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Review select real-world evidence (RWE) studies of ABRYSVO®
Along with RENOIR, ABRYSVO has been assessed in RWE studies
Despite their limitations, RWE studies can complement data from randomized controlled trials (RCTs) by providing additional information to inform healthcare decision-making.1,2 Limitations of RWE Studies4-7
RWE analyses can only evaluate association, not causation, and therefore answer different questions than RCTs
RWE results may not always be suitable for direct comparison with RCTs due to differences in study design
The source and type of data used may limit the ability to generalize results and endpoints
There are varying levels of data availability and quality, including missing or incorrectly coded data and fewer standards around study designs, which may lead to a range of robustness in RWE studies
Review RWE studies evaluating RSV vaccine effectiveness that build on a growing body of evidence for ABRYSVO8-14KAISER RWE
The Tartof, et al. study (Kaiser) is a retrospective, case-control study with a test-negative design conducted with Kaiser Permanente of Southern California.8
Study limitations8
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 the entire population
These early first-season estimates missed the first part of RSV season, resulting in lower median follow-up times
Certain vaccine effectiveness estimates include wide confidence intervals, due to small sample size. Study will continue to accrue cases to power future analyses
Explore the Analysis Loading Explore the Analysis LoadingDAN-RSV RWE
The Lassen, et al. study (DAN-RSV), published in The New England Journal of Medicine, is a registry-based, open-label, randomized clinical trial conducted using pragmatic data collection in an adult population.9
Study limitations9
Open-label trial, although not anticipated to impact hospitalization endpoints
Conducted in a single country, and the participants may not fully represent global populations
Fewer events occurred than anticipated, likely influenced by undertesting in routine care and a milder RSV season
Use of electronic invitations, along with the ability to provide independent informed consent may have limited the inclusion of older, high-risk individuals
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References: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. 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. 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. 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. Lassen MCH, Johansen ND, Christensen SH, et al. RSV prefusion F vaccine for prevention of hospitalization in older adults. N Engl J Med. Published online August 30, 2025. doi:1056/NEJMoa2509810 Surie D, Self WH, Zhu Y, et al. RSV vaccine effectiveness against hospitalization among US adults 60 years and older. JAMA. 2024;332(13):1105-1107. Payne AB, Watts JA, Mitchell PK, et al. Respiratory syncytial virus (RSV) vaccine effectiveness against RSV-associated hospitalisations and emergency department encounters among adults aged 60 years and older in the USA, October, 2023, to March, 2024: a test-negative design analysis. Lancet. 2024;404(10462):1547-1559. Bajema KL, Yan L, Li Y, et al. Respiratory syncytial virus vaccine effectiveness among US veterans, September, 2023 to March, 2024: a target trial emulation study. Lancet Infect Dis. 2025;25(6):625-633. Surie D. Effectiveness of adult respiratory syncytial virus (RSV) vaccines, 2023–2024. Presented at: Advisory Committee on Immunization Practices meeting; June 26, 2024; Atlanta, GA. Accessed December 2, 2025. https://stacks.cdc.gov/view/cdc/157861 Fry SE, Terebuh P, Kaelber DC, Xu R, Davis PB. Effectiveness and safety of respiratory syncytial virus vaccine for US adults aged 60 years or older. JAMA Netw Open. 2025;8(5):e258322.
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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