Vaxneuvance Use In Pregnancy & Lactation

Pregnancy: Animal Data: Developmental and reproductive toxicity studies have been performed in female rats at a dose approximately 200 times the adult human dose on a mcg/kg basis. In these studies, female rats received VAXNEUVANCE (32 mcg/rat/dose) by intramuscular injection 28 days and 7 days prior to mating, on gestation day 6 and on lactation day 7. There was no evidence of embryofetal lethality or fetal malformations and variations and no adverse effects on pre-weaning development were observed. Antibodies to all 15 serotypes contained in VAXNEUVANCE were detected in offspring, attributable to the acquisition of maternal antibodies via placental transfer during gestation and possibly via lactation.
Human Data: There are no adequate and well-controlled studies of VAXNEUVANCE in pregnant women, and human data available from clinical trials with VAXNEUVANCE have not established the presence or absence of vaccine-associated risk during pregnancy. The decision to vaccinate a woman who is pregnant should consider the woman’s risk of pneumococcal disease; VAXNEUVANCE should be administered only if clearly needed.
Nursing Mothers: It is not known whether this vaccine is excreted in human milk.