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SHINGRIX (herpes zoster vaccine, recombinant, adjuvanted) demonstrated >90% efficacy against shingles in all age groups 50 years of age and older, based on pooled data from two large, phase 3 randomised controlled trials.1-3

SHINGRIX efficacy against shingles in patients 50 years of age and older based on pooled data from two large, phase 3 randomised controlled trials.2,3

97% Efficacy Icon for ≥50

EFFICACY AGAINST SHINGLES IN ADULTS ≥50 YEARS

91% Efficacy Icon for ≥70

EFFICACY AGAINST SHINGLES IN ADULTS ≥70 YEARS

*In ZOE-50, VE against shingles was 97.2% in adults ≥50 years (SHINGRIX n/N: 6/7344; placebo n/N:210/7415). Median follow-up period of 3.1 years.2

†In a pooled analysis of VE against shingles ZOE-50 and ZOE-70 (SHINGRIX n/N: 25/8250); placebo n/N: 284/8346). Median follow-up of 4 years.3

Study designs

Study 1 design: Data from ZOE-50—a placebo-controlled, observer-blind, phase 3 trial conducted in 18 countries in which subjects ≥50 years old were randomised to receive 2 doses (0 and 2 months) of either SHINGRIX (N=7698) or placebo (N=7713). A total of 7344 and 7415 subjects who received SHINGRIX and placebo, respectively, were included in the modified Total Vaccinated Cohort (mTVC) analysis.1,2

Study 2 design: Data from ZOE-70—a placebo-controlled, observer-blind, phase 3 trial conducted in 18 countries in which subjects ≥70 years old were randomised to receive 2 doses (0 and 2 months) of either SHINGRIX (N=6950) or placebo (N=6950). A total of 6541 and 6622 subjects who received SHINGRIX and placebo, respectively, were included in the mTVC analysis.1,3

The modified vaccinated cohort (mTVC) - excluded participants who did not receive the second dose of recombinant zoster vaccine or placebo or who had a confirmed case of HZ within 1 month after the second dose.2,3

Pooled analysis: Data from ZOE-50 and ZOE-70 were combined in a prespecified pooled analysis. A total of 8250 and 8346 subjects ≥70 years of age who received SHINGRIX and placebo, respectively, were included.1-3 Exclusion criteria for these studies included subjects with a history of herpes zoster, subjects who had previously been vaccinated against varicella or herpes zoster and those with an immunosuppressive condition.2,3

SHINGRIX provided lasting protection against shingles (11-year follow-up in ZOE-LTFU) in participants ≥50 years old:1,4,5*

79.7% (95% CI:73.7–84.6) efficacy during ZOE-LTFU (Y6 to Y11 since vaccination)1*

87.7% (95% CI: 84.8–90.1) overall efficacy up to year 114,5

eDA chart eDA chart

*SHINGRIX does not protect 100% of individuals vaccinated. Primary objective (pre-planned and descriptive analysis): Vaccine efficacy (VE) against first or only shingles episode over the duration of the ZOE-LTFU study in participants ≥50 years old; follow-up for ~6 years. ZOE-LTFU started at a median of 5.6 years post-vaccination in ZOE-50/70 and ended at a median of 11.4years post-vaccination (modified Total Vaccination Cohort [mTVC], N=7273). Shingles cases(n/N) in SHINGRIX group (69/7258) and historical control (HC) group (341/7258). VE was assessed in the mTVC in individuals ≥50 years old, and participants with confirmed shingles during ZOE-50/70 were not considered. HC in ZOE-LTFU is based on the placebo group in ZOE-50/70 studies, with number of participants (N) and follow-up time assumed to be the sameas in the vaccinated group. VE estimates were adjusted for region.1,5

Secondary objective (pre-planned and descriptive analysis): VE against first or only shingles episode from 1-month post-dose 2 in the ZOE-50/70 studies. Subject follow-up varied, from up to ~4 years in ZOE-50/70 (for participants not enrolled in ZOE-LTFU) to up to ~11 years for subjects enrolled in ZOE-LTFU. ZOE-LTFU started at a median of 5.6 years post-vaccination in ZOE-50/70 and ended at a median of 11.4 years post-vaccination (mTVC, N=7273). Shingles cases (n/N) in SHINGRIX group (101/13,881) and HC group (818/14,035). The placebo group in ZOE-50/70 was used for year 1 through year 4 analysis and to form the HC data for year 6 and onwards analysis in ZOE-LTFU. VE estimates were adjusted for region.5

CI, confidence interval; HC, historical control; LTFU, long-term follow-up; mTVC, modified totalvaccination cohort; N, number of participants; n, number of participants with at least oneconfirmed shingles episode; VE, vaccine efficacy.

ZOE-LTFU Study Design

ZOE-LTFU: ZOE-LTFU was a 6-year follow-up (Y6 to Y11 since vaccination) study to evaluate the persistence of efficacy and safety in adults age ≥50 years vaccinated with SHINGRIX in 2 pivotal efficacy trials (ZOE-50/70).4,5 Annual assessments were performed to evaluate vaccine efficacy (VE) against shingles from Y6 to Y11 since vaccination.4,5 Pre-planned and descriptive VE analysis for ZOE-LTFU used historical control estimates based on the ZOE-50/70 placebo groups.4,5 7258 SHINGRIX-vaccinated participants were included in the VE analysis in modified total vaccinated cohorts (participants receiving 2 doses of SHINGRIX without confirmed shingles within 30 days post-dose 2). No data are available for year 5 as this period corresponds to the gap between the parent studies (ZOE-50/70) and the extension study.4,5

VIEW PHN EFFICACY DATA

Learn more about SHINGRIX

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Who can benefit from SHINGRIX?

There is a 1 in 3 lifetime risk of developing shingles.6 Age-related decline in immunity puts patients 50 years of age and older at an increased risk of developing shingles.7,8

View Patient Profiles

varicella zoster virus

Addressing age-related decline in immunity.

SHINGRIX – specifically formulated to help address age-related decline in varicella zoster virus specific immunity in adults 50 years of age and older.1,10,11

REVIEW SCIENTIFIC RATIONALE

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Learn more about the safety profile of SHINGRIX.

The majority of local and systemic adverse reactions were mild to moderate and transient, based on two large, phase 3 randomised controlled trials. Reactions reported as severe lasted 1 to 2 days.1-3

Explore safety data

References

  1. Shingrix, Summary of Product Characteristics (SPC), available on https://www.medicines.ie/medicines/shingrix-powder-and-suspension-for-suspension-for-injection-herpes-zoster-vaccine-recombinant-adjuvanted--35192/spc. Last Accessed: May 2025
  2. Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang S-J, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May;372 (22):2087-96.
  3. Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang S-J, Diez-Domingo J, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016 Sep;375 (11):1019-32.
  4. Strezova A, Diez-Domingo J, Tinoco JC, et al. Adjuvanted recombinant zoster vaccine (RSZ) is there first vaccine to provide durable protection against herpes zoster (HZ) in all age ranges ≥50 years: final analysis of efficacy and safety after 11 years (Y) of follow-up. Presented at: ECCMID 2024; 27-30 April 2024: Barcelona, Spain
  5. Strezova A et al. Final analysis of the ZOE-LTFU trial to 11 years postvaccination: efficacy of the adjuvanted recombinant zoster vaccine against herpes zoster and related complications. eClinicalMedicine 2025;83:
  6. Harpaz R, et al. MMWR Recomm Rep. 2008 June;57(RR-5):1-30.
  7. Bollaerts K et al. A systematic review of varicella seroprevaience in European countries before universal childhood immunization: deriving incidence from seroprevaience data. Epidemiol. Infect. (2017), 145, 2666-2677.
  8. Gauthier et al. Epidemiology and costs of herpes zoster and postherpetic neuralgia in the United Kingdom. Epidemiol infecti. 2009 137 38-472.
  9. Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007 Mar;356 (13):1338-43.
  10. Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JA, Richardus JH, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014 Mar;32 (15):1745-53.
  11. Leroux-Roels I, Leroux-Roels G, Clement F, Vandepapelière P, Vassilev V, Ledent E, Heineman TC. A phase 1 /2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. J Infect Dis. 2012 Oct;206 (8):1280-90.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

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PM-IE-SGX-WCNT-250003 Date of Preparation: May 2025