Vaccines and Preventable Diseases:

Herpes Zoster - Vaccine Q&As for Providers
(Shingles)

General Questions about Shingles (From Chickenpox Virus)

What is the treatment for shingles?

Several antiviral drugs are available for the treatment of shingles: acyclovir (Zovirax®), valacyclovir (Valtrex®), and famciclovir (Famvir®). Treatment will shorten the duration and severity of illness but will not prevent the development of PHN. Treatments should be initiated within 24 hours of rash onset. Medication can reduce the pain associated with shingles.

Is there a vaccine to prevent shingles?

Yes. Zostavax®, a live virus zoster (shingles) vaccine, is recommended for use in persons 60 years old or older to prevent shingles.

What are the specific indications for using the vaccine?

The Advisory Committee for Immunization Practices (ACIP) recommends a single dose of zoster (shingles) vaccine for adults 60 years old or older, whether or not the patient reported a prior episode of shingles. Persons with chronic medical conditions may be vaccinated unless a contraindication or precaution exists for their condition.

Who should NOT get the vaccine?

Zostavax® should NOT be administered to individuals

• with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; Zostavax Package Insert (10 pages) (exit)
• with a history of primary or acquired immunodeficiency state, including leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic system, or with acquired immunodeficiency syndrome or other clinical manifestation of infection with human immunodeficiency viruses;
• receiving immunosuppressive therapy, including high-dose corticosteroids;
• with active, untreated tuberculosis; or
• who are or may be pregnant.

How effective is the vaccine?

In a clinical trial involving more than 38,000 adults 60 years of age or older, the vaccine reduced the overall incidence of shingles by 51% and the incidence of PHN by 67%. The efficacy of the vaccine in preventing shingles was higher in the younger age group (60-69 years; vaccine efficacy was 64%) than in the older age group (older than 70 years; vaccine efficacy was 38%).

What are the side effects of the vaccine?

In a clinical trial involving more than 38,000 adults, Zostavax® was administered to about half of the study participants. The other half received a placebo. The prevalence of serious adverse events was similar in the vaccine and placebo groups (1.9% and 1.3%, respectively). One case of anaphylaxis occurred in the placebo group. No vaccine-related deaths were reported. The most commonly reported side effects were erythema (36%), pain or tenderness (35%), swelling (26%), and pruritis (7%) at the injection site.

What should you do if you think a patient has had a serious reaction to the vaccine?

Immediately report the incident to the Vaccine Adverse Event Reporting System, which is maintained jointly by CDC and FDA. The phone number is 800-822-7967, and the web site address is www.vaers.hhs.gov (exit)

Can the zoster (shingles) vaccine be administered with other vaccines?

Yes. Zostavax® is a live virus vaccine. It can be administered concurrently with all other live and inactivated vaccines, including those routinely recommended for persons in 60 years and older age group, such as influenza and pneumococcal vaccines.

Should the zoster (shingles) vaccine be given to people who have already had shingles?

Yes, it should be given regardless of a history of shingles. Shingles does recur, and there is no biological or epidemiological evidence to indicate that persons are at reduced risk for shingles for any period of time following a prior episode of shingles. Furthermore, while shingles is a distinct condition, errors in diagnosis occur. Finally, patients often report prior, self-diagnosed episodes of shingles, but the likelihood of misdiagnosis in these cases is high. Since there is no way to confirm a history of shingles, exclusion of patients with reports of prior episodes of shingles would pose a large burden on physicians for assessing the nature of the prior diagnosis and to judge its reliability. This would introduce a large barrier to vaccination. Since there are no recognized safety concerns in giving the vaccine to persons with prior shingles, the vaccine should be made available to persons regardless of prior shingles history.

Should the zoster (shingles) vaccine be given to people whose history of having had varicella disease (chickenpox) is unclear (i.e., they are not sure they had chickenpox)?

Yes, the zoster (shingles) vaccine should be given to people who are not sure if they have had chickenpox. On the basis of data from the National Health and Nutrition Examination Survey (NHANES 1988-1994), it is estimated that 98% of adults 20 years old or older in the United States have serologic evidence of VZV infection.

When conducting routine zoster (shingles) vaccination of persons 60 years of age or older, there is no need to verbally screen for a history chickenpox infection or to conduct laboratory testing for serologic evidence of prior varicella infection. Furthermore, if a person reports a negative history of varicella, they can still receive the zoster (shingles) vaccine. The zoster (shingles) vaccine package insert makes no reference to varicella history, and almost all persons 60 years old or older are immune to varicella. This is the basis for ACIP criteria for varicella immunity, which state that persons born in the United States prior to 1980 are considered immune to varicella. However, if a physician chooses to screen all adult patients (for the purposes of varicella vaccination), they should inquire about the patient’s birth country and their varicella history, and if they are foreign born, their varicella antibody levels should be checked, if indicated. If, through this screening process or any other process, serologic evidence of varicella susceptibility becomes available to the physician, the patient should be offered varicella vaccine (against chickenpox) not zoster (shingles) vaccine (against shingles).

Is the zoster (shingles) vaccine effective treatment for shingles?

No. There are no comprehensive data on the effectiveness of zoster (shingles) vaccine in treating shingles once it occurs, and the vaccine is not licensed for this indication.

Should the zoster (shingles) vaccine be given to a person who comes in contact with a person with shingles?

Shingles results from the reactivation of VZV in a person with a history of varicella (chickenpox) infection. While the process of VZV reactivation is poorly understood, there is no evidence that exposure of a person with a history of varicella infection to exogenous VZV, that is, to a person with either shingles or chickenpox, should result in shingles. A person who has no immunity to varicella (i.e., never had chickenpox and never received varicella vaccine) and who has close exposure to someone with shingles is at risk for developing varicella infection. In this case, recommendations for the prevention of varicella should be followed.

Can someone who was recently vaccinated with the zoster (shingles) vaccine transmit the vaccine-associated VZV virus to someone else?

Transmission of the zoster (shingles) vaccine-associated virus has never been documented.

Are booster doses of vaccine recommended?

Currently, only one dose of zoster (shingles) vaccine is recommended. Studies are ongoing to assess the duration of protection from one dose of zoster (shingles) vaccine and the need, if any, for booster doses.

What is the difference between Zostavax® and Varivax®?

Zostavax®, the vaccine to prevent shingles, consists of attenuated (Oka-strain) varicella virus at a concentration at least 14 times that found in Varivax®, the vaccine to prevent varicella (chickenpox). Zostavax® cannot be used in children and cannot be used in place of varicella vaccine. Varivax® cannot be used in place of Zostavax®.

Can the currently licensed varicella (chickenpox) vaccine be use to prevent shingles?

No. Varicella vaccine is NOT licensed for the prevention of shingles. Zostavax® should not be administered to children in place of varicella vaccine (Varivax®).

Can the shingles vaccine be used in children?

No. Zostavax® should not be used in children and is not a substitute for the varicella (chickenpox) vaccine.

How is the vaccine supplied?

The vaccine is supplied as single-dose vials, packaged either individually or in packages of 10. The vaccine is lyophilized and is supplied with diluent. It does not contain thimerosal. The vaccine must be kept frozen during transport and storage (see below).

How is the zoster (shingles) vaccine stored?

The vaccine should be stored frozen at an average temperature of +5°F (-15°C) until it is reconstituted. The diluent should be stored separately at room temperature (68-77°F, 20-25°C) or in the refrigerator (35-46°F, 2-8°C). To maintain freezer temperatures of 5°F (-15°C) or colder, it will be necessary in most refrigerator/freezer models to turn the temperature dial to the coldest setting. This may result in lower temperatures in the refrigerator compartment as well. Careful monitoring of the refrigerator temperature will be necessary to avoid exposing killed or inactivated vaccines that are stored between 35°F and 46°F (2-8°C) to freezing temperatures. To prevent this from happening, both the refrigerator and freezer temperatures should be checked and recorded at least twice a day. For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90 (1-800-637-2590).

How is the vaccine prepared for administration?

The vaccine should be administered immediately after reconstitution to minimize loss of potency. Any unused vaccine should be discarded if not used within 30 minutes.

How is the vaccine administered?

The vaccine is administered subcutaneously as a single dose.

Does the vaccine contain thimerosal?

No, the vaccine does not contain thimerosal.

Will zoster (shingles) vaccine be covered by Medicare for Medicare beneficiaries?

While details are evolving, it is anticipated that zoster (shingles) vaccine will not be covered under Medicare part B (which covers influenza and pneumococcal polysaccharide vaccine as well as hepatitis B for moderate and high risk persons). The vaccine will instead be reimbursed through the Medicare Part D program. Beneficiaries should contact their Part D plan for more information.

REFERENCES

Gnann JW and Whitely RJ. Herpes Zoster. New Engl J Med 2002;347:340-6.

Oxman MN , et al. A Vaccine to Prevent Herpes Zoster and PHN in Older Adults. New Engl J Med 2005.352:2271-84.

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