Arexvy Use In Pregnancy & Lactation

Pregnancy: There are no data from the use of Arexvy in pregnant women. After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3,557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo. Currently no conclusion on a causal relationship between administration of unadjuvanted RSVPreF3 and preterm birth can be drawn. Results from animal studies with an investigational unadjuvanted RSVPreF3 vaccine and results with Arexvy do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Arexvy is not recommended during pregnancy.
Breast-feeding: There are no data on the excretion of Arexvy in human or animal milk. Arexvy is not recommended in breast-feeding/lactating women.
Fertility: There are no data on the effects of Arexvy on human fertility. Animal studies with an investigational unadjuvanted RSVPreF3 vaccine or Arexvy do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).