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ABRYSVO® provides your patients aged 60+ powerful protection against the threat of RSV1Efficacy View 2-Season Data LoadingPrimary endpoints in an RSV clinical trial of ~37,000 adults aged 60 years and older1*Symptoms include cough, wheezing, sputum production, shortness of breath, and tachypnea.1ReferencesEvaluable efficacy population.1Vaccine efficacy, against RSV-LRTD, defined as the relative risk reduction of first episode of RSV-LRTD in the ABRYSVO group compared to the placebo group in the first RSV season, was assessed.1Study design
Pivotal phase 3 study: RENOIR
Multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ABRYSVO1
Adults aged 60 years and older (median age, 67 years) who were healthy or had stable chronic diseases1,2
~37,000 participants were randomized 1:1 to receive ABRYSVO (120 µg, n=18,487) or placebo (n=18,479)1
Randomization was stratified by age group, and ABRYSVO was given to 18,574 patients between 60-69 years (n=11,619), 70-79 years (n=5,928), and ≥80 years (n=1,026)1
Prespecified underlying medical conditions included heart disease, lung disease, having ≥1 chronic cardiopulmonary conditions (asthma, COPD, or CHF), diabetes, liver disease, renal disease, or current tobacco use2
Participants were followed for up to 2 RSV seasons1
Primary endpoint2
Relative risk reduction (vs placebo) of first episode of RSV-LRTD in the first RSV season‡
Endpoint was stratified by ≥2 and ≥3 lower respiratory symptoms (new or worsened, including: cough, wheezing, sputum production, shortness of breath, tachypnea)
ReferencesAs determined by positive RT-PCR test within 7 days of symptom onset and lasting more than 1 day during the same illness.1High-risk populations were included in the RENOIR study1,2ABRYSVO: continued protection against RSV–LRTD across 2 seasons1§
RSV has only 2 subgroups (RSV-A and RSV-B) that circulate each season.3ABRYSVO is a bivalentvaccine, containing equal proportions of RSV-preF A and RSV-preF B as the antigens.1
ReferencesStudied in RENOIR, a phase 3 pivotal study in which participants were followed for up to 2 RSV seasons.1Season 1 and season 2 vaccine efficacy estimates reflect efficacy data from 2 RSV seasons, from August 2021 through November 2023. Vaccine efficacy across 2 seasons reflects efficacy against first events occurring any time during season 1 and season 2.1,4Additional participants were included in the descriptive efficacy analysis for Season 1; ABRYSVO (n=18,050) and placebo (18,074). The median duration of follow-up for efficacy was 7.4 months.1CHF=chronic heart failure; CI=confidence interval; COPD=chronic obstructive pulmonary disease; LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus; RSV-preF=respiratory syncytial virus prefusion F; RT-PCR=reverse transcription-polymerase chain reaction; VE=vaccine efficacy.Related ContentOrder ABRYSVOLoadingVaccine LocatorLoadingAbout ABRYSVO
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References:ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; June 2025.Walsh EE, Pérez Marc G, Zareba AM, et al; for the RENOIR Clinical Trial Group. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. N Engl J Med. 2023;388(16):1465-1477.Nuttens C, Moyersoen J, Curcio D, et al. Differences between RSV A and RSV B subgroups and implications for pharmaceutical preventive measures. Infect Dis Ther. 2024;13(8):1725-1742.Walsh EE, Pérez Marc G, Falsey AR, et al. RENOIR Trial— RSVpreF vaccine efficacy over two seasons. N Engl J Med. 2024;391(15):1459-1460.
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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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