Abrysvo Use In Pregnancy & Lactation

Pregnancy: Data on pregnant women (more than 4,000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity.
Results from animal studies with Abrysvo do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
In a phase 3 study (Study 1), maternal adverse events reported within 1 month after vaccination were similar in the Abrysvo group (14%) and the placebo group (13%).
No safety signals were detected in infants up to 24 months of age. The incidences of adverse events reported within 1 month after birth in infants were similar in the Abrysvo group (37%) and the placebo group (35%). Major birth outcomes assessed in the Abrysvo group compared to placebo included premature birth (201 (6%) and 169 (5%), respectively), low birth weight (181 (5%) and 155 (4%), respectively) and congenital anomalies (174 (5%) and 203 (6%), respectively).
Breast-feeding: It is unknown whether Abrysvo is excreted in human milk. No adverse effects of Abrysvo have been shown in breastfed newborns of vaccinated mothers.
Fertility: No human data on the effect of Abrysvo on fertility are available.
Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).