester are not available. Limited data indicate that maternal antibodies from vaccination during pregnancy may decrease the magnitude of infant immune response to some vaccines; the clinical relevance of this is unknown. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.

See references

Safety has not been established; benefit should outweigh risk.

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

Comments:
-Animal studies of administration during pregnancy showed higher serum titers in pups on lactation day 25 than lactation day 4, suggesting maternal antibody transfer during lactation.
-According to some authorities, because this vaccine contains toxoids or inactivated antigens adverse effects are not expected in the infant.
-Many formulations are not approved for adult use; the manufacturer product information should be consulted.

See references