SAFETY PROFILE

Solicited local adverse reactions within 7 days of vaccination (ZOE-50/-70)*

  50-59 years old 60-69 years old ≥70 years old
Local adverse reactions SHINGRIX %
n=1315		 Placebo %
n=1312		 SHINGRIX %
n=1311		 Placebo %
n=1305		 SHINGRIX %
n=2258		 Placebo %
n=2263
Pain 88 14 83 11 69 9
Pain, Grade 3* 10 1 7 1 4 0.2
Redness 39 1 38 2 38 1
Redness, >100 mm 3 0 3 0 3 0
Swelling 31 1 27 1 23 1
Swelling, >100 mm 1 0 1 0 1 0

Review age-specific safety data using the tabs below

50-59
years old		 60-69
years old		 ≥70
years old
Local adverse reactions SHINGRIX %
n=1315		 Placebo %
n=1312
Pain 88 14
Pain, Grade 3* 10 1
Redness 39 1
Redness, >100 mm 3 0
Swelling 31 1
Swelling, >100 mm 1 0
Local adverse reactions SHINGRIX %
n=1311		 Placebo %
n=1305
Pain 83 11
Pain, Grade 3* 7 1
Redness 38 2
Redness, >100 mm 3 0
Swelling 27 1
Swelling, >100 mm 1 0
Local adverse reactions SHINGRIX %
n=2258		 Placebo %
n=2263
Pain 69 9
Pain, Grade 3* 4 0.2
Redness 38 1
Redness, >100 mm 3 0
Swelling 23 1
Swelling, >100 mm 1 0

In ZOE-50/-70, data on solicited local and general adverse reactions were collected using standardized diary cards for 7 days following each vaccine dose or placebo (ie, day of vaccination and the next 6 days) in a subset of subjects (n=4886 receiving SHINGRIX, n=4881 receiving placebo with at least 1 documented dose). Solicited local adverse reactions were collected in subjects 50-69 years old from ZOE-50 and from pooled data from ZOE-50/-70 for subjects ≥70 years old.

 

  • *

    Grade 3 pain defined as significant pain at rest; prevents normal everyday activities.

  •  

    n = number of subjects with at least 1 documented dose of either SHINGRIX or placebo included in the total vaccinated cohort for safety.

Solicited general adverse reactions within 7 days of vaccination by age (ZOE-50/-70)*

  50-59 years old 60-69 years old ≥70 years old
General adverse reactions SHINGRIX %
n=1315		 Placebo %
n=1312		 SHINGRIX %
n=1309		 Placebo %
n=1305		 SHINGRIX %
n=2252		 Placebo %
n=2264
Myalgia 57 15 49 11 35 10
Myalgia, Grade 3* 9 1 5 1 3 0.4
Fatigue 57 20 46 17 37 14
Fatigue, Grade 3* 9 2 5 1 4 1
Headache 51 22 40 16 29 12
Headache, Grade 3* 6 2 4 0.2 2 0.4
Shivering 36 7 30 6 20 5
Shivering, Grade 3* 7 0.2 5 0.3 2 0.3
Fever† 28 3 24 3 14 3
Fever, Grade 3‡ 0.4 0.2 1 0.2 0.1 0.1
GI§ 24 11 17 9 14 8
GI, Grade 3* 2 1 1 1 1 0.4

Review age-specific safety data using the tabs below

50-59
years old		 60-69
years old		 ≥70
years old
General adverse reactions SHINGRIX %
n=1315		 Placebo %
n=1312
Myalgia
 57 15
Myalgia, Grade 3*
 9 1
Fatigue
 57 20
Fatigue, Grade 3*
 9 2
Headache
 51 22
Headache, Grade 3*
 6 2
Shivering 36 7
Shivering, Grade 3* 7 0.2
Fever† 28 3
Fever, Grade 3‡ 0.4 0.2
GI§ 24 11
GI, Grade 3* 2 1
General adverse reactions SHINGRIX %
n=1309		 Placebo %
n=1305
Myalgia
 49 11
Myalgia, Grade 3*
 5 1
Fatigue
 46 17
Fatigue, Grade 3*
 5 1
Headache
 40 16
Headache, Grade 3*
 4 0.2
Shivering 30 6
Shivering, Grade 3* 5 0.3
Fever† 24 3
Fever, Grade 3‡ 1 0.2
GI§ 17 9
GI, Grade 3* 1 1
General adverse reactions SHINGRIX %
n=2252		 Placebo %
n=2264
Myalgia
 35 10
Myalgia, Grade 3*
 3 0.4
Fatigue
 37 14
Fatigue, Grade 3*
 4 1
Headache 29 12
Headache, Grade 3*
 2 0.4
Shivering 20 5
Shivering, Grade 3* 2 0.3
Fever† 14 3
Fever, Grade 3‡ 0.1 0.1
GI§ 14 8
GI, Grade 3* 1 0.4

In ZOE-50/-70, data on solicited local and general adverse reactions were collected using standardized diary cards for 7 days following each vaccine dose or placebo (ie, day of vaccination and the next 6 days) in a subset of subjects (n=4886 receiving SHINGRIX, n=4881 receiving placebo with at least 1 documented dose). Solicited general adverse reactions were collected in subjects 50-69 years old from ZOE-50 and from pooled data from ZOE-50/-70 for subjects ≥70 years old.

 

  • *

    Grade 3 myalgia, fatigue, headache, shivering, and GI: defined as preventing normal activity.

  • †

    Fever defined as ≥37.5°C/99.5°F for oral, axillary, or tympanic route, or ≥38°C/100.4°F for rectal route.

  • ‡

    Grade 3 fever defined as >39.0°C/102.2°F.

  • §

    Included nausea, vomiting, diarrhea, and/or abdominal pain.

  •  

    n = number of subjects with at least 1 documented dose of either SHINGRIX or placebo included in the total vaccinated cohort for safety.

Percentage of adults with serious adverse events, deaths, and potential immune-mediated disorders from first administered dose up to 1-year post vaccination.

Rates observed during 1-year follow-up period

  SHINGRIX % Placebo %
Serious adverse reactions 10.1 10.4
Deaths* 0.8 0.9
Potential immune-mediated diseases 0.6 0.7

Evaluated by pooling safety data from ZOE-50/-70 involving 29,305 patients (n= 14,645 receiving SHINGRIX) and (n = 14,660 receiving placebo).

 

  • *

    Causes of death among subjects were consistent with those generally reported in adult and elderly populations.

Indication & Important Safety Info

Indication

Important Safety Information

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

  • in adults aged 50 years and older.
  • in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

  • SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
  • Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX
  • In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX
  • Syncope (fainting) can be associated with the administration of injectable vaccines, including SHINGRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Solicited local adverse reactions reported in individuals aged 50 years and older were pain (78%), redness (38%), and swelling (26%)
  • Solicited general adverse reactions reported in individuals aged 50 years and older were myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and gastrointestinal symptoms (17%)  
  • Solicited local adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were pain (88% and 83%), redness (30% and 35%), and swelling (21% and 18%)  
  • Solicited general adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were fatigue (64% and 54%), myalgia (58% and 52%), headache (44% and 30%), gastrointestinal symptoms (21% and 28%), shivering (31% and 25%), and fever (28% and 18%)
  • The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women
  • It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

 

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at https://gsk.public.reportum.com or
1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

References

1. Prescribing Information for SHINGRIX.

    Questions About SHINGRIX?

    Call: 1-800-772-9292

    Available Monday - Friday

    8:30 am to 5:30 pm ET