National PBM Criteria for Use

Zoster / Shingles Vaccine (≥ 19,400 PFU / 0.65 ml)^†^

November 2007

VHA Pharmacy Benefits Management Service and the Medical Advisory Panel

*The following recommendations are based on current medical evidence and
expert opinion from clinicians. The content of the document is dynamic
and will be revised as new Centers for Disease Control and Prevention
(CDC) recommendations and clinical data become available. The purpose of
this document is to assist practitioners in clinical decision-making, to
standardize and improve the quality of patient care, and to promote
cost-effective drug prescribing. The clinician should use and interpret
this guidance in the clinical context of the individual patient
situation.*

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| **Inclusion Criteria --- *Patients must meet all of the following     |
| criteria to receive zoster vaccine***                                 |
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| Age 60 years and older and immunocompetent at the time of             |
| vaccination, whether or not the patient reports a prior episode of    |
| chickenpox or herpes zoster (HZ). *For prior physician-diagnosed HZ   |
| rash, see Consider Benefits versus Risks.*                            |
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| Provider has discussed with patient the potential risks and benefits  |
| of vaccination, and the results of the Shingles Prevention Study      |
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| **Consider Benefits Versus Risks**                                    |
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| *Prior physician-diagnosed HZ rash.* Since the duration of            |
| auto-boostering protection from a prior episode of HZ is unknown,     |
| discuss the potential benefits versus risks of zoster vaccine with    |
| individuals who have a prior physician-diagnosed HZ rash. For         |
| example, patients with recent physician-diagnosed HZ rash will likely |
| have adequate natural immunity, less benefit from vaccination, and    |
| unclear risks of harm.                                                |
|                                                                       |
| *HIV infection / AIDS with CD4+ count ≥ 200 cells/µl.* Zoster vaccine |
| is recommended for all indications except pregnancy,                  |
| immunocompromising conditions, and HIV. Zoster vaccine is             |
| specifically *contraindicated* if the CD4+ count is less than         |
| 200 cells/µl.^1^ There is no data on the use of zoster vaccine in     |
| HIV-infected individuals with CD4+ counts ≥ 200 cells/uL.             |
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| **Exclusion Criteria --- *Patients should not receive zoster vaccine  |
| if any of the following criteria are met***                           |
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| *Existing* evidence of non-immunity to chickenpox (e.g., negative     |
| antibody titers)---offer chickenpox vaccine instead (NB: *screening*  |
| for evidence of prior chickenpox is not recommended)                  |
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| Life-threatening disease likely to limit survival to less than 1 year |
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| History of anaphylactic/anaphalactoid reaction to gelatin, neomycin,  |
| or any other component of the vaccine                                 |
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| History of primary or acquired immunodeficiency states including      |
| leukemia; lymphomas of any type, or other malignant neoplasms         |
| affecting the bone marrow or lymphatic system; and human              |
| immunodeficiency virus (HIV) infection / AIDS with CD4+ count less    |
| than 200 cells/µl, or other clinical manifestations of infection with |
| human immunodeficiency viruses. For CD4+ count ≥ 200 cells/µl, see    |
| *Consider Benefits Versus Risks.*                                     |
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| Receiving immunosuppressive therapy, including high-dose              |
| corticosteroids. This includes patients who have received organ       |
| transplants. Consider other patient factors when deciding whether to  |
| vaccinate patients taking 5 to 15 mg of prednisone or equivalent and  |
| no other immunosuppressants.                                          |
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| Active untreated tuberculosis                                         |
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| Pregnant or may be pregnant                                           |
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| Acute febrile illness                                                 |
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| Receiving antiviral therapy that inhibits varicella zoster virus      |
| replication (e.g., acyclovir, valacyclovir, famciclovir, ganciclovir, |
| foscarnet, cidofovir, etc.; however, individuals who have HIV         |
| infection / AIDS with CD4+ count less than 200 cells/µl should NOT    |
| receive zoster vaccine (zoster vaccine is *contraindicated*) and      |
| those with CD4+ count ≥ 200 cells/µl are *neither recommended nor     |
| contraindicated* for zoster vaccine)                                  |
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| **Dosing, Administration, and Storage**                               |
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| One dose (0.65 ml) by subcutaneous injection.                         |
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| Zoster vaccine must be protected from light. It SHOULD BE STORED      |
| FROZEN at an average temperature of ‑15°C (+5°F) or colder until it   |
| is reconstituted for injection. Any freezer, including frost-free,    |
| that has a separate sealed freezer door and reliably maintains an     |
| average temperature of ‑15°C or colder is acceptable for storing      |
| zoster vaccine. THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER  |
| RECONSTITUTION TO MINIMIZE LOSS OF POTENCY. DISCARD RECONSTITUTED     |
| VACCINE IF IT IS NOT USED WITHIN 30 MINUTES. DO NOT FREEZE            |
| reconstituted vaccine.                                                |
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| † Varicella Virus Vaccine Live (Oka / Merck)                          |
|                                                                       |
| 1 MMWR Quick Guide, Recommended Adult Immunization Schedule ---       |
| United States, October 2007 --September 2008, available at:           |
| <http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm#print> |
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