Zoster Vaccine Live
VA Class: IM100
Live, attenuated virus vaccine. Zoster vaccine live contains attenuated varicella zoster virus (VZV) of the Oka/Merck strain and is used to boost active immunity to VZV.
Uses for Zoster Vaccine Live
Prevention of Herpes Zoster
Prevention of herpes zoster (zoster, shingles) in immunocompetent adults ≥50 years of age.
Zoster is caused by reactivation of latent VZV infection in individuals who previously had varicella (chickenpox) infection. An estimated 500,000 to 1 million cases of zoster occur each year in the US; many patients develop postherpetic neuralgia (PHN) and require long-term management for refractory PHN. Risk of developing zoster increases with age and declining cell-mediated immunity to VZV. Zoster occurs principally in individuals >45 years of age; estimated lifetime risk of zoster is ≥32%, and 50% of individuals living until 85 years of age will develop zoster.
Zoster vaccine live is used to boost active immunity to VZV, thereby reducing risk of VZV reactivation. The vaccine may also reduce frequency, severity, and/or duration of PHN in those who develop zoster despite vaccination.
Not indicated for treatment of zoster or PHN. Do not administer during an acute episode of zoster. Has no role in postexposure management of zoster.
Not indicated for prevention of primary varicella infection (chickenpox); do not use in children or adults <50 years of age. Has no role in postexposure management of chickenpox.
There are 2 different types of zoster vaccine commercially available in the US for immunization against zoster in adults ≥50 years of age: zoster vaccine recombinant (RZV; Shingrix) and zoster vaccine live (ZVL; Zostavax).
For prevention of zoster in immunocompetent adults ≥50 years of age, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that zoster vaccine recombinant (not zoster vaccine live) is preferred and can be used in such individuals regardless of history of zoster or prior vaccination with varicella virus vaccine live or zoster vaccine live. The recombinant zoster vaccine also preferred in adults ≥50 years of age with certain chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease).
Although zoster vaccine live is labeled by FDA for use in adults ≥50 years of age, ACIP states that data to date indicate that the duration of protection is uncertain 5 years after vaccination with the live, attenuated vaccine and that adults who receive this vaccine at 50–59 years of age may not be protected when their risks for zoster and its complications are highest. (See Duration of Immunity under Cautions.)
For prevention of zoster in immunocompetent adults ≥60 years of age, ACIP states that either zoster vaccine recombinant or zoster vaccine live can be used.
Zoster Vaccine Live Dosage and Administration
Administer only by sub-Q injection. Do not administer IM or intravascularly.
Be aware that 2 different types of zoster vaccine are commercially available in the US (zoster vaccine recombinant [RZV; Shingrix] and zoster vaccine live [ZVL; Zostavax]). These vaccines have different recommendations for dosage and administration (e.g., different routes of administration, different number of required doses) and different storage requirements.
FDA alerted healthcare professionals about multiple reports of medication errors related to confusion about the 2 different zoster vaccines (e.g., incorrect reconstitution, incorrect route of administration, incorrect interval or number of vaccine doses, inappropriate age of vaccinee, administration after incorrect storage). Follow dosage and administration recommendations for the specific zoster vaccine used.
Administer by sub-Q injection into deltoid region of upper arm.
To ensure appropriate delivery, administer sub-Q injections at a 45° angle using a 5/8-inch, 23- to 25-gauge needle.
Reconstitute and administer using sterile syringes and needles free of preservatives, antiseptics, and detergents to avoid inactivating the live, attenuated virus vaccine.
To maintain potency during storage, lyophilized zoster vaccine must be kept frozen at −50 to −15°C. To minimize loss of potency, reconstitute immediately following removal from the freezer and administer immediately following reconstitution. (See Storage under Stability.)
To reconstitute, add entire contents of the vial containing diluent provided by the manufacturer to the vial of lyophilized vaccine. To avoid excessive foaming, slowly inject diluent into vial of lyophilized vaccine and agitate gently. Use only the diluent supplied by the manufacturer.
Gently agitate reconstituted vaccine to mix thoroughly. Reconstituted vaccine is a semi-hazy to translucent off-white to pale yellow suspension.
Prevention of Herpes Zoster
Adults ≥50 Years of AgeSub-Q
Give zoster vaccine live as a single dose consisting of entire contents (0.65 mL) of a reconstituted single-dose vial.
Duration of protection beyond 4–5 years following the recommended single dose unclear and need for additional (booster) doses of the vaccine not determined. (See Duration of Immunity under Cautions.)
No specific dosage recommendations.
No specific dosage recommendations.
Cautions for Zoster Vaccine Live
History of anaphylactic/anaphylactoid reactions to gelatin, neomycin, or any other vaccine component. (See Sensitivity Reactions under Cautions.)
Immunodeficiency or immunosuppression due to disease or therapy (including, but not limited to, history of primary or acquired immunodeficiency states, acquired immunodeficiency syndrome [AIDS] or other clinical manifestations of HIV infection, leukemia, lymphoma, or other malignant neoplasms affecting the bone marrow or lymphatic system [see Individuals with Altered Immunocompetence under Cautions] and immunosuppressive therapy [see Immunosuppressive Agents under Interactions]).
Pregnancy. (See Pregnancy under Cautions.)
Serious adverse reactions, including anaphylaxis, reported.
Have appropriate medical treatment (e.g., epinephrine) readily available in case an anaphylactic/anaphylactoid reaction occurs.
Contains hydrolyzed porcine gelatin (15.58 mg per dose) as a stabilizer.
Contraindicated in individuals with history of anaphylactic/anaphylactoid reaction to gelatin.
ACIP states that individuals with a history of anaphylactic reaction to gelatin or gelatin-containing products should be evaluated by an allergist prior to receiving a gelatin-containing vaccine.
Contains trace amounts of neomycin.
Neomycin hypersensitivity usually manifests as a delayed-type (cell-mediated) contact dermatitis.
Manufacturer states zoster vaccine live is contraindicated in individuals with a history of anaphylactic/anaphylactoid reaction to neomycin. ACIP states that individuals with a history of anaphylactic reaction to neomycin should be evaluated by an allergist before receiving a neomycin-containing vaccine.
Manufacturer and ACIP state that a history of delayed-type allergic reaction to neomycin is not a contraindication to use of the vaccine.
Individuals with Altered Immunocompetence
Because zoster vaccine live contains live, attenuated virus, it is contraindicated in individuals immunocompromised as the result of disease (e.g., primary or acquired immunodeficiencies, HIV infection, leukemia, lymphoma, other malignancies involving the bone marrow or lymphatic system) or immunosuppressive therapy.
Immune response to the vaccine and efficacy may be reduced in individuals with altered immunocompetence. In addition, use of zoster vaccine live in individuals with altered immunocompetence may result in serious or fatal disseminated VZV disease caused by the vaccine strain. Administration of the vaccine to an immunocompromised patient with chronic lymphocytic leukemia was associated with a fatal disseminated VZV infection complicated by meningoencephalitis.
Although HIV-infected adults (especially those with CD4+ T-cell counts ≤200/mm3) are at increased risk for zoster, zoster vaccine live is contraindicated in such individuals.
When initiation of immunosuppressive therapy anticipated, ACIP and other experts state that administration of a single dose of zoster vaccine live can be considered if the vaccine is administered ≥2–4 weeks prior to initiation of such therapy. (See Immunosuppressive Agents under Interactions.)
ACIP and other experts state that zoster vaccine live can be administered to healthy, immunocompetent adults who reside in households with immunocompromised individuals. However, if vaccinee develops zoster-associated rash, avoid close contact with immunocompromised individuals until lesions resolve.
Transmission of Vaccine Virus
Zoster vaccine live contains live, attenuated VZV. Transmission of vaccine virus may occur between vaccinees and susceptible contacts.
Transmission of zoster vaccine virus has not been documented to date; however, transmission of Oka/Merck strain of VZV has been reported rarely following administration of varicella virus vaccine live, usually only when vaccine recipient developed a varicella-like rash.
Weigh risk of possible vaccine virus transmission against risk of developing natural zoster infection that could be transmitted to susceptible contacts.
Base decision to administer or delay vaccination in an individual with a current or recent acute illness on severity of symptoms and etiology of the illness.
Do not administer zoster vaccine live during an acute episode of herpes zoster (zoster, shingles); defer vaccination until acute stage of the illness is over and symptoms have abated.
Manufacturer states defer zoster vaccine live in patients with active untreated tuberculosis.
Manufacturer suggests that zoster vaccine live be deferred in individuals with acute illness (e.g., in the presence of fever).
ACIP states that mild acute illness generally does not preclude vaccination.
ACIP states that moderate or severe acute illness (with or without fever) is a precaution for vaccination; defer vaccine administration until individual has recovered from the acute phase of the illness. This avoids superimposing vaccine adverse effects on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccine administration.
Limitations of Vaccine Effectiveness
Does not prevent zoster in all vaccine recipients. In vaccinated individuals who develop zoster, duration of pain and discomfort may be reduced.
May be less effective in those ≥70 years of age than in those 60–69 years of age.
Duration of Immunity
Duration of protection against zoster following a single dose of zoster vaccine live and need for revaccination or additional (booster) doses not fully determined.
Data to date indicate the duration of protection is at least 4–5 years, but duration of protection beyond 5 years is uncertain.
Substantial decrease in effectiveness occurs following the first year after vaccination with zoster vaccine live and there is some evidence that efficacy against zoster in vaccinees is <35% by 6 years postvaccination.
Although zoster vaccine live is labeled by FDA for use in adults ≥50 years of age, ACIP states that adults who receive the vaccine at 50–59 years of age may not be protected when their risk for zoster and its complications is highest.
Improper Storage and Handling
Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.
Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained. To maintain potency, lyophilized zoster vaccine live should be stored frozen at −50 to −15°C and used within 30 minutes following reconstitution. (See Storage under Stability.)
Do not administer zoster vaccine that has been mishandled or has not been stored at the recommended temperature.
If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.
Contraindicated during pregnancy; avoid pregnancy for 3 months following administration of the vaccine.
Available data insufficient to assess risks of zoster vaccine live in pregnant women.
Naturally occurring VZV infection during pregnancy can cause fetal harm (i.e., congenital varicella syndrome).
Because theoretical risk for congenital varicella syndrome cannot be ruled out, do not administer to pregnant women.
Inform vaccinees of theoretical risk of transmitting the live, attenuated vaccine virus to varicella-susceptible individuals, including pregnant women who have not had chickenpox. (See Transmission of Vaccine Virus under Cautions.)
Manufacturer states it is not know whether live, attenuated VZV contained in zoster vaccine live is distributed into human milk.
Consider benefits of breast-feeding and importance of zoster vaccine live to the woman along with potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to reactivation of VZV infection).
ACIP states that live, attenuated virus vaccines generally do not pose any unusual risks for women who are breast-feeding or their breast-fed infants. Although live vaccine viruses can replicate in the mother, most live vaccine viruses (including varicella vaccine virus) do not appear to be distributed into milk. Therefore, ACIP states that breast-feeding is not a contraindication for zoster vaccine live.
Not indicated in children and adolescents.
Safety and efficacy established only in adults ≥50 years of age, including geriatric adults. Median age of individuals enrolled in the largest clinical study was 69 years.
Common Adverse Effects
Injection site reactions (erythema, pain/tenderness, swelling, pruritus, warmth, hematoma, induration), headache, extremity pain.
Interactions for Zoster Vaccine Live
Immune responses to vaccines may be reduced in individuals receiving immunosuppressive therapy. In addition, use of zoster vaccine live in individuals receiving immunosuppressive therapy may result in serious and potentially fatal disseminated VZV disease caused by the vaccine strain. Zoster vaccine live contraindicated in individuals receiving immunosuppressive therapy. (See Individuals with Altered Immunocompetence under Cautions.)
Generally give live, attenuated virus vaccines ≥2–4 weeks prior to initiation of immunosuppressive therapy and do not give during or for certain periods of time after immunosuppressive therapy discontinued. (See Specific Drugs under Interactions.)
Concurrent administration with age-appropriate inactivated vaccines or toxoids during the same health-care visit (using separate syringes and different injection sites) generally not expected to affect immunologic responses or adverse reactions to any of the vaccines.
If another parenteral live vaccine is indicated in a patient receiving zoster vaccine live, ACIP states that the vaccines should either be administered on the same day or ≥4 weeks (28 days) apart.
Antiviral agents active against VZV (e.g., acyclovir, famciclovir, valacyclovir)
Data not available to date regarding use of zoster vaccine live in patients receiving antiviral agents active against VZV
Possibility of interference with replication of live, attenuated VZV contained in zoster vaccine live
Discontinue antiviral agents active against VZV ≥24 hours before administration of zoster vaccine live, if possible, and do not give such antivirals until ≥14 days after the vaccine
Blood products (e.g., whole blood, packed RBCs, plasma, platelet products)
May be given concurrently with or at any interval before or after blood or other antibody-containing blood products
Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV], immune globulin sub-Q) or specific hyperimmune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])
May be given concurrently with or at any interval before or after immune globulin or specific hyperimmune globulin
Immunosuppressive agents (e.g., chemotherapy, certain biologic response modifiers, corticosteroids, radiation)
Possible decreased immune responses to vaccines; increased risk of serious and potentially fatal disseminated VZV disease caused by the vaccine virus
Anti-B-cell antibodies (e.g., rituximab): Optimal time to administer vaccines after such treatment unclear
Corticosteroids: High-dose systemic corticosteroid therapy (prednisone or equivalent in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks) considered immunosuppressive; corticosteroid therapy involving short-term (<2 weeks) or low- to moderate-dose systemic therapy (<20 mg prednisone or equivalent daily); long-term, alternate-day systemic therapy using short-acting drugs; maintenance physiologic doses (replacement therapy); topical therapy (e.g., cutaneous, ophthalmic); oral inhalation; or intra-articular, bursal, or tendon injections should not be immunosuppressive
Chemotherapy or radiation: Generally give live, attenuated virus vaccines ≥2–4 weeks before or defer until ≥3 months after such therapy discontinued
Immunosuppressive anti-rejection therapies in solid organ transplant recipients: Defer zoster vaccine live until ≥1 month after such therapies discontinued
Anti-B-cell antibodies (e.g., rituximab): ACIP states give zoster vaccine live ≥2 weeks before or defer until ≥1 month after such therapy; some experts state generally give live, attenuated virus vaccines ≥2–4 weeks before or defer until ≥6 months after such therapy discontinued
Certain biologic response modifiers (e.g., colony-stimulating factors, interleukins, tumor necrosis factor [TNF] blocking agents): Generally give live, attenuated virus vaccines ≥2 weeks before or defer until ≥3 months after such therapy
Corticosteroids: Give zoster vaccine live ≥2 weeks before or defer until ≥1 month after high-dose systemic corticosteroid therapy discontinued; may be given concurrently with or any time before or after lower-dose corticosteroid therapy
Parenteral trivalent inactivated influenza vaccine: Has been given concurrently with zoster vaccine live in adults ≥60 years of age without a decrease in antibody responses
Parenteral quadrivalent inactivated influenza vaccine: Has been given currently with zoster vaccine live in adults ≥50 years of age without a decrease in antibody responses
Parenteral inactivated influenza vaccine: May be given concurrently with zoster vaccine live (using separate syringes and different injection sites)
Pneumococcal 23-valent vaccine (PPSV23; Pneumovax 23): Concurrent administration with zoster vaccine live in adults ≥60 years of age resulted in significantly reduced antibody response to the zoster vaccine compared to administration 4 weeks apart
Manufacturer of zoster vaccine live states consider giving PPSV23 and zoster vaccine live ≥4 weeks apart
For Injection, for Sub-Q Use
To maintain potency during shipment and storage, keep lyophilized zoster vaccine frozen at −50 to −15°C and protect from light.
Any freezer (e.g., frost-free) that reliably maintains an average temperature of −50 to −15°C and has a separate sealed freezer door is acceptable; use of dry ice may expose the vaccine to temperatures colder than −50°C.
When optimal handling conditions are not feasible (e.g., during transportation), the lyophilized vaccine may be stored for ≤72 hours at 2–8°C; discard the refrigerated vaccine if it has not been used within 72 hours after removal from storage at −50 to −15°C.
Store vial containing the diluent supplied by the manufacturer separately either at room temperature (20–25°C) or in a refrigerator (2–8°C).
Contact the manufacturer at 800-637-2590 for information regarding vaccine stability under conditions other than those recommended.
Use immediately following reconstitution; discard reconstituted vaccine if not used within 30 minutes. Do not freeze.
Zoster vaccine does not contain thimerosal or any other preservatives.
Zoster vaccine is a lyophilized preparation containing live, attenuated VZV of the Oka/Merck strain.
Contains same antigen as varicella virus vaccine live (Varivax); however, zoster vaccine live is about 14 times more potent than varicella virus vaccine live. The higher potency of varicella antigen contained in zoster vaccine live is required to elicit a clinically important increase in cell-mediated immunity to VZV in older adults.
Vaccination with a single dose of zoster vaccine live boosts active immunity to VZV, thereby reducing reactivation of VZV and development of zoster and complications of the disease.
Herpes zoster (zoster, shingles) and varicella (chickenpox) are distinct clinical entities caused by the same virus, VZV. During primary infection, VZV causes chickenpox; the virus invades sensory neurons and becomes latent in sensory nerve ganglia, establishing a source of potential secondary infection.
Zoster is characterized by unilateral, painful, vesicular cutaneous eruption with a dermatomal distribution. Pain may occur during the prodrome, the acute eruptive phase, and the postherpetic phase of the infection (PHN). Serious complications of the disease (e.g., scarring, bacterial superinfection, allodynia, cranial and motor neuron palsies, pneumonia, encephalitis, visual impairment, hearing loss, death) may occur.
A single dose of zoster vaccine live boosts VZV antibody levels 2.3-fold in adults 50–59 years of age or 1.7-fold in adults ≥60 years of age.
Minimum antibody titer that correlates with protection against zoster not established.
Advice to Patients
Provide copy of manufacturer’s patient information. Also provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at [Web]).
Advise patient of the risks and benefits of vaccination with zoster vaccine live.
Advise patient that zoster vaccine live is used to prevent zoster (shingles) and cannot be used to treat shingles once the condition develops. Also advise patient that the vaccine is not used to prevent primary varicella infection (chickenpox).
Advise patient that zoster vaccine may not provide protection against zoster (shingles) in all vaccinees.
Advise patient that they should not receive zoster vaccine live if they have a history of anaphylactic/anaphylactoid reactions to any of its ingredients (e.g., gelatin, neomycin).
Advise patient that they should not receive zoster vaccine live if they have a disease that weakens the immune system (e.g., HIV/AIDS, leukemia, lymphoma) or are receiving treatment that may weaken the immune system (e.g., high-dose corticosteroids).
Advise patient of the theoretical risk of transmitting the vaccine virus to varicella-susceptible individuals, including immunosuppressed or immunodeficient individuals or pregnant women who have not had chickenpox. Importance of informing clinician if they expect to be in close contact with individuals with weakened immune systems, neonates, or pregnant women who have not had chickenpox or have not been vaccinated against chickenpox.
Importance of contacting clinicians if an adverse reaction or hypersensitivity reaction (e.g., difficulty breathing or swallowing) occurs following the vaccine dose. Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
For injectable suspension, for subcutaneous use
≥19,400 plaque-forming units (PFU) of Oka/Merck strain of varicella zoster virus per 0.65 mL
AHFS DI Essentials™. © Copyright 2021, Selected Revisions November 26, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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