Drug updated on 12/11/2024
Dosage Form | Injection (intramuscular; 50 mcg/0.5 mL) |
Drug Class | Vaccines |
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.
Latest News
Summary
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-12]
- Herpes zoster (HZ) incidence reduced significantly in high-risk populations (140 fewer per 1000), with a minor reduction in healthy populations (28 fewer per 1000). Vaccine efficacy in immunocompetent adults was 94% (≥50 years) and 91.3% (≥70 years); in immunocompromised haematopoietic stem cell transplantation (HSCT) patients, it was 68.2%. For diabetes patients, live-attenuated zoster vaccine (LZV) had 48% effectiveness, and recombinant zoster vaccine (RZV) had 91% efficacy.
- Postherpetic neuralgia (PHN) showed no significant difference in most populations. Vaccine efficacy against PHN was 91.2% in adults ≥50 years, 88.8% in adults ≥70 years, and 89.3% in HSCT patients.
- Herpes zoster vaccination was associated with a reduced risk of dementia, with a pooled odds ratio of 0.84.
- Humoral immune response rate for anti-gE was 95.2% one month after RZV dose 2, decreasing to 77.6% during immunosuppression, while cell-mediated immunity response was 84.6%.
- Adverse events, primarily related to injection-site and systemic reactions such as pain and fatigue, were common across healthy and high-risk populations receiving RZV, though they did not significantly affect second-dose compliance. Serious adverse events (SAEs) were comparable between RZV and placebo groups.
- In immunocompromised adults aged 18-49 years, SAEs were reported in 8.1% to 30.8% of RZV recipients and 4.1% to 36.5% of placebo recipients, with SAEs related to vaccination occurring in less than 1% in both groups.
- Compared to ZVL, RZV-associated adverse events were mainly mild to moderate, with no increased risk of SAEs or death, and no notable differences in adverse event incidence between immunosuppressed and non-immunosuppressed groups.
- RZV demonstrates high effectiveness across various populations, including a 91% efficacy in adults with diabetes, high efficacy in older adults (94% for those ≥50 years, 91.3% for those ≥70 years), and 68.2% efficacy in immunocompromised patients post-HSCT; it also shows significant efficacy in CKD and autoimmune disease populations without increased adverse events, with effectiveness waning more rapidly in the very elderly.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Shingrix (zoster vaccine recombinant, adjuvanted) Prescribing Information. | 2023 | GlaxoSmithKline, Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
A practitioner's guide to the recombinant zoster vaccine: review of national vaccination recommendations. | 2021 | Expert Review of Vaccines |