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HomeCDC RecommendationAbout RSVAbout ABRYSVO

About ABRYSVO

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Prescribing InformationIndicationsPatient SiteMaternal
Patient ProfilesABRYSVO®: CDC-recommended for all adults aged 75 and older and for adults aged 60-74 years who are at increased risk of severe RSV disease1,2The risk to your vulnerable patients from RSV is real: Protect them with ABRYSVO this RSV seasonTake every opportunity to protect more of your eligible patients today Risk Conditions LoadingReferencesRisk versus patients the same age with no comorbidities. Risk calculation (RSV-associated hospitalization rate per 100,000) results come from CDC studies based on community-dwelling adults with and without chronic medical conditions, stratified by age group (50-64, 65-74, ≥75 years).3,5 Data from RSVVaxView, as of December 28, 2024.4CDC=Centers for Disease Control and Prevention; COPD=chronic obstructive pulmonary disease; CVD=cardiovascular disease; RSV=respiratory syncytial virus.Related ContentRelated ContentRelated ContentOrder ABRYSVOLoadingVaccine LocatorLoading

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Explore a range of resources related to ABRYSVO, including videos, information about upcoming events, and more.

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References:Centers for Disease Control and Prevention. CDC updates RSV vaccination recommendation for adults. June 26, 2024. Accessed July 3, 2024. 
https://www.cdc.gov/media/releases/2024/s-0626-vaccination-adults.htmlBritton A, Roper LE, Kotton CN, et al. Use of respiratory syncytial virus vaccines in adults aged ≥60 years: updated recommendations of the Advisory Committee on Immunization Practices - United States, 2024. MMWR Morb Mortal Wkly Rep. 2024;73(32):696-702.Woodruff R. Chronic conditions as risk factors for RSV-associated hospitalization. Centers for Disease Control and Prevention. Accessed June 17, 2024. 
 https://www.cdc.gov/acip/downloads/slides-2024-02-28-29/03-rsv-adults-woodruff-508.pdfCenters for Disease Control and Prevention. Respiratory syncytial virus (RSV) vaccination coverage and intent for vaccination, adults 75 years and older and adults 60–74 years with high-risk conditions, United States. December 3, 2024. Accessed December 11, 2024. https://www.cdc.gov/rsvvaxview/dashboard/index.htmlBritton A, Melgar M, Roper L. Evidence to recommendations framework (EtR): RSV vaccination in adults aged 50-59 years, 60-74 years, and 75 years and older. Centers for Disease Control and Prevention. June 26, 2024. Accessed December 11, 2024. https://stacks.cdc.gov/view/cdc/157857Havers FP, Whitaker M, Melgar M, et al. Burden of respiratory syncytial virus–associated hospitalizations in US adults, October 2016 to September 2023. JAMA Network Open. 2024;7(11):e2444756. doi:10.1001/jamanetworkopen.2024.44756

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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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