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.

ZOSTAVAX has a demonstrated safety profile

  • In patients aged 50 to 59 years
    In patients aged 50 to 59 years
    In ZOSTAVAX Efficacy and Safety Trial (ZEST), the overall incidence of vaccine-related injection-site adverse reactions within 5 days postvaccination was greater for subjects vaccinated with ZOSTAVAX as compared to subjects who received placebo (63.6% for ZOSTAVAX and 14.0% for placebo).
    Injection-site adverse reactions reported in ≥1% of adults who received
    ZOSTAVAX or placebo within 5 days postvaccination in ZEST
    ADVERSE
    REACTION
    SOLICITEDa UNSOLICITED
    Pain Erythema Swelling Pruritus Warmth Hematoma Induration
    ZOSTAVAX
    (n=11,094) %
    53.9 48.1 40.4 11.3 3.7 1.6 1.1
    PLACEBO
    (n=11,116) %
    9.0 4.3 2.8 0.7 0.2 1.6 0.0
    Injection-site reactionsa in ≥1% of adults who received ZOSTAVAX or placebo within 5 days postvaccination from the AEMS of the SPS
    ADVERSE
    REACTION
    SOLICITEDb
    Erythema Pain/Tenderness Swelling
    ZOSTAVAX
    (n=3,345) %
    35.6 34.3 26.1
    PLACEBO
    (n=3,271) %
    6.9 8.3 4.5
    ADVERSE
    REACTION
    UNSOLICITED
    Hematoma Pruritus Warmth
    ZOSTAVAX
    (n=3,345) %
    1.6 6.9 1.6
    PLACEBO
    (n=3,271) %
    1.4 1.0 0.3
    Injection-site adverse reactions reported in ≥1% of adults who received ZOSTAVAX or placebo within 5 days postvaccination in ZEST
      ADVERSE
    REACTION
    ZOSTAVAX

    (n=11,094)%

    PLACEBO

    (n=11,116)%

    Pain 53.9 9.0
    Erythema 48.1 4.3
    Swelling 40.4 2.8
    Pruritus 11.3 0.7
    Warmth 3.7 0.2
    Hematoma 1.6 1.6
    Induration 1.1 0.0
    aSolicited on the Vaccination Report Card (VRC).
    Adequate treatment provisions, including epinephrine injection (1:1,000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.
    Systemic Adverse Reactions
    Systemic adverse reactions and experiences reported during Days 1 to 42 at an incidence of ≥1% in either vaccination group were headache (ZOSTAVAX 9.4%, placebo 8.2%) and pain in the extremity (ZOSTAVAX 1.3%, placebo 0.8%), respectively.
    The overall incidence of systemic adverse experiences reported during Days 1 to 42 was higher for ZOSTAVAX (35.4%) than for placebo (33.5%).
    Serious Adverse Events
    In ZEST, serious adverse events occurred at a similar rate in subjects vaccinated with ZOSTAVAX (0.6%) or placebo (0.5%) from Days 1 to 42 postvaccination.
    In ZEST, an anaphylactic reaction was reported for one subject vaccinated with ZOSTAVAX.
  • In patients aged ≥60 years
    In patients aged ≥60 years
    The Adverse Event Monitoring Substudy (AEMS) of the Shingles Prevention Study (SPS), designed to provide detailed data on the safety profile of the zoster vaccine, used vaccination report cards (VRC) to record adverse events occurring from Days 0 to 42 postvaccination.
    Injection-site reactionsb in ≥1% of adults who received
    ZOSTAVAX or placebo within 5 days postvaccination from the AEMS of the SPS
    ADVERSE
    REACTION
    SOLICITEDc UNSOLICITED
    Erythema Pain/Tenderness Swelling Hematoma Pruritus Warmth
    ZOSTAVAX
    (n=3,345) %
    35.6 34.3 26.1 1.6 6.9 1.6
    PLACEBO
    (n=3,271) %
    6.9 8.3 4.5 1.4 1.0 0.3
    Injection-site reactionsb in ≥1% of adults who received ZOSTAVAX or placebo within 5 days postvaccination from the AEMS of the SPS
      ADVERSE
    REACTION
    ZOSTAVAX

    (n=3,345)%

    PLACEBO

    (n=3,271)%

    Erythema 35.6 6.9
    Pain/Tenderness 34.3 8.3
    Swelling 26.1 4.5
    Swelling 1.6 1.4
    Pruritus 6.9 1.0
    Warmth 1.6 0.3
    bPatients instructed to report adverse experiences on the VRC.
    cSolicited on the VRC.
    Most injection-site adverse reactions were reported as mild in intensity.
    Systemic Adverse Reactions
    Headache was the only systemic adverse reaction reported on the VRC between Days 0 to 42 by ≥1% of subjects in the AEMS in either vaccination group (ZOSTAVAX 1.4%, placebo 0.8%).
    Serious Adverse Events
    From Day 0 to 42 postvaccination, in the overall study population, serious adverse experiences (SAEs) occurred at a similar rate (1.4%) in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS,b the rate of SAEs was increased in the group who received ZOSTAVAX (1.9%) as compared to the placebo group (1.3%) from Day 0 to 42 postvaccination.
    Over the course of the entire study, in the overall study population, investigator-determined, vaccine-related SAEs were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).
    • Among reported SAEs in the SPS (Days 0 to 42 postvaccination), serious cardiovascular events occurred more frequently in subjects who received ZOSTAVAX (20 [0.6%]) than in subjects who received placebo (12 [0.4%]) in the AEMS.b
    • The frequencies of serious cardiovascular events were similar in subjects who received ZOSTAVAX (81 [0.4%]) and in subjects who received placebo (72 [0.4%]) in the entire SPS cohort (Days 0 to 42 postvaccination).

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