Prevnar 13 Pregnancy Warnings
Safety has not been established during pregnancy; use during pregnancy only if clearly needed.
AU TGA pregnancy category: B2
US FDA pregnancy category: B
Animal studies showed no fetal harm or impairment of fertility; antibodies against vaccine serotypes were detected in the fetuses and pups. There are no controlled data in human pregnancy.
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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
