ABRYSVO (respiratory syncytial virus vaccine, pref a and b/pf)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Immunosuppression

There are 1 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Guillain-barre syndrome

There are 12 less severe adverse reactions.

More Frequent	Less Frequent
Fatigue Headache disorder Injection site pain Myalgia	Arthralgia Chills Diarrhea Extensive limb swelling after injection Injection site erythema Nausea

Rare/Very Rare
Syncope Vomiting

There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to RSV preF vaccine during pregnancy. Individuals who receive the vaccine during pregnancy are encouraged to contact, or have their healthcare provider contact 1-800-616-3791 to enroll in or obtain information about the registry. In a randomized controlled trial that enrolled pregnant individuals, preterm births were higher in those who received RSV preF vaccine at 24 through 36 weeks' gestation compared to those who received placebo; however, available data are insufficient to establish or exclude a causal relationship to the drug.

There was no evidence of a vaccine-associated increase in the risk of congenital anomalies or fetal deaths. To avoid the potential risk of preterm birth with use of RSV preF vaccine before 32 weeks of gestation, administer the vaccine as indicated in pregnant individuals at 32 through 36 weeks gestational age. RSV preF vaccine has not been studied in pregnant individuals <24 weeks gestational age, and those at increased risk for preterm birth. Results of a developmental toxicity study in animals showed no evidence of fetal harm or adverse effects on postnatal survival, growth, or development.

It is not known whether RSV preF vaccine is excreted in human milk. Data are not available to assess the effects of the vaccine on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the RSV preF vaccine and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition. For preventative vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

In the principal efficacy study of RSV preF vaccine in individuals 60 years of age and older, 63% of the participants were 60-69 years of age, 32% were 70-79 years of age, and 6% were >=80 years of age.