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).

Efficacy in Adults Aged 50 Years or Older

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.

  1. aStudy 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 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
60–69
years64%
70–79
years41%
≥80
years18%
334 cases in the placebo group (n=10,356) vs 122 cases in the ZOSTAVAX group (n=10,370) [95% CI: 56–71] 261 cases in the placebo group (n=7,559) vs 156 cases in the ZOSTAVAX group (n=7,621) [95% CI: 28–52] 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 years51%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.

  1. bStudy 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).

Indication for ZOSTAVAX

ZOSTAVAX® (Zoster Vaccine Live) 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).

Vaccination with ZOSTAVAX® (Zoster Vaccine Live) 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.

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

ZOSTAVAX® (Zoster Vaccine Live) 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).

US-CIN-00011 12/19