Merck & Co., Inc. announced 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? [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 higher after ZOSTAVAX (0.6 percent) than after placebo (0.4 percent), including the rate of coronary artery disease-related conditions (ZOSTAVAX, 0.3 percent; placebo, 0.2 percent).
Selected Important Information about ZOSTAVAX
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.
As with any vaccine, vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.
The duration of protection after vaccination with ZOSTAVAX is unknown. In the SPS, protection with ZOSTAVAX was demonstrated through four years of follow-up. The need for revaccination has not been defined.
Concurrent administration of ZOSTAVAX and antiviral medications known to be effective against the varicella zoster virus has not been evaluated. Concurrent administration of ZOSTAVAX and other vaccines has not been evaluated.
About the Advisory Committee on Immunization Practices (ACIP)
The ACIP develops written recommendations for the routine administration of vaccines, along with schedules regarding the appropriate dosage and dosing frequency, and contraindications applicable to the vaccines.
The goals of the Committee, which consists of 15 experts in immunization and related fields, are to provide advice which will assist the CDC and the nation in reducing the incidence of vaccine-preventable diseases and to increase the safe usage of vaccines and related biological products.
Availability of ZOSTAVAX
Merck makes ZOSTAVAX, as well as its other adult vaccines, available free of charge through a U.S. patient assistance program for low-income individuals for whom the vaccines are medically appropriate. Through this program, Merck provides free vaccines to adults who are uninsured and who are unable to afford vaccines. Merck’s adult vaccines became available through this program in September. For more information on the Merck Adult Vaccines Patient Assistance Program, go to www.merckhelps.com.
Outside the United States, ZOSTAVAX was approved for licensure in the European Union and in Australia in May of this year, and Merck has filed regulatory applications for ZOSTAVAX in other world markets. Merck plans to begin to commercialize ZOSTAVAX outside of the United States in 2007.
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 www.merck.com.
ZOSTAVAX? is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.