Arexvy Adjuvant Component (Pf)

Drug overview for AREXVY ADJUVANT COMPONENT (PF) (vaccine adjuvant system, as01e/pf, component vial 1 of 2):

Generic name: vaccine adjuvant system, AS01E/PF, component vial 1 of 2
Drug class:
Therapeutic class: Chemicals-Pharmaceutical Adjuvants

Respiratory syncytial virus (RSV) vaccine, adjuvanted is a protein subunit vaccine that stimulates active immunity to RSV infection; the vaccine is a recombinant stabilized pre-fusion F protein (RSVpreF3) antigen with an ASO1E adjuvant.

No enhanced Uses information available for this drug.

DRUG IMAGES

No Image Available

The following indications for AREXVY ADJUVANT COMPONENT (PF) (vaccine adjuvant system, as01e/pf, component vial 1 of 2) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following precautions are available for AREXVY ADJUVANT COMPONENT (PF) (vaccine adjuvant system, as01e/pf, component vial 1 of 2):

Pediatric
Pregnant
Lactation
Geriatric

RSV vaccine, adjuvanted is not approved for use in persons <50 years of age. Evidence from animal models strongly suggests that RSV vaccine, adjuvanted is unsafe in children <2 years of age because of an increased risk of enhanced respiratory disease. Safety and effectiveness of the vaccine in individuals 2 to 17 years of age have not been established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

RSV vaccine, adjuvanted is not approved for use in persons <50 years of age. In a randomized, controlled trial that enrolled pregnant individuals, preterm births were higher in those who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen as RSV, adjuvanted.

RSV vaccine, adjuvanted is not approved for use in persons <50 years of age. It is not known whether the vaccine is distributed into human milk; no human or animal data are available to assess vaccine effects 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 vaccination and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition (the susceptibility to disease prevented by the vaccine).

In the principal efficacy study, 55.8% of patients were 60-69 years of age, 36% were 70-79 years of age, and 8.2% were >=80 years of age.

Efficacy against RSV-related lower respiratory tract disease was 81% among participants 60 to 69 years of age and 93.8% among participants 70 to 79 years of age; insufficient cases were available to determine efficacy in patients >=80 years of age.