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ABRYSVO® was evaluated in adults aged 60+ in a real-world evidence (RWE) study1
Scroll below to see the study description and results
Study Description1
ABRYSVO vaccine effectiveness (VE) against RSV-associated lower respiratory tract disease (LRTD) hospitalizations or ED visits was assessed among adults aged 60 years and older (n=5,714) within a retrospective, case-control study with a test-negative design. The study was conducted with Kaiser Permanente Southern California from November 2023 through April 2024. Patients hospitalized or admitted to the ED with LRTD were tested for RSV, and categorized as cases if they tested positive, or controls if they tested negative. Participants were considered vaccinated if they received ABRYSVO at least 21 days prior to the LRTD event. Of those enrolled:
60% were aged 75 years or older
95% had ≥1 comorbidity
15% were immunocompromised
For full study design details, please refer to the study link belowVaccine effectiveness against RSV-LRTD hospitalizations and ED visits was observed among patients vaccinated with ABRYSVO1In addition to the VE assessed in the primary analysis, VE was also assessed in high-risk patients and those with severe RSV outcomes.Study LimitationsBefore viewing the full study, please review the following limitations and considerations:
Fewer than 5% of those with LRTD events were vaccinated in the first season, potentially impacting generalizability of estimates and preventing stable vaccine effectiveness estimates for some subgroups
Not all LRTD events in the ED or hospital setting were tested for RSV
Conducted in Southern California; study results may not be generalizable to entire population
These early first-season estimates miss the first part of RSV season, resulting in lower median follow-up times
Certain VE estimates include wide confidence intervals, due to small sample size. Study will continue to accrue cases to power future analyses
Read the RWE study LoadingAnalysis was completed using strict controls: RSV-negative LRTD events that were negative for human metapneumovirus, SARS-CoV-2, and influenza; and positive for a nonvaccine preventable cause.1Severe hospitalization defined as needing oxygen supplementation.1Including asthma; chronic obstructive pulmonary disease; congestive heart failure; coronary artery disease; other chronic lung, cardiac, kidney, or liver diseases; diabetes; neurological conditions; stroke; autoimmune disorders; immunocompromising conditions and medications; HIV; AIDS; cancers; organ transplant; and blood disorders.1AIDS=acquired immunodeficiency syndrome; CI=confidence interval; ED=emergency department; HIV=human immunodeficiency virus; RSV=respiratory syncytial virus; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.Related ContentRelated ContentRelated ContentOrder ABRYSVOLoadingRefer ABRYSVOLoading
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References:Tartof SY, Aliabadi N, Goodwin G, et al. Estimated vaccine effectiveness for respiratory syncytial virus–related lower respiratory tract disease. JAMA Netw Open. 2024;7(12):e2450832.Camm AJ, Fox KAA. Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants. Open Heart. 2018;5(1):e000788.Chen D. Real-world studies: bridging the gap between trial-assessed efficacy and routine care. J Biomed Res. 2022;36(3):147-154.Kabisch M, Ruckes C, Seibert-Grafe M, Blettner M. Randomized controlled trials: part 17 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2011;108(39):663-668.Khosla S, White R, Medina J, et al. Real world evidence (RWE) - a disruptive innovation or the quiet evolution of medical evidence generation? F1000Res. 2018;7:111.Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. Pharmacoepidemiol Drug Saf. 2017;26(9):1033-1039.Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health. 2007;10(5):326-335.Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763-1774.
This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.
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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