About ZOSTAVAX

ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).

Select Safety Information for ZOSTAVAX® (Zoster Vaccine Live)

Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.

Do not administer ZOSTAVAX to individuals who are immunodeficient or immunosuppressed due to disease or therapy, as serious or fatal disseminated vaccine strain varicella-zoster virus disease may occur. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency states, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, and immunosuppressive therapy.

A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.

Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). Common adverse reactions occurring in ≥1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.

Transmission of vaccine virus may occur between vaccinees and susceptible contacts.

Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.

Before administering ZOSTAVAX® (Zoster Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available.

1. Insinga RP, Itzler RF, Pellissier JM, et al. The incidence of herpes zoster in a United States administrative database J Gen Intern Med. 2005;20(8):748–753.
2. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0015.
3. Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1–30.
4. Johnson RW, Bouhassira D, Kassianos G, et al. The impact of herpes zoster and post-herpetic neuralgia on quality-of-life. BMC Med. 2010;8(37). doi:10.1186/1741-7015-8-37.
5. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1203696-0003.
6. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0002.
7. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0016.
8. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1114216-0004.

Efficacy in Adults Aged 50 Years or Older

  • ZOSTAVAX Efficacy and Safety Trial (ZEST)
    ZOSTAVAX Efficacy and Safety Trial (ZEST)
    ZOSTAVAX Efficacy and Safety Trial assessed efficacy of ZOSTAVAX in 22,439 subjects aged 50 to 59 years.a

    70%

     
    Significant reduction of the risk of zoster
    99 placebo group cases (n=11,228) vs 30 ZOSTAVAX group cases (n=11,211) [95% CI: 54–81]
    • Postherpetic neuralgia (PHN) was not evaluated in patients aged 50 to 59 years.
    • The duration of protection beyond 4 years after vaccination with ZOSTAVAX is unknown.
      The need for revaccination has not been defined, but is currently under study.
    Study Design for ZEST: Efficacy was evaluated in a placebo-controlled, double-blind study of ZOSTAVAX. 22,439 subjects aged 50 to 59 years were randomized to receive a single dose of either ZOSTAVAX (n=11,211) or placebo (n=11,228) and were monitored for the occurrence of shingles for a median of 1.3 years postvaccination (range, 0 to 2 years).
  • Shingles Prevention Study (SPS)
    Shingles Prevention Study (SPS)
    Shingles Prevention Study assessed efficacy of ZOSTAVAX in 38,546 subjects aged ≥60 years. Vaccine efficacy for the prevention of zoster was highest for those subjects aged 60 to 69 years and declined with increasing age.
    Reduction of zoster incidence compared with placebob
    Percent Reduction of Herpes Zoster Incidence by Age Group
    60–69 years
    64%
    334 cases in the placebo group (n=10,356) vs 122 cases in the ZOSTAVAX group (n=10,370) [95% CI: 56–71]
    70–79 years
    41%
    261 cases in the placebo group (n=7,559) vs 156 cases in the ZOSTAVAX group (n=7,621) [95% CI: 28–52]
    ≥80 years
    18%
    47 cases in the placebo group (n=1,332) vs 37 cases in the ZOSTAVAX group (n=1,263) [95% CI: -29–48; not significant]
    overall in subjects aged ≥60 years
    51%
    Significant reduction of the risk of zoster
    642 cases in the placebo group (n=19,247) vs 315 cases in the ZOSTAVAX group (n=19,254) [95% CI: 44–58]
    In a subset of patients aged
    ≥60 years who received
    ZOSTAVAX and developed
    zoster postvaccination...
    39%
     
    Overall lower incidence of PHN as
    compared to those in the placebo group

    Age-adjusted estimate based on age
    strata (aged 60 to 69 years and ≥70 years)
    at randomization.

    The benefit of ZOSTAVAX in the prevention of PHN can be primarily attributed to the effect of the vaccination on the prevention of zoster

    In the SPS, PHN was defined as clinically significant zoster-associated pain rated as ≥3 (on a 0–10 scale), persisting more than 90 days after rash onset.

    • ZOSTAVAX reduced the incidence of PHN in individuals aged 70 years and older who developed zoster postvaccination.
    • Vaccine efficacy against PHN in subjects who developed zoster postvaccination was 55% (95% CI: 18–76) in individuals aged 70 to 79 years; 5% (95% CI: -107–56; not significant) in individuals aged 60 to 69 years; and 26% (95% CI: -69–68; not significant) in individuals aged 80 years and older.
    The duration of protection beyond 4 years after vaccination with ZOSTAVAX is unknown.
    The need for revaccination has not been defined, but is currently under study.
    Study Design for SPS: Efficacy was evaluated in a placebo-controlled, double-blind clinical trial of ZOSTAVAX. 38,546 subjects aged 60 years or older were randomized to receive a single dose of either ZOSTAVAX (n=19,270) or placebo (n=19,276). Randomization was stratified by age, 60 to 69 and ≥70 years. All patients were monitored for the development of zoster for a median of 3.1 years (range, 31 days to 4.9 years).

About ZOSTAVAX

ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).

Select Safety Information for ZOSTAVAX® (Zoster Vaccine Live)

Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.

Do not administer ZOSTAVAX to individuals who are immunodeficient or immunosuppressed due to disease or therapy, as serious or fatal disseminated vaccine strain varicella-zoster virus disease may occur. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency states, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, and immunosuppressive therapy.

A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.

Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). Common adverse reactions occurring in ≥1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.

Transmission of vaccine virus may occur between vaccinees and susceptible contacts.

Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.

Before administering ZOSTAVAX® (Zoster Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available.

VACC-1133787-0020 05/18