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and related fields, develops written recommendations for the routine administration of vaccines.

ZOSTAVAX was approved by the US Food and Drug Administration (FDA) on May 25, 2006.

ZOSTAVAX is indicated for prevention of herpes zoster (shingles) in individuals 60 years of age

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

ZOSTAVAX is given as a single dose by subcutaneous injection. The use of ZOSTAVAX in

individuals with a previous history of zoster has not been studied.

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; with AIDS or other clinical

manifestations of infection with human immunodeficiency viruses; and with active untreated

tuberculosis. ZOSTAVAX is also contraindicated in persons on immunosuppressive therapy,

including high-dose corticosteroids, and in women who are or may be pregnant.

ZOSTAVAX is a live attenuated vaccine. There is a theoretical risk of transmitting the vaccine

virus to close contacts who are varicella-susceptible, including those who have problems with

their immune system or are pregnant.

ZOSTAVAX is not a substitute for VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and

should not be used in children.

Event Monitoring Substudy (AEMS), a subgroup of individuals from the Shingles Prevention

Study who received ZOSTAVAX (n=3,345), included headache (1.4%) and the following injectionsite

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.

Merck & Co., Inc.

In the overall study population, serious adverse experiences (SAEs) occurred at a similar rate

(1.4%) in subjects vaccinated with ZOSTAVAX® [Zoster Vaccine Live (Oka/Merck)] 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 0–42 postvaccination. 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).

In the entire SPS study population, the rates of overall cardiovascular events (0.4%) including

coronary artery disease-related conditions (0.2%) were similar in subjects vaccinated with

ZOSTAVAX or placebo. In the AEMS of the SPS, between Day 0–42 postvaccination, the rate of

overall cardiovascular events was higher after ZOSTAVAX (0.6%) than after placebo (0.4%),

including the rate of coronary artery disease-related conditions (ZOSTAVAX 0.3%; placebo

0.2%).

As with any vaccine, vaccination with ZOSTAVAX may not result in protection of all vaccine

recipients.

ZOSTAVAX may be ordered in 1 single-dose vial of lyophilized vaccine, NDC code 0006-4963-

00, and in boxes of 10 single-dose vials of lyophilized vaccine, NDC code 0006-4963-41.

To place an order, or for more information about ZOSTAVAX, contact your Merck sales

representative, your vaccine distributor, visit www.merckvaccines.com, or call 1-800-MERCK-90

(1-800-637-2590).

Before administering ZOSTAVAX, please read the accompanying Prescribing Information.

Sincerely,

Steven R. Vignau

Vice President, Marketing

Merck Vaccine Division

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Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company... more