CDC Advisory Panel Votes to Recommend Merck's Shingles Vaccine, ZOSTAVAX(R), for Vaccination of Adults Age 60 and Over.

WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that adults 60 years of age and older be vaccinated with ZOSTAVAX[R] [Zoster Vaccine Live (Oka/Merck)] to help prevent shingles (herpes zoster), a frequently painful disease marked by a blistering rash.

ZOSTAVAX was approved by the U.S. Food and Drug Administration (FDA) on May 25 for the prevention of shingles in individuals 60 years of age and older. ZOSTAVAX is not a treatment for shingles or postherpetic neuralgia (long-term nerve pain that can be a complication of shingles). ZOSTAVAX is given by a single dose by injection.

"ZOSTAVAX is the only medical option approved for the prevention of shingles and represents a major public health advance for people age 60 and older," said Mark Feinberg, M.D., Ph.D., vice president of Policy, Public Health and Medical Affairs, Merck Vaccines. "While a number of health plans are already offering insurance coverage of ZOSTAVAX, the panel's recommendation is likely to further increase coverage of the vaccine and further expand access to it among older people in the United States." The ACIP recommendations do not result in requirements for vaccine coverage by insurers; however, private insurers typically follow the Committee's guidance.

The ACIP also considered additional recommendations pertaining to specific uses of the vaccine. Details of the ACIP recommendations for ZOSTAVAX will be available from the CDC. The recommendations are under review by the director of the CDC and the Department of Health and Human Services and will become official when published in the CDC's Morbidity and Mortality Weekly Report.

Anyone who has been infected with chickenpox - that's more than 90 percent of adults in the United States - is at risk for shingles. The risk for shingles increases as people get older. About 40 to 50 percent of the estimated one million cases of shingles that occur each year in the United States occur in people age 60 and older. In people who have had chickenpox, shingles can occur at any time, without warning.

The first signs of shingles are often felt and may not be seen and may include itching, tingling, or burning. A few days later a rash of fluid-filled blisters appears, usually on one side of the body or face. The blisters may take two to four weeks to heal. Shingles can be painful and can cause serious problems. For most people, the pain from the shingles rash lessens as it heals. But for some people, shingles can cause long-term nerve pain, called postherpetic neuralgia or PHN. Long-term nerve pain has been described as burning, stabbing, throbbing, and/or shooting pain. Other problems that may result from shingles include skin infection, muscle weakness, scarring and decrease or loss of vision or hearing.

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.

Vaccination with a live, attenuated vaccine, such as ZOSTAVAX, may result in a more extensive vaccine-associated rash or disseminated disease in individuals who are immunosuppressed. Safety and efficacy of ZOSTAVAX have not been evaluated in individuals on immunosuppressive therapy, nor in individuals receiving daily topical or inhaled corticosteroids or low-dose oral corticosteroids. The use of ZOSTAVAX in individuals with a previous history of shingles has not been studied.

Studies of ZOSTAVAX included more than 40,000 people

ZOSTAVAX was studied in more than 40,000 people, more than 21,000 of whom received the active vaccine. The efficacy and safety of a single dose of ZOSTAVAX was evaluated in the largest of these studies, the landmark Shingles Prevention Study (SPS) of 38,546 men and women 60 years of age and older who had no previous history of shingles. This randomized, double-blind, placebo-controlled study was a Department of Veterans Affairs study conducted in collaboration with the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and Merck at 22 U.S. research sites.

In the study, participants were randomized to groups given either ZOSTAVAX (N=19,270) or a placebo (N=19,276) and followed for the development of shingles for a median duration of 3.1 years. All subjects with clinically diagnosed shingles were offered antiviral treatment, as well as standard-of-care treatment for pain, as necessary.

ZOSTAVAX significantly reduced the risk of developing shingles compared with placebo by 51 percent (315 cases [5.4 cases per 1,000 person-years] vs. 642 cases [11.1 cases per 1,000 person-years], respectively; p<0.001) in the SPS. Efficacy of ZOSTAVAX for the prevention of shingles was highest for those 60 to 69 years of age and declined with increasing age.

Overall, the benefit of ZOSTAVAX in the prevention of long-term nerve pain from shingles (postherpetic neuralgia) can be primarily attributed to the vaccine's effect on the prevention of shingles. Vaccination with ZOSTAVAX reduced the incidence of long-term nerve pain from shingles in individuals 70 years of age and older who were vaccinated with ZOSTAVAX but went on to develop shingles. Following completion of the SPS, a separate analysis was conducted to evaluate the reduction in postherpetic neuralgia in the group of individuals who had been vaccinated with ZOSTAVAX but who had developed shingles. In the analysis, ZOSTAVAX reduced the overall incidence of postherpetic neuralgia by a statistically significant 39 percent compared to the placebo group. A statistically significant reduction in postherpetic neuralgia was seen in individuals aged 70 to 79 (55 percent) and a nonstatistically significant reduction in postherpetic neuralgia was seen in those aged 60 to 69 (5 percent) and 80 and older (26 percent) in the analysis.

Safety Profile of ZOSTAVAX

In the Adverse Event Monitoring Study (AEMS), which included a subgroup of individuals from the SPS, vaccine-related injection site and systemic adverse events seen in the first 42 days after vaccination in one percent or greater of the individuals who received ZOSTAVAX (n=3,345) included headache (1.4 percent) and the following injection-site reactions: erythema (33.7 percent), pain/tenderness (33.4 percent), swelling (24.9 percent), hematoma (1.4 percent), pruritus (6.6 percent), and warmth (1.5 percent). Most of these adverse experiences were reported as mild in intensity.

In the overall study population in the SPS, serious adverse experiences (SAEs) occurred at a similar rate (1.4 percent) in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS, the rate of SAEs was increased in the group who received ZOSTAVAX (1.9 percent) as compared to the placebo group (1.3 percent) in the first 42 days after vaccination. Investigator-determined, vaccine-related serious adverse experiences were reported for two subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and three 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 percent) including coronary artery disease related conditions (0.2 percent) were similar in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS of the SPS, in the first 42 days after vaccination, the rate of overall cardiovascular events was…