AREXVY is indicated for active immunization for the prevention of LRTD caused by respiratory syncytial virus in individuals 60 years of age or older.1

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Vaccination may not protect all recipients.1

LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.

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AREXVY is indicated for active immunization for the prevention of LRTD caused by respiratory syncytial virus in individuals 60 years of age or older.1

SCROLL

Vaccination may not protect all recipients.1

LRTD=lower respiratory tract disease;
RSV=respiratory syncytial virus.

Now Approved

Exceptional Efficacy for Your Patients Aged 60 Years and Older1

82.6%

Primary Endpoint

Overall Efficacy
Against RSV-LRTD
(96.95% CI, 57.9, 94.1)

AREXVY (7 cases out of 12,466),
placebo (40 cases out of 12,494)

Study 1, an ongoing phase 3 study, randomized participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). Median follow-up for this analysis was 6.7 months.1

Respiratory syncytial virus–associated lower respiratory tract disease (RSV-LRTD) was defined as at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or at least 3 lower respiratory symptoms for at least 24 hours.1

94.6%

Secondary Endpoint

Efficacy Against RSV-LRTD in
Participants With at Least 1 Comorbidity*
(95% CI, 65.9, 99.9)

AREXVY (1 case out of 4937),
placebo (18 cases out of 4861)

*Comorbidities of interest: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.

Study 1, an ongoing phase 3 study, randomized participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). Median follow-up for this analysis was 6.7 months.1

Respiratory syncytial virus–associated lower respiratory tract disease (RSV-LRTD) was defined as at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or at least 3 lower respiratory symptoms for at least 24 hours.1

  • See the Study Design

    Study Design1

    The efficacy of AREXVY against respiratory syncytial virus–associated lower respiratory tract disease (RSV-LRTD) was evaluated in an ongoing, phase 3, randomized, placebo-controlled, observer-blind study in adults aged 60 years and older in 17 countries from Northern and Southern Hemispheres. The primary population for efficacy analysis (referred to as the modified exposed set) included adults aged 60 years and older receiving 1 dose of AREXVY or placebo and who did not report an RSV-confirmed acute respiratory illness (ARI) prior to Day 15 after vaccination. Participants received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of the primary efficacy analysis, participants had been followed for the development of RSV-associated LRTD for up to 10 months (median of 6.7 months). At the time of first efficacy analysis, the median age of participants was 69 years. At baseline, 39.3% of participants had at least 1 comorbidity of interest. Participants with pre-existing, chronic, stable disease such as diabetes, hypertension, or cardiac disease were allowed to participate in the study if considered by the investigator as medically stable at the time of vaccination. Immunocompromised participants were excluded.​

    The primary objective was to demonstrate the efficacy of AREXVY in the prevention of a first episode of confirmed RSV-A and/or B-associated LRTD during the first season. Confirmed RSV cases were determined by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) on a nasopharyngeal swab during all ARI episodes.​

    ARI was defined by the presence of at least 2 respiratory symptoms/signs for at least 24 hours (nasal congestion, sore throat, lower respiratory symptoms/signs), or at least 1 respiratory symptom/sign plus 1 systemic symptom/sign (fever or feverishness, fatigue, body aches, headache, decreased appetite) for at least 24 hours.​

    LRTD was defined as at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or at least 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, crackles/rhonchi, respiratory rate ≥20 respirations/min, low or decreased oxygen saturation (O2 saturation <95% or ≤90% if baseline is <95%), and need for oxygen supplementation.​

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A Demonstrated Safety Profile1

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in adults 60 years of age and older (solicited safety set with 4-day diary card)

 

 

  AREXVY % Placeboa %
Local Adverse Reactions N=879
 N=874

 

  Pain, Anyb 60.9 9.3  
  Pain, Grade 3b 1 0  
  Erythema, >20 mm 7.5 0.8  
  Erythema, >100 mm 0.2 0  
  Swelling, >20 mm 5.5 0.6  
  Swelling, >100 mm 0.2  0  

N=exposed set for solicited safety set included all participants with at least 1 documented dose.

Placebo was a saline solution.

Any grade pain: Defined as any pain neither interfering with nor preventing normal everyday activities (Grade 1), painful when limb is moved and interferes with everyday activities (Grade 2), or significant pain at rest and prevents normal everyday activities (Grade 3).

Any grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).

Temperature taken by any route (oral, axillary, or tympanic).

 

  AREXVY % Placeboa %
Systemic Adverse Reactions N=879
 N=878

 

  Fatigue, Anyc 33.6 16.1  
  Fatigue, Grade 3c 1.7 0.5  
  Myalgia, Anyc 28.9 8.2  
  Myalgia, Grade 3c 1.4 0.3  
  Headache, Anyc 27.2 12.6  
  Headache, Grade 3c 1.3 0  
  Arthralgia, Anyc 18.1 6.4  
  Arthralgia, Grade 3c 1.3 0.6  
  Fever, ≥38.0 °C/
100.4 °Fd		 2.0 0.3  
  Fever, >39.0 °C/
102.2 °Fd		 0.1 0.1  

N=exposed set for solicited safety set included all participants with at least 1 documented dose.

Placebo was a saline solution.

Any grade pain: Defined as any pain neither interfering with nor preventing normal everyday activities (Grade 1), painful when limb is moved and interferes with everyday activities (Grade 2), or significant pain at rest and prevents normal everyday activities (Grade 3).

Any grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).

Temperature taken by any route (oral, axillary, or tympanic).

  • In the solicited safety set, the local administration site adverse reactions reported with AREXVY had a median duration of 2 days1
  • The systemic adverse reactions reported with AREXVY had a median duration ranging between 1 and 2 days1
  • Similar rates of SAEs (4.2% vs 4.0%), deaths (0.4% vs 0.5%), and pIMDs (0.3% vs 0.3%) were reported between AREXVY and placebo, respectively1

  • See the Study Design

    Study Design1

    The safety of AREXVY was evaluated in a placebo-controlled phase 3 clinical study conducted in Europe, North America, Asia, and the Southern Hemisphere (South Africa, Australia, and New Zealand) involving 24,966 participants aged 60 years and older who received AREXVY (n=12,467) or placebo (n=12,499).

    In Study 1, solicited adverse reactions were collected from a subset of study participants (solicited safety set) using standardized paper diary cards during the 4 days (ie, day of vaccination and subsequent 3 days) following a dose of AREXVY (n=879) or placebo (n=874). The other study participants did not prospectively record solicited adverse reactions on a diary card but reported them as unsolicited adverse reactions.

    In all participants from Study 1, unsolicited adverse events were monitored using paper diary cards during the 30-day period following vaccination (day of vaccination and the next 29 days).

    In Study 1, participants were monitored for all serious adverse events (SAEs) that occurred during the 6-month period following administration of AREXVY or placebo.

    Adverse events leading to death were recorded from vaccination through the first analysis of the ongoing Study 1.

    In Study 1, participants were monitored for all potential immune-mediated diseases (pIMDs) that occurred during the 6-month period following administration of AREXVY or placebo.

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Choose AREXVY

for appropriate patients 

Are you ready to take the next step to protect your patients 60 years or older? Now is the time to prepare. 

Not an actual patient.

LRTD=lower respiratory tract disease; pIMD=potential immune-mediated disease; RSV=respiratory syncytial virus; SAE=serious adverse event.