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Order SHINGRIX

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Vaccine Info Statement

Medical Inquiries

Questions About SHINGRIX?
Call: 1 (800) 772-9292
Available Monday - Friday
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Mechanism of Action (MOA)

Uniquely designed to overcome age-related decline in shingles immunity1-3

The 2-dose series of the recombinant, antigen/Adjuvant System formulation stimulates the immune system to generate a strong and sustained immune response.2,3,*


AGING IMMUNE SYSTEM

Age-related decline in immunity reduces the number and functionality of immune cells1,6-10

IMMUNE RESPONSE
WITH SHINGRIX

The antigen gE and Adjuvant System AS01B enhance VZV-specific immune response in a declining immune system1-3

VZV=varicella zoster virus.

  •   *In a descriptive analysis of the pivotal clinical trials, the efficacy in preventing herpes zoster in adults ≥50 and ≥70 years of age was 93% and 85% respectively in the 4th year post vaccination.

Mechanism of Action Video

See how SHINGRIX helps address age-related decline in shingles immunity.1-3

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Efficacy

Only SHINGRIX delivered >90% efficacy against shingles regardless of age in those 50 years and older.11,†

CDC
Recommendations

See what CDC says about SHINGRIX.

On-Demand
Education

Watch a range of informative videos, including highlights of pivotal trials, and MOA and reconstitution videos.

  •   †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.11

References: 1. Chlibek R, Smetana J, Pauksens K, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745-1753. 2. Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096. 3. Cunningham AL, Lal H, Kovac M, et al, for the ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-1032. 4. Dendouga N, Fochesato M, Lockman L, Mossman S, Giannini SL, Cell-mediated immune responses to varicella-zoster virus glycoprotein E vaccine using both a TLR agonist and QS21 in mice. Vaccine. 2012;30(20):3126-3125. 5. Leroux-Roels G, Marchant A, Levy J, et al. Impact of adjuvants on CD4+ T cell and B cell responses to a protein antigen vaccine: results from a phase II, randomized, multi-center trial. Clin Immunol. 2016;169:16-27. 6. Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol. 2012;24(4):494-500. 7. Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008;57(RR-5):1-30. 8. Kimberlin DW, Whitley RJ. Varicella–zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007;356(13):1338-1343. 9. Patterson-Bartlett J, Levin MJ, Lang N, Schödel FP, Vessey R, Weinberg A. Phenotypic and functional characterization of ex vivo T cell responses to the live attenuated herpes zoster vaccine. Vaccine. 2007;25(41):7087-7093. 10. Weinberg A, Lazar AA, Zerbe GO, et al. Influence of age and nature of primary infection on varicella—zoster virus—specific cell-mediated immune responses. J Infect Dis. 2010;201(7):1024-1030. 11. Prescribing Information for SHINGRIX.

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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