Vaccine efficacy for the prevention of herpes zoster was highest for those subjects 60 to 69 years of age and declined with increasing age.

ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia.

The duration of protection beyond 4 years after vaccination with ZOSTAVAX
is unknown. The need for revaccination has not been defined.

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

ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).

Shingles Prevention Study (SPS) Design

^bEfficacy was evaluated in the Shingles Prevention Study (SPS), a placebo-controlled, double-blind clinical trial of ZOSTAVAX. 38,546 subjects 60 years of age or older were randomized to receive a single dose of either ZOSTAVAX (n=19,270) or placebo (n=19,276) and were monitored for the development of zoster for a median of 3.1 years (range, 31 days to 4.90 years).

The study excluded people who were immunocompromised or using corticosteroids on a regular basis, anyone with a previous history of herpes zoster, and those with conditions that might interfere with study evaluations, including people with cognitive impairment, severe hearing loss, those who were non-ambulatory, and those whose survival was not considered to be at least 5 years.

Select Safety Information

ZOSTAVAX is contraindicated in persons with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; with a history of primary or acquired immunodeficiency states including leukemia; lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; or with AIDS or other clinical manifestations of infection with human immunodeficiency viruses. ZOSTAVAX is also contraindicated in persons on immunosuppressive therapy. ZOSTAVAX is not indicated in women of childbearing age and should not be administered to pregnant females.

Vaccine-related, injection-site and systemic adverse events in >1% of individuals in the Adverse Event Monitoring Substudy (AEMS), a subgroup of individuals from the Shingles Prevention Study (SPS) who received ZOSTAVAX (n=3,345), included headache (1.4%) and the following injection-site reactions: erythema (33.7%), pain/tenderness (33.4%), swelling (24.9%), hematoma (1.4%), pruritus (6.6%), and warmth (1.5%). Most of these adverse experiences were reported as mild in intensity.

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, 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 serious adverse experiences 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 serious adverse events in the SPS (Days 0–42 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. 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 study cohort (Days 0–42 postvaccination).

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

ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).

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

Before administering ZOSTAVAX, please read the Prescribing Information and Patient Product Information.

ZOSTAVAX is a registered trademark of Merck & Co., Inc.