Zoster vaccine recombinant, adjuvanted

(Shingrix®)

Shingrix®

Drug updated on 9/4/2024

Dosage FormInjection (intramuscular; 50 mcg/0.5 mL)
Drug ClassVaccines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for prevention of herpes zoster (HZ) (shingles) in adults aged 50 years and older, and 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.

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Summary
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  • Shingrix (zoster vaccine recombinant, adjuvanted) is indicated for the prevention of herpes zoster (HZ) (shingles) in adults aged 50 years and older, and 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.
  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Stroke Risk Reduction: The herpes zoster vaccine (HZV) was associated with a 22% reduction in stroke risk compared to unvaccinated individuals (OR 0.78; 95% CI 0.68-0.9; P = 0.001). Antiviral therapy did not show a significant reduction in stroke risk.
  • Prevention of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) in Immunocompetent Adults: The recombinant zoster vaccine (RZV) demonstrated 94% efficacy against HZ in adults aged ≥50 years and 91.3% efficacy in adults aged ≥70 years. Efficacy against PHN was 91.2% in adults aged ≥50 years and 88.8% in adults aged ≥70 years.
  • Comparison of RZV and ZVL in Immunocompetent Subjects: RZV demonstrated superior efficacy over ZVL with a relative vaccine efficacy of 84% (95% CI 53%-95%) and a relative vaccine effectiveness of 49% (95% CI 21%-67%).
  • No significant safety signals were identified for the recombinant zoster vaccine (RZV) in both immunocompetent and immunocompromised adults, with increased reactogenicity that did not impact second dose compliance.
  • RZV was associated with a higher incidence of injection-site and systemic adverse events (RR 6.89 for local symptoms and RR 2.23 for systemic symptoms), but no increase in serious adverse events (SAEs) or mortality was observed.
  • Identified Specific Populations and Subgroups: High efficacy in preventing HZ and PHN was observed in immunocompetent older adults, with no significant safety concerns. Immunocompromised patients experienced lower efficacy of RZV compared to immunocompetent adults but still received significant protection against HZ with good tolerability and comparable safety profiles to placebo. Adults with pre-existing pIMDs also showed high efficacy against HZ with no significant increase in SAEs. Both RZV and ZVL were effective in preventing HZ in adults aged ≥50 and ≥70 years, with RZV demonstrating higher efficacy. ZVL was effective in patients with comorbidities, including diabetes and chronic kidney disease. Younger immunocompromised adults (18-49 years) had an acceptable safety profile, with common adverse events being injection-site pain and fatigue.

Product Monograph / Prescribing Information

Document TitleYearSource
Shingrix (zoster vaccine recombinant, adjuvanted) Prescribing Information.2023GlaxoSmithKline, Durham, NC

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines