CDC Recommends ZOSTAVAX®, Merck's Shingles Vaccine, For All Appropriate Adults Aged 60 And Older

Main Category: Sexual Health / STDs
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 19 May 2008 - 0:00 PST


The U.S. Centers for Disease Control and Prevention (CDC) has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of ZOSTAVAX® (Zoster Vaccine Live) for the prevention of shingles in adults aged 60 and older. ZOSTAVAX is the only vaccine to prevent shingles, a frequently painful disease marked by a blistering rash that is caused by the reactivation of the chickenpox virus. These final vaccination guidelines were published online today in the CDC's Morbidity and Mortality Weekly Report (MMWR) and are now available to health care providers.

ZOSTAVAX is indicated for the prevention of herpes zoster (shingles) in people 60 years of age and older. The ACIP recommendations call for routine vaccination of all appropriate people 60 years of age and older with a single dose of ZOSTAVAX (referred to in the guidelines as zoster vaccine). According to the recommendations, people who report a previous episode of shingles and people with chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease) can be vaccinated unless those conditions or other conditions the person may have are contraindications or precautions. ZOSTAVAX is not indicated for the treatment of shingles or the persistent nerve pain that can follow shingles in some people, called postherpetic neuralgia, or PHN. The recommendations also specify that ZOSTAVAX should not be used to prevent people who have shingles from developing PHN. According to the recommendations, before routine administration of ZOSTAVAX, it is not necessary to ask patients about their history of varicella (chickenpox) or to conduct serologic (blood) tests for varicella immunity. Shingles vaccination is also included on the CDC's 2007-2008 Recommended Adult Immunization Schedule.

"Many adults do not realize that shingles is caused by the same virus that causes chickenpox. Therefore, anyone who has had chickenpox and more than 90 percent of adults in America have is at risk for shingles," said William Schaffner, MD, professor and chairman, Department of Preventive Medicine and professor, Division of Infectious Diseases, Vanderbilt University School of Medicine, and vice president, National Foundation for Infectious Diseases (NFID). "Shingles can be painful. For most people, the pain associated with the shingles rash lessens as the rash heals, but for some adults shingles may lead to pain that can last for months or even years. Health care providers should review this recommendation and discuss the use of ZOSTAVAX for the prevention of shingles with their appropriate patients aged 60 and older."

More than 43 million adults over the age of 60 in the U.S. are estimated to be at risk for shingles. One out of two people who live to age 85 will have had the disease. Yet, according to results from the CDC's 2007 National Immunization Survey, relatively few adults are getting vaccinated against shingles and other potentially serious infectious diseases. Also, earlier this year, the National Foundation of Infectious Diseases (NFID) released a survey showing that, aside from the flu, most adults have trouble naming diseases that they might be able to prevent by getting vaccinated. This NFID survey found that only four percent of adults surveyed were aware that a vaccine can help prevent shingles.

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 a live attenuated varicella-zoster vaccine and administration may result in disseminated disease in individuals who are immunosuppressed. 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.

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

Health care providers should question vaccine recipients about reactions to previous vaccines. Health care providers should also inform vaccine recipients of the benefits and risks of ZOSTAVAX. Patients should be provided with a copy of the Patient Information about ZOSTAVAX, and be given an opportunity to discuss any questions or concerns.

Vaccinees should be informed of the potential risk of transmitting the vaccine virus to varicella-susceptible individuals, including pregnant women who have not had chickenpox.

About Shingles

In people who have had chickenpox, shingles can occur at any time, without warning. The risk for shingles increases as people get older. 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. The rash can be painful, with the pain ranging from mild to severe. 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. This persistent nerve pain has been described as burning, stabbing, throbbing, or shooting pain. Other problems that may result from shingles include skin infection, muscle weakness, scarring, and decrease or loss of vision or hearing. There are approximately one million cases of shingles in the U.S. each year an estimated half of which occur in people 60 years and older.

Access and Reimbursement for ZOSTAVAX

Over 50,000 physicians' offices, pharmacies and public health clinics have ordered ZOSTAVAX since FDA approval. Approximately 3,000 pharmacies are currently participating in the Merck Adult Vaccination Program. This program, designed to help expand access to adult vaccines, including ZOSTAVAX, assists health care providers who want to refer patients to a pharmacy or vaccine service provider location that provides adult vaccinations.

Health plans covering approximately 94 percent of privately-insured lives in the U.S. have approved reimbursement for ZOSTAVAX. Additionally, ZOSTAVAX is eligible for reimbursement under the Medicare Part D prescription drug benefit, and plans covering more than 90 percent of Part D enrollees are reimbursing for ZOSTAVAX. However, individual coverage and reimbursement for privately insured lives and Part D enrollees are subject to the individual's benefit design, including any applicable co-pays, co-insurance and/or deductibles. People 60 and older are encouraged to contact their insurance provider to inquire about their coverage for ZOSTAVAX.

The U.S. Veterans Health Administration makes ZOSTAVAX available to veterans who are patients at VA medical facilities nationwide. Also, TRICARE, the health care plan for the U.S. Department of Defense Military Health System, made ZOSTAVAX a covered medical benefit for plan beneficiaries ages 60 and older. TRICARE administers the health care plan for the uniformed services, retirees and their families.

ZOSTAVAX is part of Merck's Vaccine Patient Assistance Program in the U.S. Through this program, currently available in private physicians' offices and private clinics, Merck makes available, free of charge, ZOSTAVAX and other Merck vaccines indicated for use in eligible individuals ages 19 and older, to people who are uninsured and who are unable to afford vaccines. For more information on the Merck Vaccine Patient Assistance Program, go to www.merckhelps.com.

Selected Important Information about ZOSTAVAX

ZOSTAVAX is a live attenuated virus vaccine 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 PHN.

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 a live attenuated varicella-zoster vaccine and administration may result in disseminated disease in individuals who are immunosuppressed. 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.

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.

Vaccine-related, injection-site and systemic adverse experiences in >1 percent 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 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.

From Day zero to 42 post vaccination, in the overall study population, 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) from Day zero to 42 post vaccination. Over the course of the entire study, in the overall study population, 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).

Among reported serious adverse events in the SPS (Days 0-42 post vaccination), serious cardiovascular events occurred more frequently in subjects who received ZOSTAVAX (20 [0.6 percent]) than in subjects who received placebo (12 [0.4 percent]) in the AEMS. The frequencies of serious cardiovascular events were similar in subjects who received ZOSTAVAX (81 [0.4 percent]) and in subjects who received placebo (72 [0.4 percent]) in the entire SPS study cohort (Days 0 - 42 post vaccination).

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

ZOSTAVAX® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

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