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Herpes Zoster Vaccination

Information for Health Care Professionals

Vaccine Composition, Dosage, and Administration

Zostavax®, the vaccine to prevent herpes zoster (also referred to as shingles or zoster), 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. Zostavax should not be used in children and is not a substitute for the varicella vaccine.

The vaccine is administered subcutaneously as a single dose. The vaccine should not be injected intramuscularly. However, it is not necessary to repeat vaccination if the shingles vaccine is administered intramuscularly.

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.

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Vaccine Efficacy

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%).

Studies are ongoing to assess the duration of protection from one dose of zoster vaccine and the need, if any, for booster doses.

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

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Recommendations

Routine vaccination of persons aged ≥ 60 years

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.

When conducting routine zoster 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 not zoster vaccine.

Groups NOT recommended for vaccination

Zostavax should NOT be administered to individuals

  • 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 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; or
  • who are or may be pregnant.

Simultaneous administration with other vaccines

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.

Of note, in December 2009 Merck revised the package insert for herpes zoster vaccine (HZV) to advise that HZV and 23-valent pneumococcal polysaccharide vaccine (PPSV) should not be administered concurrently. This recommendation was based on a Merck study that showed the average titer against varicella zoster virus (VZV) was lower in persons who received zoster and PPSV at the same visit compared to persons who received these vaccines 4 weeks apart. However, the clinical relevance of this observation is unknown because there is no evidence to indicate that antibody titers against VZV are a measure of protection against HZ (results were additionally confounded by unexplained differences across comparison group in the baseline VZV antibody titers). In fact, a large study was subsequently conducted that showed that zoster vaccine was equally effective at preventing herpes zoster whether it was administered simultaneously with PPSV or 4 weeks earlier. Also, the safety profile of zoster vaccine is unaffected by simultaneous administration of PPSV. Consequently, to avoid introducing barriers to patients and providers who are interested in these two important vaccines, CDC has not changed its recommendation for either vaccine, and continues to recommend that HZV and PPSV be administered at the same visit if the person is eligible for both vaccines.

Vaccination of those with prior history of zoster

Zoster vaccine 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.

The general guideline for any vaccine is to wait until the acute stage of the illness is over and symptoms abate.

Vaccination of persons age 50 through 59 years

In 2011, FDA expanded the age indication for Zostavax® to include adults 50 through 59 years old for preventing herpes zoster. This decision was based on a large study showing that the vaccine reduced the risk of herpes zoster by approximately 70 percent.

For persons age 50 through 59 years, the risk of getting shingles and having prolonged pain after shingles is much lower than for people 60 years and older. In the past several years, there have been shortages and delays in getting Zostavax®. Based on such considerations, ACIP is not issuing a recommendation for routine use of zoster vaccine in adults 50 through 59 years at this time. However, health care providers can still offer herpes zoster vaccine to patients 50 through 59 years. Health care providers may want to first consider whether the patient would have poor tolerance to herpes zoster or postherpetic neuralgia symptoms. For example, if the patient has

  • preexisting chronic pain, severe depression, or other co-morbidities
  • intolerance to treatment medications due to hypersensitivity or interactions with other medications
  • extenuating employment-related factors

No data are available about the effectiveness of zoster vaccine in adults who become immunosuppressed after their vaccination.

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Vaccine Safety and Monitoring

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.

Transmission of the zoster (shingles) vaccine-associated virus has never been documented. Persons having close household or occupational contact with persons at risk for severe varicella need not take any precautions after receiving zoster vaccine except in rare instances in which a varicella-like rash develops, when standard contact precautions are adequate. Although transmission of Oka/Merck strain VZV has been documented following varicella vaccination, such transmission is rare and has only been documented when the vaccine recipient first developed a varicella-like rash. Rates of varicella-like rash appear to be less common following zoster vaccination than following varicella vaccination, and transmission of the Oka/Merck strain VZV from recipients of zoster vaccine has not been detected.

If an adverse event occurs following vaccination in a patient vaccinated with zoster 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 http://www.vaers.hhs.gov.

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Vaccine Administration Errors

If zoster vaccine is accidentally given to a child who was supposed to be vaccinated with varicella vaccine, this is a serious vaccine administration error. The event should be documented and procedures put in place to prevent this from happening again. This event should be reported 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 http://www.vaers.hhs.gov.

Zoster vaccine, when reconstituted as directed on the package label using the supplied diluent, contains a minimum of 19,400 PFU of Oka/Merck strain of varicella zoster virus. Its minimum potency is at least 14-times the potency of Varivax, which contains a minimum of 1,350 PFU, and is similar in potency to the VZV content of Proguad®.

If a dose of zoster vaccine (Zostavax) was given accidentally in place of the varicella vaccine (Varivax), then that dose of zoster vaccine should be counted the same as a single valid dose of varicella vaccine since the level of protection against varicella would probably be at least the same as for the conventional doses of varicella vaccine. If the erroneous dose was administered in lieu of the first dose of varicella vaccine, a second dose of varicella vaccine is required.

In the event that varicella vaccine was accidentally administered to an adult age 60 years and older instead of zoster vaccine, ACIP states

"If a provider mistakenly administers varicella vaccine to a person for whom zoster vaccine is indicated, no specific safety concerns exist, but the dose should not be considered valid and the patient should be administered a dose of zoster vaccine during that same visit. If the error is not immediately detected, a dose of zoster vaccine should be administered as soon as possible but not within 28 days of the varicella vaccine dose to prevent potential interference of 2 doses of live attenuated virus."

The event should be documented and procedures put in place to prevent this from happening again.

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Vaccine Storage and Handling

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Rationale for herpes zoster vaccination

Herpes zoster is a burden to the public's health.

  • There are an estimated one million cases of herpes zoster in the United States each year.
  • Pain and suffering from herpes zoster is greatest for elderly people who are often least able to access medical care or tolerate the medications used to manage the symptoms.
  • An estimated $1 billion is spent annually on direct medical care costs for herpes zoster in the United States.

Treatment for herpes zoster is not always effective or available.

  • People should start antiviral treatment within 72 hours of rash onset in order to get the most benefit. However, many patients do not get diagnosed right away and miss this window of opportunity.
  • Treatment is only partially effective at relieving and shortening the duration of symptoms.

Herpes zoster vaccine is effective at preventing herpes zoster and its complications.

  • The Shingles Prevention Study, a pre-licensure study of 38,546 people, showed that herpes zoster vaccine reduced the incidence of herpes zoster by 51% and PHN by 66.5%.

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