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SHINGRIX▼ nearly eliminates the risk of developing PHN by preventing shingles1

The same results were first published in the New England Journal of Medicine.*
*The graph has been independently created by GSK from the original data.

sustained_img02

Pooled data from ZOE-50 (subjects ≥50 years old) and ZOE-70 (subjects ≥70 years old). PHN was defined as HZ-associated pain rated as ≥3 on a 0-10 scale, occurring or persisting for more than 90 days following the onset of rash using the Zoster Brief Pain Inventory questionnaire.1

group_7

REDUCTION OF THESE SHINGLES-RELATED COMPLICATIONS2
The evaluated HZ-related complications were: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease, and stroke. In the pooled analysis of ZOE-50 and ZOE-70, SHINGRIX▼ significantly reduced these HZ-related complications by 93.7% (95% CI: 59.5; 99.9) and 91.6% (95% CI: 43.3; 99.8) in adults ≥50 years (1 vs.16 cases) and adults ≥70 years (1 vs.12 cases), respectively.

Efficacy remains high 4 years post vaccination and
continues to be monitored1,2*

Study Design: Pooled data from the ZOE-50 phase 3 trial (subjects ≥50 years old) and the ZOE-70 phase 3 trial (subjects ≥70 years old)—2 placebo-controlled, observer-blind, phase 3 trials conducted in 18 countries among immunocompetent individuals who were randomized to receive 2 doses (0 and 2 months) of either SHINGRIX▼ or placebo. The primary efficacy analysis included all subjects who did not develop a confirmed case of herpes zoster within 1 month after the second dose.1-4

*Cases/1000 person-years in vaccinated versus placebo are 0.2 vs 10.1, 0.9 vs 11.1, 1.2 vs 7.7, and 1.0 vs 8.2 for year 1, 2, 3, and 4, respectively (P<0.001).1

Number of patients vaccinated vs received placebo are 8250 vs 8346, 8039 vs 8024, 7736 vs 7661, 7426 vs 7267 for year 1, 2, 3, and 4, respectively.1

Data shown in the graph represents subjects ≥70 years of age from the pooled analysis of ZOE-50 and ZOE-70. The efficacy of SHINGRIX▼ continues to be monitored.1,2

The same results were first published in the New England Journal of Medicine.‡
‡The graph has been independently created by GSK from the original data.

CI=confidence interval; HZ=herpes zoster; PHN=postherpetic neuralgia.

Shingrix▼ Safety Information2

Contraindications:
Hypersensitivity to the active substances or to any component of the vaccine.

Special warnings and precautions:
As with all injectable vaccines:
- appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine;
- vaccination with Shingrix▼ should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination;
- a protective immune response may not be elicited in all vaccinees.
Do not administer the vaccine intravascularly, intradermally or subcutaneously.
There are no data on the use of Shingrix▼ in pregnant women and the effect on breast-fed infants of administration of Shingrix▼ to their mothers has not been studied.

Adverse reactions:
- Very common (≥1/10): headache, gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), myalgia, injection site reactions (such as pain, redness, swelling), fatigue, chills, fever.
- Common (≥1/100 to <1/10): injection site pruritus, malaise.
Please refer to the full prescribing information for further details.

References

  1. 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.
  2. Approved prescribing information by SFDA for Shingrix▼.
  3. 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.
  4. US Food and Drug Administration; Vaccines and Related Biological Products Advisory Committee. Briefing document: Shingrix▼ (Zoster Vaccine Recombinant, Adjuvanted). 2017 [accessed May 2020]. Available from: https://www.fda.gov/media/107553/download.
  5. Kilgore PE, Kruszon-Moran D, Seward JF, Jumaan A, Van Loon FP, Forghani B, et al. Varicella in Americans from NHANES III: implications for control through routine immunization. J Med Virol. 2003;70(suppl 1):S111-18.
  6. Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007 Mar;356(13):1338-43.
  7. Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008 May;57(RR-5):1-30.
  8. Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol. 2012 Aug;24(4):494-500.
  9. Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JAR, 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.
  10. Bharucha T, Ming D, Breuer J. A critical appraisal of ‘Shingrix▼’, a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Hum Vaccin Immunother. 2017 Aug;13(8):1789-97.

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. To report Adverse Event/s associated with the use of GSK product/s, please contact us via saudi.safety@gsk.com

For more information, please refer to the prescribing information or contact GSK: P.O Box 55850, Jeddah, 21544, Kingdom of Saudi Arabia.
Telephone: +966 12 653 6666 or via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via saudi.safety@gsk.com
To report the Quality related product complaint/s associated with the use of GSK product/s, please contact us via ksa.productqualitycomplaint@gsk.com

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GlaxoSmithKline, Jeddah, 21544, Kingdom of Saudi Arabia.

PM-SA-SGX-WCNT-240011 Date of preparation: September 2025