A Demonstrated Safety Profile1

For patients aged 60 years and older

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in individuals aged 60 years 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  

 

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 days, and the systemic adverse reactions reported with AREXVY had a median duration ranging between 1 and 2 days.1
Similar rates of SAEs (4.2% vs 4.0%) and pIMDs (0.3% vs 0.3%) were reported between AREXVY (n=12,467) and placebo (n=12,499), respectively.1
Deaths were reported in 0.8% and 0.9%
of participants who received AREXVY (n=12,470) and placebo (n=12,503), respectively.

  • STUDY 1 DESIGNSUP1

    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 up to approximately 12 months post-vaccination in 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.1

For patients aged 50-59 years

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination from Study 4 (exposed set)

 

 

 

 

  AREXVY 50-59 YOA % Placeboa 50-59 YOA %
Local Adverse Reactions N=756
 N=379

 

  Pain, Anyb 75.8 12.1  
  Pain, Grade 3b 3.4 0.3  
  Erythema, >20 mm 13.2 0.5  
  Erythema, >100 mm 0.5 0  
  Swelling, >20 mm 10.4 0.8  
  Swelling, >100 mm 0.1 0  

 

Systemic Adverse Reactions N=756
 N=380

 

  Fatigue, Anyc 39.8 18.2  
  Fatigue, Grade 3c 2.8 0.8  
  Myalgia, Anyc 35.6 9.7  
  Myalgia, Grade 3c 2.5 0.5  
  Headache, Anyc 31.7 16.8  
  Headache, Grade 3c 2.6 1.1  
  Arthralgia, Anyc 23.4 7.9  
  Arthralgia, Grade 3c 1.7 0.8  
  Fever, ≥38.0 °C/100.4 °Fd 3.2 1.1  
  Fever, >39.0 °C/102.2 °Fd 0.1 0.5  

N=exposed set included all participants with at least 1 documented dose and with completed diary card.

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 or axillary).

The median duration of solicited local and systemic adverse reactions after AREXVY vaccination was 2-3 days and 1-2 days, respectively.1
The rates of solicited local and systemic adverse reactions were similar in participants 50-59 years of age with or without medical conditions associated with an increased risk of RSV-LRTD.1
Among participants 50-59 years of age, serious adverse events (2.3% vs 2.1%), deaths (0.5% vs 0.3%), and potential immune-mediated diseases (0.5% vs 0.3%) were reported after receiving AREXVY (N=769) or placebo (N=383), respectively.1

  • STUDY 4 DESIGNSUP1

    The safety of AREXVY was evaluated in a phase 3, observer-blind, randomized, placebo-controlled study conducted in Argentina, Canada, Germany, Japan, the Netherlands, Poland, Spain, and the United States, in participants 50 through 59 years of age (n=769 AREXVY; n=383 saline placebo), including a subset of participants with stable chronic medical conditions associated with an increased risk for LRTD caused by RSV defined as chronic pulmonary disease, chronic cardiovascular disease, diabetes, or chronic kidney or liver disease (n=386 AREXVY; n=191 saline placebo). The study also enrolled participants 60 years of age and older (n=381 AREXVY).

    Participants were monitored for solicited adverse reactions during the 4 days following vaccination, and for unsolicited adverse events during the 30-day period following vaccination using standardized paper diary cards.

    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 within 12 months after vaccination were reported.

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