Shingrix vaccine Pregnancy Warnings
Animal studies showed no adverse effects on fetal or pre-weaning development when administered prior to mating, during gestation, and during lactation, and no vaccine related fetal malformations or variations. There are no controlled data in human pregnancy. 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%.
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.
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.
The manufacturer makes no recommendation regarding use during pregnancy.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned
Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
See references
Shingrix vaccine Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Data are not available to assess the effects of this drug on the infant or on milk production.
-The development and health benefits of breastfeeding should be considered as well as any potential adverse effects on the infant.
Animal studies showed no adverse effects on fetal or pre-weaning development when administered prior to mating, during gestation, and during lactation.
See references
