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Vaccine Info Statement

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Questions About SHINGRIX?
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CDC Recommendations

SHINGRIX: Recommended by the CDC for the prevention of shingles1,*

The CDC states SHINGRIX is1:

Recommended for the prevention of herpes zoster and related complications for immunocompetent adults aged ≥50 years
Recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received zoster vaccine live (ZVL)
Preferred over ZVL for the prevention of herpes zoster and
related complications

Please see Important Considerations below.

See important considerations related to CDC recommendations

View the full CDC recommendations for herpes zoster vaccines

2018 CDC Recommendations: Important Considerations Related to Alternate Dosing, Concomitant Use, Patients Previously Vaccinated With ZVL, and Persons With a Prior History of Herpes Zoster

Alternate Dosing

This article contains dosing schedule information that is inconsistent with the label. According to the Prescribing Information for SHINGRIX, 2 doses (0.5 mL each) should be administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.2

Concomitant Use

SHINGRIX was administered concomitantly with FLUARIX QUADRIVALENT (Influenza Vaccine) in an open-label clinical study of subjects 50 years and older (N=828). There was no evidence of interference in the immune response to any of the antigens contained in SHINGRIX or the coadministered vaccine.2

Patients Previously Vaccinated With ZVL

  • There are limited data on vaccination with SHINGRIX in patients previously vaccinated with ZVL compared to those not previously vaccinated with ZVL3
    • In a phase 3 study, humoral immunogenicity was non-inferior among subjects previously vaccinated at least 5 years earlier with ZVL
    • No apparent safety differences were observed between study groups within 30 days post-dose 2 of SHINGRIX 
    • Solicited local and systemic symptoms were similar between study groups
  • The levels of antibodies and immune cells that correlate with protection against shingles have not been clearly defined

Persons With a Prior History of Herpes Zoster

The pivotal clinical trials for SHINGRIX excluded patients with a prior history of herpes zoster.2

There are no head-to-head clinical trials comparing the efficacy and safety of SHINGRIX to ZVL

*ACIP recommendations adopted by CDC.

ACIP=Advisory Committee on Immunization Practices; CDC=Centers for Disease Control and Prevention.

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Efficacy

Only SHINGRIX delivered >90% efficacy against shingles regardless of age in those 50 years and older.2,†

Reconstitution & Administration

See how you and your staff can reconstitute SHINGRIX in four steps. Vaccinate confidently.

Patient Counseling

Talk to your patients about what to expect, including common adverse reactions.

 

  •   †Data from the phase 3 ZOE-50 (≥50 years of age) trial and pooled data in individuals ≥70 years of age from the phase 3 ZOE-50 and ZOE-70 trials from subjects who received 2 doses of SHINGRIX (N=7344 and 8250, respectively) or placebo (N=7415 and 8346, respectively) and did not develop a confirmed case of herpes zoster within 1 month after the second dose. See study designs on Efficacy page for more details.2

References: 1. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. MMWR. 2018;67(3):103-108. 2. Prescribing Information for SHINGRIX. 3. Grupping K, Campora L, Douha M, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live attenuated herpes zoster vaccine. J Infect Dis. 2017;216(11):1343-1351.

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

  • SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
  • Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX
  • In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX
  • Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%)
  • Solicited general adverse reactions in subjects aged 50 years and older were myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), and gastrointestinal symptoms (17.3%)
  • SHINGRIX was not studied in pregnant or lactating women, and it is unknown if it is excreted in human milk. Therefore, it cannot be established whether there is vaccine-associated risk with SHINGRIX in pregnant women or if there are effects on breastfed infants or milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

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