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HomeCDC RecommendationAbout RSVAbout ABRYSVO

About ABRYSVO

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Prescribing InformationIndicationsPatient SiteMaternal
Health Plan CoverageCoverage Changes Under the Inflation Reduction Act (IRA): Eliminated cost-sharing in Medicare Part D for people enrolled in Part D
  • ABRYSVO® may be made available by certain insurance plans at no cost in accordance with the Inflation Reduction Act
  • Please see if ABRYSVO is covered under your patient's insurance plan. Additional savings and support options may be available at Pfizer RxPathways®
  • Certain vaccines may be covered or available at lower out-of-pocket costs in Medicare Part D, Medicaid, the Children’s Health Insurance Program, or other consumer plans through the Inflation Reduction Act. Coverage may vary based on the vaccine and the insurance plan. For more information, visit cms.gov
Age 60-64

For patients 60 years and older who have commercial insurance, it is expected ABRYSVO will be covered by the medical benefit of health plans and billed like any other vaccine in the office.

Age 65+

For patients 65 years and older who have Medicare benefits, ABRYSVO will be covered as a Part D benefit. For these patients, you can verify benefits and adjudicate claims for ABRYSVO through a billing platform, or by referring the patient to a local pharmacy with an e-prescription.

If you have questions about patient eligibility, reimbursement, or claims submissions, contact the Pfizer Vaccines Reimbursement Support Services at 1-866-744-3198.

 Billing and Coding Info View Guide ReferencesPayer policies are complex and change frequently. Please consult with the individual payer or PBM for the latest information to confirm coverage.ACA=Affordable care Act; ACIP=Advisory Committee on Immunization Practices; PBM=pharmaceutical benefits manager.
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IndicationsABRYSVO is a vaccine indicated for:
  • active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older
  • active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age
  • active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV
Please click here for full Prescribing Information.
Important Safety Information
  • Do not administer ABRYSVO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of ABRYSVO
  • The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with ABRYSVO
  • A numerical imbalance in preterm births was observed compared to placebo in 2 clinical studies. Data are insufficient to establish or exclude a causal relationship between preterm birth and ABRYSVO. To avoid potential risk of preterm birth with use of ABRYSVO before 32 weeks of gestation, administer to pregnant individuals at 32 through 36 weeks gestational age
  • Appropriate medical treatment must be available in case of an anaphylactic reaction
  • Syncope (fainting) may occur in association with administration of injectable vaccines, including ABRYSVO. Procedures should be in place to avoid injury from fainting
  • Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to ABRYSVO
  • Vaccination with ABRYSVO may not protect all vaccine recipients
  • In clinical trials with adults aged 60+, the most commonly reported (≥10%) adverse reactions
were fatigue (15.7%), headache (12.9%), pain at the injection site (10.7%), and muscle pain (10.2%)
  • In clinical trials with adults aged 18-59, the most commonly reported (≥10%) adverse reactions were pain at the injection site (35.3%), muscle pain (24.4%), joint pain (12.4%), and nausea (11.8%)
  • In clinical trials with pregnant individuals, the most commonly reported (≥10%) adverse reactions
were pain at the injection site (40.6%), headache (31.0%), muscle pain (26.5%), and nausea (20.0%)
  • In clinical trials with infants born to pregnant individuals, low birth weight (5.1% ABRYSVO versus 4.4% placebo) and neonatal jaundice (7.2% ABRYSVO versus 6.7% placebo) were observed
Individuals who received ABRYSVO during pregnancy are encouraged to contact 1-800-616-3791 to enroll in a Pregnancy Exposure Registry.

Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please see full Prescribing Information for ABRYSVO.IndicationsABRYSVO is a vaccine indicated for:
  • active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older
     
  • active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age
     
  • active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV
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