Zoster Vaccine (Live/Attenuated)
Medically reviewed by Drugs.com. Last updated on Jun 8, 2020.
(ZOS ter vak SEEN live ah TEN yoo aye ted)
- Herpes Zoster Vaccine
- Shingles Vaccine
- VZV Vaccine (Zoster)
- Zoster Vaccine Live
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension Reconstituted, Subcutaneous [preservative free]:
Zostavax: 19,400 units/0.65 mL (1 ea [DSC]) [contains albumin bovine, beef extract (bovine), gelatin (pork), neomycin]
Brand Names: U.S.
- Zostavax [DSC]
- Vaccine, Live (Viral)
A decline in VZV-specific immunity increases the risk of developing zoster infection. As a live, attenuated vaccine (Oka/Merck strain of varicella-zoster virus), zoster virus vaccine stimulates active immunity to disease caused by the varicella-zoster virus. Administration has been demonstrated to protect against the development of herpes zoster. It may also reduce the severity of complications, including postherpetic neuralgia, in patients who develop zoster following vaccination.
Zoster vaccine live reduced the incidence of zoster by ~70% in those 50 to 59 years of age, 64% in those 60-69 years of age, and 38% in those ≥70 years of age (CDC/ACIP [Dooling 2018]). Additional benefit was afforded to vaccine recipients who developed zoster by reduction in the incidence of PHN: 5% for those 60-69 years of age, 55% for those 70-79 years of age, and 26% for those 80 years and older. Other prespecified zoster-related complications were reported less frequently in subjects who received zoster vaccine compared with subjects who received placebo.
Onset of Action
Seroconversion: ~6 weeks (CDC/ACIP [Harpaz, 2008])
Duration of Action
Duration of protection decreases over time with substantial decrease after 1 year. Effectiveness of ZVL in preventing herpes zoster decreased to 32% after 8 years in individuals ≥50 years (Baxter 2017; CDC/ACIP [Dooling 2018]).
Use: Labeled Indications
Herpes zoster prevention: Prevention of herpes zoster (shingles) in patients ≥50 years of age
The Advisory Committee on Immunization Practices (ACIP) recommends zoster vaccine for the prevention of herpes zoster and related complications in immunocompetent adults. Recombinant zoster vaccine (RZV) is preferred for adults ≥50 years. However, zoster vaccine live (ZVL) remains an option for immunocompetent adults ≥60 years (CDC/ACIP [Dooling 2018]).
Limitations of use: Not indicated for treatment of active herpes zoster infection or postherpetic neuralgia (PHN); not indicated for prophylaxis of primary varicella infection (chickenpox).
History of anaphylactic/anaphylactoid reaction to gelatin, neomycin (excluding contact dermatitis to neomycin), or any other component of the vaccine; immunosuppression or immunodeficiency, including individuals with leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary and acquired immunodeficiency states; AIDS or clinical manifestations of HIV; those receiving immunosuppressive therapy (including high-dose corticosteroids); pregnancy
In addition, ACIP recommends that the following immunocompromised patients should not receive zoster vaccine live (CDC/ACIP [Harpaz 2008]):
Patients undergoing hematopoietic stem cell transplant (limited data; assess risk:benefit, if needed, administer ≥24 months after transplantation).
Patients receiving recombinant human immune modulators, particularly antitumor necrosis factor agents (eg, adalimumab, infliximab, etanercept). Safety and efficacy of concurrent administration is unknown and not recommended. Defer vaccination for ≥1 month after discontinuation.
Patients with unspecified cellular immunodeficiency (exception, patients with impaired humoral immunity may receive vaccine).
Canadian labeling: Additional contraindications (not in US labeling): Active untreated tuberculosis
Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should NOT be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, outpatient visits solely for vaccination should be delayed in persons in quarantine due to close contact with COVID-19 or persons who have suspected or confirmed COVID-19 infection (regardless of symptoms); refer to the CDC's "Interim Guidance for Immunization Services During the COVID-19 Pandemic" for current recommendations (https://www.cdc.gov/vaccines/pandemic-guidance/index.html). Additional information is available from the American Academy of Pediatrics and the Immunization Action Coalition.
Note: Zostavax will no longer be available in the United States, effective July 1, 2020.
Manufacturer labeling: Adults ≥50 years of age: SubQ: 0.65 mL administered as a single dose.
ACIP recommendation: Adults ≥60 years of age: SubQ: 0.65 mL administered as a single dose; there are no data to support readministration of the vaccine (CDC/ACIP [Harpaz 2008]).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
Reconstitute with supplied diluent only, immediately upon removal from the freezer; use only sterile syringes free of preservatives, antiseptics, and detergents. Withdraw entire contents of the vial containing the provided diluent to reconstitute vaccine. Gently agitate to mix thoroughly. Withdraw entire contents of reconstituted vaccine vial for administration. Discard if reconstituted vaccine is not used within 30 minutes.
SubQ: Inject SubQ into the deltoid region of the upper arm. Do not administer IV or IM; inject immediately after reconstitution. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Ezeanolue 2020]). To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Ezeanolue 2020]). If purchased under Centers for Disease Control and Prevention contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
To maintain potency, the lyophilized vaccine must be stored frozen between -50°C to -15°C (-58°F to 5°F). Do not ship or store on dry ice as this may result in temperatures below -50°C (-58°F). Protect from light. Store diluent separately at room temperature of 20°C to 25°C (68°F to 77°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). The lyophilized vaccine may also be stored and/or transported under refrigeration at temperatures of 2°C to 8°C (36°F to 46°F) for 72 continuous hours prior to reconstitution; discard if not used within 72 hours.
Acyclovir-Valacyclovir: May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Avoid combination
AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification
Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Brexucabtagene Autoleucel: May enhance the adverse/toxic effect of Vaccines (Live). Brexucabtagene Autoleucel may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Brivudine [INT]: May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone >2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines prior to therapy whenever possible. Consider therapy modification
Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Deflazacort: May enhance the adverse/toxic effect of Vaccines (Live). Deflazacort may diminish the therapeutic effect of Vaccines (Live). Management: Administer all vaccines according to immunization guidelines prior to initiating deflazacort. Live vaccines should be administered at least 4 to 6 weeks prior to initiating deflazacort. Consider therapy modification
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Famciclovir: May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Avoid combination
Fingolimod: May enhance the adverse/toxic effect of Zoster Vaccine (Live/Attenuated). The risk of herpes zoster infection may be increased. Fingolimod may diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Management: Wait 1 month after zoster vaccine administration to initiate fingolimod therapy. Avoid the use of the zoster vaccine during fingolimod treatment, and for 2 months following treatment discontinuation. Consider therapy modification
Guselkumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination
Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification
Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification
Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Consider therapy modification
Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Pneumococcal Polysaccharide Vaccine (23-Valent): May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Monitor therapy
Risankizumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, do administer a scheduled PPD skin test for at least 4-6 weeks following administration of the vaccine. Simultaneous administration of a parenteral live vaccine and PPD skin test is acceptable. Consider therapy modification
Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Monitor therapy
Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Local: Pain at injection site (≤54%), erythema at injection site (36% to 48%), swelling at injection site (26% to 40%), localized tenderness (≤34%), injection site pruritus (7% to 11%)
1% to 10%:
Cardiovascular: Cardiac failure (≤2%)
Central nervous system: Headache (1% to 9%)
Gastrointestinal: Diarrhea (2%)
Local: Warm sensation at injection site (2% to 4%), hematoma at injection site (2%), induration at injection site (1%)
Neuromuscular & skeletal: Asthenia (1%), limb pain (1%)
Respiratory: Pulmonary edema (≤2%), respiratory tract disease (1%)
<1%, postmarketing, and/or case reports: Anaphylaxis, arthralgia, exacerbation of asthma, facial nerve paralysis, fever, Guillain-Barre syndrome, herpes zoster infection, hypersensitivity reaction, lymphadenopathy (transient), myalgia, nausea, necrotizing retinitis (patients on immunosuppressive therapy), polymyalgia rheumatica, rash at injection site, skin rash, urticaria at injection site, varicella zoster infection (in immunocompromised patients)
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Ezeanolue 2020]).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Ezeanolue 2020).
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Ezeanolue 2020]).
• Tuberculosis: Defer treatment in patients with active untreated tuberculosis.
• Zoster infection: Not for use in the treatment of active zoster outbreak; delay vaccination until after acute stage of illness and symptoms are no longer present (CDC/ACIP [Dooling 2018]). May be used in patients with previous history of zoster unless other contraindications to the vaccine exist (CDC/ACIP [Harpaz 2008]).
Concurrent drug therapy issues:
• Antiviral drugs: Medications active against the herpesvirus family (eg, acyclovir, famciclovir, valacyclovir) may interfere with the zoster vaccine live (ZVL); avoid ZVL vaccination to a patient who has received these antivirals 24 hours before vaccination; avoid use of these antiviral agents for 14 days after ZVL vaccination (CDC/ACIP [Harpaz 2008]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Ezeanolue 2020]).
• Adults: Not for use in patients <50 years of age.
• Altered immunocompetence: In patients where immunosuppressant therapy is anticipated, zoster vaccine live should be given at least 14 days to 1 month prior to beginning therapy when possible. Use is contraindicated in severely immunocompromised patients (eg, patients receiving chemo-/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination or may have an adverse event secondary to replication. Persons with AIDS or manifestations of HIV with CD4+ T-lymphocyte counts ≤200 cells/microliter or CD4+ T-lymphocyte percentages ≤15% should not be vaccinated. Patients receiving corticosteroids in low-to-moderate doses, topical (inhaled, nasal, skin), local injection (intra-articular, bursal, tendon) may receive vaccine. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines (ACIP [Ezeanolue 2020]); CDC/ACIP [Harpaz 2008]).
• Pediatric: Zoster vaccine live is not a substitute for varicella vaccine and should not be used in children and adolescents.
• Varicella vaccine recipients: The ACIP does not recommend zoster vaccine live for patients of any age who have received the varicella vaccine (CDC/ACIP [Harpaz 2008]). Patients can receive recombinant zoster vaccine (RZV) regardless of prior varicella vaccination (CDC/ACIP [Dooling 2018]).
Dosage form specific warnings:
• Gelatin: Contains gelatin; do not use in patients with a history of anaphylactic/anaphylactoid reaction to gelatin.
• Neomycin sensitivity: Contains neomycin; do not use in patients with a history of anaphylactic/anaphylactoid reaction to neomycin. Contact dermatitis to neomycin is not a contraindication to the vaccine.
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin 2014).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).
• Transmission of virus: Although transmission of the vaccine virus may occur between vaccinees and susceptible contacts, vaccinated individuals do not need to take precautions against spreading varicella following vaccination; transmission of virus is rare following vaccination unless rash develops. In case of rash, standard contact precautions should be followed. Persons with rash should avoid contact with persons at high risk for severe varicella infection until lesions have crusted (CDC/ACIP [Harpaz 2008])
Fever, rash; monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Per the manufacturer, women should avoid becoming pregnant for 3 months after vaccination (4 weeks per CDC) (CDC/ACIP [Harpaz 2008]).
Use during pregnancy is contraindicated.
Risk to the fetus following exposure to wild-type varicella zoster virus is small, and risk following exposure from the attenuated vaccine is probably even less (CDC/ACIP [Harpaz 2008]). Based on information collected from the manufacturer's pregnancy registry, of women who received a varicella-containing vaccine within 3 months of pregnancy or any time during pregnancy and who were available for analysis, there were no infants born with abnormalities consistent with congenital varicella syndrome. Information specific to exposure following zoster vaccine live was limited. Due to the rare incidence of congenital varicella syndrome and the low rates of varicella vaccine exposure in women of reproductive potential, the pregnancy registry has been closed. Although zoster vaccine live is not licensed for use in women within traditional reproductive ages, inadvertent exposures will still be monitored (Marin 2014).
Any exposures to the vaccine during pregnancy or within 3 months prior to pregnancy should continue to be reported to the manufacturer (Merck & Co, 877-888-4231) or to VAERS (800-822-7967) as suspected adverse reactions (Marin 2014).
What is this drug used for?
• It is used to prevent shingles.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Injection site pain or irritation
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about zoster vaccine live
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 11 Reviews
- Drug class: viral vaccines
- Zoster vaccine live
- Zoster vaccine, live Subcutaneous (Advanced Reading)
- Zoster Vaccine (Live/Attenuated)
Other brands: Zostavax