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HomeCDC RecommendationAbout RSVAbout ABRYSVO

About ABRYSVO

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The CDC recommends offering RSV vaccination year-round to eligible adults aged 60 years and older who remain unvaccinated, based on shared clinical decision-making1Check RSV off your vaccination list. For eligible patients who remain unvaccinated, offer an RSV vaccination year-round.National RSV Surveillance (NREVSS*)1,2Week ending: 3/23/24, Total PCR tests: 34,567

The CDC defines an RSV epidemic as weeks in which the percentage of PCR test results that were positive for RSV were ≥3%. The COVID-19 pandemic disrupted RSV seasonality during 2020-2022, but RSV may be returning to prepandemic seasonality.

RSV is highly contagious and can lead to serious consequences1Unlike influenza and COVID-19, there is no antiviral treatment for RSV2,3 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 these ranges.Based on a CDC study. Results were derived from RSV-NET data from the 2022-2023 RSV season, in adults aged 65 years and older.

RSV has only 2 subgroups (RSV-A and RSV-B) that circulate each season.2
During the 2023-2024 RSV season, over 2/3 of the RSV circulating in the U.S. was subgroup B.6-8‡

ABRYSVO is a bivalent vaccine, containing equal proportions of RSV-preF A and RSV-preF B as the antigens.9

‡Results seen in 3 genomic sequencing studies in the 2023-2024 season.6-8

ReferencesNREVSS is a surveillance system in which participating US 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; NREVSS=National Respiratory and Enteric Virus Surveillance System; PCR=polymerase chain reaction; preF=prefusion F; RSV=respiratory syncytial virus.References
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References:Carvajal JJ, Avellaneda AM, Salazar-Ardiles C, Maya JE, Kalergis AM, Lay MK. Host components contributing to respiratory syncytial virus pathogenesis. Front Immunol. 2019;10:2152.Talbot HK, Belongia EA, Walsh EE, Schaffner W. Respiratory syncytial virus in older adults: a hidden annual epidemic. Infect Dis Clin Pract. 2016;24(6):295-302.PAXLOVID Prescribing Information. Pfizer Inc; 2023.Havers F. Epidemiology and burden of respiratory syncytial virus in older adults in the US. Published June 23, 2022. Centers for Disease Control and Prevention. Accessed June 11, 2024. https://stacks.cdc.gov/view/cdc/118594Centers for Disease Control and Prevention. Surveillance of RSV. Updated June 5, 2024. Accessed July 17, 2024. https://www.cdc.gov/rsv/php/surveillance/index.htmlYunker M, Fall A, Norton J, et al. Genomic evolution and surveillance of respiratory syncytial virus during the 2023–2024 season. Viruses. 2024;16(7):1122.Mostafa H, Fall A, Norton J, et al. Respiratory virus disease and outcomes at a large academic medical center in the United States: a retrospective observational study of the early 2023/2024 respiratory viral season. Microbiol Spectr. 2024;12(10):e0111624.Surie D, Self W, Zhu Y, et al. RSV vaccine effectiveness against hospitalization among US adults 60 years and older. JAMA. 2024;332(13):1105-1107.ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; January 2025. Centers for Disease Control and Prevention. Interactive dashboard. Updated December 3, 2024. Accessed December 12, 2024. https://www.cdc.gov/nrevss/php/dashboard/index.htmlHamid S, Winn A, Parikh R, et al. Seasonality of respiratory syncytial virus—United States, 2017-2023. MMWR Morb Mortal Wkly Rep. 2023;72(14):355-361.Centers 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 10, 2024. Accessed December 12, 2024. https://www.cdc.gov/rsvvaxview/dashboard/adults-60-coverage-intent.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 20, 2024. Accessed June 25, 2024. https://data.cdc.gov/Laboratory-Surveillance/Percent-Positivity-of-Respiratory-Syncytial-Virus-/3cxc-4k8q/about_dataCenters for Disease Control and Prevention. Respiratory virus activity levels. Updated October 25, 2024. Accessed October 25, 2024. 
https://cdc.gov/respiratory-viruses/data/activity-levels.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 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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