A Demonstrated Safety Profile1

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in adults 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  

 

  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 days. The systemic adverse reactions reported with AREXVY had a median duration ranging between 1 and 2 days.
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 participants who received AREXVY (n=12,467) and placebo (n=12,499), respectively.1

  • STUDY DESIGN

    The safety of AREXVY was evaluated in a placebo-controlled phase 3 clinical study, Study 1 (NCT04886596), 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.1