Indications for: SHINGRIX
Prevention of herpes zoster (shingles): in adults ≥50yrs of age; or in adults ≥18yrs of age at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy.
Limitations of Use:
Not for preventing primary varicella infection (chickenpox).
The FDA approval of Shingrix was supported by data from the phase 3 clinical trial program that assessed its safety, efficacy, and immunogenicity in over 38,000 individuals aged 50 years and older.
Findings from a pooled analysis showed >90% efficacy against shingles for all age groups and sustained efficacy over a 4-year follow-up. The use of Shingrix also decreased the overall incidence of postherpetic neuralgia.
Study 1: Vaccine Efficacy Results by Age Group
- 50-59 years (n=3492): 96.6% (95% CI, 89.6-99.3)
- 60-69 years (n=2141): 97.4% (95% CI, 90.1-99.7)
- ≥70 year (n=1711): 97.9% (95% CI, 87.9-100)
Study 2: Vaccine Efficacy Results by Age Group
- 70-79 years (n=5114): 90% (95% CI, 83.5-94.3)
- ≥80 years (n=1427): 89.1% (95% CI, 74.7-96.2)
Efficacy in Immunocompromised Individuals 18 Years of Age and Older
The approval was based on data from clinical studies that assessed the efficacy and safety of Shingrix in adults 18 years of age and older who previously had an autologous hematopoietic stem cell transplant (auHSCT; N=1721) and in those undergoing treatment for hematologic malignancies (N=515; post-hoc analysis).
Shingrix was found to be 68.2% (95% CI, 55.5-77.6) effective against the development of herpes zoster in immunocompromised adults who received an auHSCT 50 to 70 days prior to the first dose and who were expected to receive prophylactic antiviral therapy for at most 6 months post-transplant. In the hematologic malignancy study, post hoc analysis showed Shingrix was 87.2% (95% CI, 44.2-98.6) effective against herpes zoster development.
The approval was further supported by safety and immunogenicity data in adults who were, or were anticipated to be immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.
Concomitant Administration With Influenza Vaccine
Immunogenicity and safety were assessed in an open-label, multicenter phase 3 trial of 828 adults aged ≥50 years who received either Fluarix Quadrivalent and Shingrix at month 0 and Shingrix at month 2 (n=413), or Fluarix Quadrivalent at month 0 and Shingrix at month 2 and 4 (n=415).
Results showed that there was no evidence of interference in antibody responses (haemagglutination inhibition [HI] antibodies and anti-gE antibodies) to Fluarix Quadrivalent or Shingrix.
Give by IM inj in deltoid region of upper arm. ≥50yrs: one 0.5mL dose at Month 0 followed by second dose given between 2–6 months later. Immunocompromised (≥18yrs): one 0.5mL dose at Month 0 followed by second dose given between 1–2 months later.
<18yrs: not established.
Allergies to any previous Shingrix vaccination.
Review immunization history prior to administration. Have appropriate medical treatment and supervision available to manage allergic reactions. Increased risk of Guillain-Barré syndrome observed during the 42 days after vaccination. Syncope. Pregnancy. Nursing mothers.
Local reactions (eg, pain, redness, swelling), myalgia, fatigue, headache, shivering, fever, GI symptoms; Guillain-Barre syndrome, transient neurological effects.
To report adverse events, contact VAERS at (800) 822-7967.
Generic Drug Availability:
Single-dose vials—1, 10 (antigen + adjuvant components)