Zoster vaccine recombinant, adjuvanted

(Shingrix®)

Shingrix®

Drug updated on 5/17/2024

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.

Summary
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  • Zoster vaccine recombinant, adjuvanted (Shingrix) is indicated for the prevention of herpes zoster in adults aged 50 years and older, as well as in those aged 18 years and older who are at increased risk due to immunodeficiency or immunosuppression. It shows high efficacy against herpes zoster in both healthy and immunocompromised adults.
  • Seven comparative evaluation studies of Shingrix were analyzed, covering various population subgroups including older adults, immunocompromised individuals, and patients with pre-existing potential immune-mediated diseases.
  • Shingrix has been reported to have an increased reactogenicity, such as pain at the injection site and fatigue; however, these adverse events were limited in extent and duration. Serious adverse events related to vaccination were rare (<1%), indicating that it does not significantly impact compliance with the second dose nor increase the risk of serious adverse events or death.
  • Compared to Zoster Vaccine Live (ZVL), Shingrix offers superior protection, with a relative vaccine efficacy rate among immunocompetent subjects being higher by 84%. This superiority extends even among individuals who are immunocompromised.
  • Real-world effectiveness studies confirmed good vaccine effectiveness, ranging between 70% - 85%, demonstrating its sustained ability in preventing herpes zoster even amongst patients with comorbidities within real-world settings.
  • The positive assessment of Shingrix was also noted among immunocompromised adults aged between 18 - 49 years, with significant proportions demonstrating humoral and cell-mediated immune responses, ranging from about two-thirds to almost all participants showing response.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines