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).

ZOSTAVAX has a Demonstrated Safety Profile

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
  ZOSTAVAX (n=11,094) % PLACEBO (n=11,116) %
Pain 53.9 9.0
Erythema 48.1 4.3
Swelling 40.4 2.8
UNSOLICITED
  ZOSTAVAX (n=11,094) % PLACEBO (n=11,116) %
Pruritus 11.3 0.7
Warmth 3.7 0.2
Hematoma 1.6 1.6
Induration 1.1 0.0
  1. 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

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
  ZOSTAVAX (n=3,345) % PLACEBO (n=3,271) %
Erythema 35.6 6.9
Pain/Tenderness 34.3 8.3
Swelling 26.1 4.5
UNSOLICITED
  ZOSTAVAX (n=3,345) % PLACEBO (n=3,271) %
Hematoma 1.6 1.4
Pruritus 6.9 1.0
Warmth 1.6 0.3
  1. 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).

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