PROVEN OUTSTANDING EFFICACY

SHINGRIX delivered greater than 90 percent efficacy against shingles graphic

Data from ZOE-50 and pooled analysis from ZOE-50/-70.

EFFICACY AGAINST SHINGLES BY AGE IN ADULTS ≥50 YEARS OLD1

Age

Efficacy

Shingles cases (n) in SHINGRIX group (N)

Shingles cases (n) in placebo group (N)

50-59 years old*

96.6%

(95% CI: 89.6, 99.3)

3 (3492)

87 (3525)

60-69 years old*

97.4%

(95% CI: 90.1, 99.7)

2 (2141)

75 (2166)

70-79 years old†

91.3%

(95% CI: 86.0, 94.9)

19 (6468)

216 (6554)

Age ≥80†

91.4%

(95% CI: 80.2, 96.9)

6 (1782)

68 (1792)

The studies were not designed to assess vaccine efficacy by pre-existing medical conditions.

  • *

    Data from the ZOE-50 phase 3 trial.

  • †

    Pooled data from ZOE-50 and ZOE-70 phase 3 trials.

CI=confidence interval; n=number of subjects having ≥1 confirmed herpes zoster episode; N=number of subjects in each group.

CASES & INCIDENCE OF POSTHERPETIC NEURALGIA (PHN)1,2

Cases and incidences of postherpetic neuralgia in pivotal clinical trials

The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ. The efficacy of SHINGRIX in the prevention of PHN in subjects with confirmed herpes zoster (HZ) could not be demonstrated.1

  • *

    Number of subjects having PHN/number of subjects included in each group. PHN defined as HZ-associated pain rated as 3 or greater (on a 0- to 10-point scale) occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.1

  • †

    Data from ZOE-50 phase 3 trial.2

  • ‡

    Pooled data from ZOE-50 and ZOE-70 phase 3 trials.1

HZ=herpes zoster; PHN=postherpetic neuralgia.

LONG-TERM FOLLOW-UP:
STUDY DESIGN AND LIMITATIONS5

Descriptive Analyses

Historical controls were used to estimate the long-term efficacy of SHINGRIX.
There are limitations related to the use of historical controls.

Open-label, phase 3b, multicenter extension study of the ZOE-50/-70 clinical trials

  • Among the 13,881 patients from the mTVC who received SHINGRIX in the ZOE-50/-70 trials, 7273 participants were included in the mTVC of the extension trial*
  • Participants who received placebo in the ZOE-50/-70 studies were offered vaccination with SHINGRIX at study completion. No unvaccinated placebo group was available in the LTFU study; a historical control constructed with ZOE-50/-70 placebo data was used for the vaccine efficacy calculation for LTFU
  • In the LTFU study, participants were followed for up to 6 years (starting at a median of 5.6 years post-vaccination in ZOE-50/-70 and ending at a median of 11.4 years post-vaccination)
  • HZ cases during the gap period between ZOE-50/-70 and the LTFU study were not considered in the VE analysis

SHINGRIX long-term data results graphic

Limitations5,6

  • Consider open-label extension study limitations when interpreting results. The open-label extension study was not blinded, all statistical analyses were descriptive, historical controls were utilized, and the results may be subject to analyst bias
  • No direct matching process was utilized for historical controls. Use of historical controls could overestimate efficacy
  • The methodology used assumes incidence rates in the historical control group remain stable over time and does not account for factors external to the study that may affect incidence of HZ (eg, trends in HZ over time and the COVID-19 pandemic)
  • *

    Fifteen participants with confirmed HZ from ZOE-50/-70 were excluded from the primary objective analysis of the LTFU study.

  • †

    Age at time of vaccination.

COVID-19=coronavirus disease 2019; HZ=herpes zoster; LTFU=long-term follow-up; M=month; mTVC=modified Total Vaccinated Cohort; VE=vaccine efficacy; YOA=years of age.

LTFU RESULTS5

Descriptive Analyses

Historical controls were used to estimate the long-term efficacy of SHINGRIX.
There are limitations related to the use of historical controls.

Primary objective:
Vaccine efficacy against HZ during the LTFU in adults ≥50 YOA* 

79.8

%

(95% CI: 73.7, 84.6)

n/N: 69/7258 SHINGRIX vs 341/7258 historical controls†

Incidence rates‡: 1.8 SHINGRIX vs 8.7 historical controls†

Select secondary objective: Vaccine efficacy against HZ by age strata during the LTFU study

Age 50-59 years*

86.7

%

(95% CI: 75.6, 93.4)

n/N: 12/2043 SHINGRIX vs 90/2043 historical controls†

Incidence rates‡: 1.0 SHINGRIX vs 7.7 historical controls†

Age 60-69 years*

87.1

%

(95% CI: 74.2, 94.4)

n/N: 9/1242 SHINGRIX vs 70/1242 historical controls†

Incidence rates‡: 1.3 SHINGRIX vs 10.1 historical controls†

Age 70-79 years*

71.9

%

(95% CI: 60.1, 80.6)

n/N: 41/3349 SHINGRIX vs 146/3349 historical controls†

Incidence rates‡: 2.3 SHINGRIX vs 8.3 historical controls†

Age ≥80 years*

75.9

%

(95% CI: 43.7, 91.1)

n/N: 7/624 SHINGRIX vs 29/624 historical controls†

Incidence rates‡: 2.5 SHINGRIX vs 10.5 historical controls†

  • *

    Age at time of vaccination.

  • †

    Historical control group: based on data from the placebo groups of the parent studies (ZOE-50/-70) with the number of participants (N) and follow-up time assumed to be the same as the vaccinated group.

  • ‡

    Incidence rates of HZ over the duration of the LTFU per 1000 person-years.

CI=confidence interval; HZ=herpes zoster; LTFU=long-term follow-up; N=number of individuals included in each group; n=number of individuals having a confirmed HZ episode. For the historical control group, n represents the number of projected cases of HZ based on incidence rate data from the placebo group from ZOE-50/-70; YOA=years of age.

LTFU RESULTS5

Descriptive Analyses

Historical controls were used to estimate the long-term efficacy of SHINGRIX.
There are limitations related to the use of historical controls.

Select secondary objective:
Overall vaccine efficacy against HZ in adults ≥50 YOA*,† from 1 month post-dose 2 in ZOE-50/-70 to the end of the LTFU

87.7

%

(95% CI: 84.9, 90.1)

n/N: 101/13,881 SHINGRIX‡ vs 818/14,035 placebo/historical controls§

Select secondary objective: Vaccine efficacy against HZ by year in adults ≥50 YOA†,‖ from 1 month post-dose 2 in ZOE-50/-70 to the end of the LTFU
SHINGRIX long-term data by year in adults 50 plus

    

  • *

    Patient follow-up varied from up to ~4 years in ZOE-50/-70 (for patients not enrolled in the LTFU extension study) and up to ~11 years for patients enrolled in the LTFU study.

  • †

    Age at time of vaccination.

  • ‡

    Data from participants in SHINGRIX groups in ZOE-50/-70 were used for Y1-4, and data from participants in the SHINGRIX group of the LTFU study were used for Y6 onward.

  • §

    Data from participants in the placebo groups of ZOE-50/-70 were used for Y1-4 and data from participants in the placebo groups in ZOE-50/-70 were used to form the historical control data for Y6 onward, with the number of participants (N) and follow-up time in the historical control group assumed to be the same as the vaccinated group during the LTFU study.

  • ||

    HZ cases during the gap period between ZOE-50/-70 and the LTFU study were not considered in the VE analysis.


CI=confidence interval; HZ=herpes zoster; LTFU=long term follow-up; N=number of individuals included in each group; n=number of individuals having ≥1 confirmed HZ episode. For the historical control group, n represents the number of projected cases of HZ based on incident rate data from the placebo groups in ZOE-50/-70; Y=year; YOA=years of age.

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 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.
  2. Cunningham AL, Lal H, Kovac M, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-1032.
  3. Lal H, Cunningham AL, Godeaux O, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;371(22):2087-2096.
  4. Data on file. Study 113077 (NCT01165229). GSK Study Register. Accessed July 1, 2025. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=113077
  5. Strezova A, Domingo JD, Cunningham AL, et al. Final analysis of the ZOE-LTFU trial to 11 years post-vaccination; efficacy of the adjuvanted recombinant zoster vaccine against herpes zoster and related complications. eClinicalMedicine. 2025;83:103241. 
  6. Food and Drug Administration (FDA). Guidance for Industry E 10 Choice of Control Group and Related Issues in Clinical Trials. U.S. Department of Health and Human Services Food and Drug Administration. 2001. Accessed July 1, 2025. https://www.fda.gov/media/71349/download

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