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HomeCDC RecommendationAbout RSVAbout ABRYSVO

About ABRYSVO

Efficacy ProfileImmunobridgingSafety ProfilePatient ProfilesDosing, Storage, & ReconstitutionEfficacy & Real-World EvidenceEfficacy &
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Prescribing InformationIndicationsPatient SiteMaternal
National RSV Surveillance (NREVSS*)1,2Week ending: 3/23/24, Total PCR tests: 34,567RSV can set your patients' health back1,2An estimated 110,000-180,000 adults aged 50+ are hospitalized each year due to RSV3*
Unlike influenza, RSV has no approved antiviral treatment5
Data estimates from the 2016 through 2023 RSV seasons. Rates of RSV-associated hospitalizations in RSV-NET were adjusted for underdetection due to testing practices. Given atypical RSV circulation, the 2020-2021 and 2021-2022 seasons were excluded from this range. RSV vaccines first became available during the 2023-2024 RSV season.3In a study of 645 hospitalized patients aged 60+ with RSV and 1,878 hospitalized patients aged 60+ with influenza, patients with RSV were more likely to have hospital stays that exceeded 7 days (P<0.001), develop pneumonia (P<0.001), and be admitted to the ICU (P=0.023).4The number of at-risk patients in your practice may be higher than you think Represents all U.S. adults aged 75+ and adults aged 50-74 with certain underlying medical conditions.2,6-8 As of February 2026. This is based on information licensed from IQVIA: Projected claims data for the period from August 2023-February 2026, reflecting estimates of real-world activity. All rights reserved.8ReferencesNREVSS is a surveillance system in which participating U.S. laboratories voluntarily report weekly to the CDC the total number of tests and positive test results.CDC=Centers for Disease Control and Prevention; HHS=U.S. Department of Health and Human Services; ICU=intensive care unit; NREVSS=National Respiratory and Enteric Virus Surveillance System; PCR=polymerase chain reaction; RSV=respiratory syncytial virus; RSV-NET=Respiratory Syncytial Virus Hospitalization Surveillance Network.References
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References:DeMartino JK, Lafeuille M-H, Emond B, et al. Respiratory syncytial virus–related complications and healthcare costs among a Medicare-insured population in the United States. Open Forum Infect Dis. 2023;10(5):ofad203.Centers for Disease Control and Prevention. RSV vaccine guidance for adults. Updated February 24, 2026. Accessed June 15, 2026. https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/adults.htmlHavers FP, Whitaker M, Melgar M, et al. Burden of respiratory syncytial virus–associated hospitalizations in US adults, October 2016 to September 2023. JAMA Netw Open. 
2024;7(11):e 2444756.Ackerson B, Tseng HF, Sy LS, et al. Severe morbidity and mortality associated with respiratory syncytial virus versus influenza infection in hospitalized older adults. Clin Infect Dis. 2019;69(2):197-203.Trifonov G, Büscher E, Fistera D, et al. Disease burden of RSV infection in adult patients in comparison to influenza virus infection. J Med Virol. 2025;97(5):e70373.Britton A, Melgar M, Surie D. Evidence to recommendations framework (EtR): RSV vaccination in adults aged 50-59 years. Centers for Disease Control and Prevention. Published April 16, 2025. Accessed June 15, 2026. https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/06-Melgar-Surie-adult-rsv-508.pdfU.S. Census Bureau. Annual estimates of the resident population for selected age groups by sex for the United States: April 1, 2020 to July 1, 2024. Release date: June 2025. Accessed June 15, 2026. https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html#v2025Data on file. Pfizer Inc.Centers for Disease Control and Prevention. RSV-NET interactive dashboard. Updated June 18, 2025. Accessed June 15, 2026. https://www.cdc.gov/nrevss/php/dashboard/index.htmlCenters for Disease Control and Prevention. Percent positivity of respiratory syncytial virus nucleic acid amplification tests by HHS region, National Respiratory and Enteric Virus Surveillance System. Updated June 11, 2026. Accessed June 15, 2026. https://data.cdc.gov/Laboratory-Surveillance/Percent-Positivity-of-Respiratory-Syncytial-Virus-/3cxc-4k8q/about_dataCenters for Disease Control and Prevention. Respiratory syncytial virus (RSV) vaccination coverage and intent for vaccination, adults 75 years and older and adults 50-74 years with high-risk conditions, United States. Updated March 11, 2026. Accessed June 15, 2026. https://www.cdc.gov/rsvvaxview/dashboard/adults-50-coverage-intent.htmlMelgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801.

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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 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 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 (10.6%), 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 vs 4.3% placebo) and neonatal jaundice (7.3% ABRYSVO vs 6.9% 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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