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 Pneumococcal Polysaccharide Conjugate Vaccine, 15-Valent (Adsorbed) (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 Pneumococcal Polysaccharide Conjugate Vaccine, 15-Valent (Adsorbed) (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 Pneumococcal Polysaccharide Conjugate Vaccine, 15-Valent (Adsorbed) (VAXNEUVANCE) in pregnant women, and human data available from clinical trials with Pneumococcal Polysaccharide Conjugate Vaccine, 15-Valent (Adsorbed) (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; Pneumococcal Polysaccharide Conjugate Vaccine, 15-Valent (Adsorbed) (VAXNEUVANCE) should be administered only if clearly needed.
Nursing Mothers: It is not known whether this vaccine is excreted in human milk.