Zoster (shingles) vaccine, live attenuated: Drug information
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(For additional information see "Zoster (shingles) vaccine, live attenuated: Patient drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US
  • Zostavax
Brand Names: Canada
  • Zostavax
Pharmacologic Category
  • Vaccine;
  • Vaccine, Live (Viral)
Dosing: Adult

Shingles prevention:

Manufacturer labeling: Adults ≥50 years: SubQ: 0.65 mL administered as a single dose

ACIP recommendation: Adults ≥60 years: 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 chronic use of acyclovir, famciclovir, or valacyclovir: Discontinue acyclovir, famciclovir, or valacyclovir ≥24 hours before administration of zoster vaccine. Do not use acyclovir, famciclovir, or valacyclovir for ≥14 days after vaccination (CDC/ACIP [Harpaz 2008]).

Dosing: Renal Impairment (Adult)

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment (Adult)

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Geriatric

Refer to adult dosing.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Subcutaneous [preservative free]:

Zostavax: 19,400 units/0.65 mL (1 ea) [contains gelatin (pork)]

Generic Equivalent Available (US)

No

Dosage Forms Considerations

Zostavax contains porcine gelatin

Medication Guide and/or Vaccine Information Statement (VIS)

In the US, the CDC-approved Vaccine Information Statement (VIS) is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/shingles.html.

Administration

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 [Kroger 2017]). To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2017]). US federal law requires that the name of medication, date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

Use

Herpes zoster prevention: Prevention of herpes zoster (shingles) in patients ≥50 years of age

The Advisory Committee on Immunization Practices (ACIP) recommends:

Routine vaccination of all patients ≥60 years of age, including patients who report a previous episode of zoster; patients with chronic medical conditions (eg, chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease) unless those conditions are contraindications; and residents of nursing homes and other long-term care facilities ≥60 years of age without contraindications (CDC/ACIP [Harpaz, 2008]).

Limitations of use: Not indicated for treatment of zoster or postherpetic neuralgia (PHN); not indicated for prophylaxis of primary varicella infection (chickenpox).

Medication Safety Issues
Sound-alike/look-alike issues:

Zoster Vaccine (Live) may be confused with Zoster Vaccine (Recombinant)

Zostavax (zoster vaccine [live]) may be confused with Shingrix (zoster vaccine [recombinant])

ZVL (zoster vaccine [live]) may be confused with RZV (zoster vaccine [recombinant])

RZV (zoster vaccine [recombinant]), ZVL (zoster vaccine [live]), or HZV (herpes zoster vaccine) may be confused with VAR (varicella vaccine)

Administration issues:

Both varicella vaccine and zoster vaccine are live, attenuated strains of varicella-zoster virus. Their indications, dosing, and composition are distinct. Varicella vaccine is indicated for the prevention of chickenpox, while zoster vaccine is indicated in older individuals to prevent reactivation of the virus which causes shingles. Zoster vaccine is not a substitute for varicella vaccine and should not be used in children.

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index.

>10%: Local: Pain at injection site (≤34 to 54%), erythema at injection site (36% to 48%), swelling at injection site (26% to 40%), localized tenderness (≤34%), itching at injection site (7% to 11%)

1% to 10%:

Cardiovascular: Congestive 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: Weakness (1%), limb pain (1%)

Respiratory: Pulmonary edema (≤2%), respiratory tract disease (1%)

<1%, postmarketing, and/or case reports: Anaphylaxis, arthralgia, exacerbation of asthma, fever, herpes zoster, hypersensitivity reaction, lymphadenopathy (transient), myalgia, nausea, necrotizing retinitis (patients on immunosuppressive therapy), polymyalgia rheumatica, rash at injection site, skin rash (noninjection site), urticaria at injection site

Contraindications

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 (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).

Warnings/Precautions

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 [Kroger 2017]).

• 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 [Kroger 2017]).

Disease-related concerns:

• 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 [Kroger 2017]).

• Tuberculosis: Defer treatment in patients with active untreated tuberculosis.

• Zoster infection: Not for use in the treatment of active zoster outbreak. 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; avoid zoster vaccination to a patient who has received these antivirals 24 hours before vaccination; avoid use of these antiviral agents for 14 days after zoster vaccination (ACIP [Kim 2016]; 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 [Kroger 2017]).

Special populations:

• Adults: Not for use in patients <50 years of age.

• Altered immunocompetence: In patients where immunosuppressant therapy is anticipated, zoster vaccine 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 [Kroger 2017]); CDC/ACIP [Harpaz 2008]).

• Pediatric: Zoster vaccine 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 vaccination in patients of any age who have received the varicella vaccine (CDC/ACIP [Harpaz 2008]).

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.

Other warnings/precautions:

• 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 ACIP Recommended Immunization Schedules (ACIP [Kim 2017]; CDC/ACIP [Robinson 2017]). 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 [Kroger 2017]).

• 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])

Metabolism/Transport Effects

None known.

Drug Interactions

(For additional information: Launch drug interactions program)

Acyclovir-Valacyclovir: May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Management: When possible, discontinue antiviral agents with anti-zoster activity (i.e., acyclovir, valacyclovir, famciclovir) for at least 24 hours prior to and 14 days after receiving a live attenuated zoster vaccine. Risk X: Avoid combination

Axicabtagene Ciloleucel: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of infection may be increased. Axicabtagene Ciloleucel may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live virus vaccines for at least 6 weeks prior to initiation of lymphodepleting therapy, during axicabtagene ciloleucel infusion, and after treatment until full immune recovery is achieved. Risk D: Consider therapy modification

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. Risk D: Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Risk D: Consider therapy modification

Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

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: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this. Risk D: Consider therapy modification

Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination

Famciclovir: May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Management: When possible, discontinue antiviral agents with anti-zoster activity (i.e., acyclovir, valacyclovir, famciclovir) for at least 24 hours prior to and 14 days after receiving a live attenuated zoster vaccine. Risk X: 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. Risk D: Consider therapy modification

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. Exceptions: AzaTHIOprine; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; Dexamethasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Risk X: 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. Risk D: 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. Risk D: 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. Risk D: Consider therapy modification

Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Pneumococcal Polysaccharide Vaccine (23-Valent): May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Risk C: Monitor therapy

Rabies Immune Globulin (Human): May diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. Risk D: Consider therapy modification

Tisagenlecleucel: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of infection may be increased. Tisagenlecleucel may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live virus vaccines for two weeks prior to initiation of lymphodepleting therapy, during tisagenlecleucel infusion, and after treatment until full immune recovery is achieved. Risk D: Consider therapy modification

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. Risk D: 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. Exceptions: Adenovirus (Types 4, 7) Vaccine; Cholera Vaccine; Rotavirus Vaccine. Risk C: 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. Risk X: Avoid combination

Pregnancy Implications

Use during pregnancy is contraindicated.

Women should avoid becoming pregnant for 3 months after vaccination (4 weeks per CDC). 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 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 is not licensed for use in women within traditional reproductive ages, inadvertent exposures will still be monitored.

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).

Breast-Feeding Considerations

It is not known if virus from this vaccine is present in breast milk. Administration does not affect the safety of breastfeeding for the mother or the infant (ACIP [Kroger 2017]). According to the manufacturer, the decision to breastfeed following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Fever, rash; monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Mechanism of Action

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, with the highest efficacy in patients 60-69 years of age. It may also reduce the severity of complications, including postherpetic neuralgia, in patients who develop zoster following vaccination.

Zoster vaccine reduced the incidence of zoster by ~70% in those 50 to 59 years of age, 64% in those 60-69 years of age, 41% in those 70-79 years of age, and 18% in those 80 years and older. The overall efficacy for those 60 years and older was 51%. 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.

Pharmacodynamics/Kinetics

Onset of action: Seroconversion: ~6 weeks (CDC/ACIP [Harpaz, 2008])

Duration: Not established; protection has been demonstrated for at least 4 years

Pricing: US

Suspension (reconstituted) (Zostavax Subcutaneous)

19400 units/0.65 mL (1): $267.74

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Zostavax (AT, AU, BB, CH, CR, CZ, DE, DK, DO, EE, ES, FR, GT, HK, HN, HR, HU, ID, IE, IL, KR, LT, LU, MT, MY, NI, NL, NO, NZ, PA, PL, PT, RO, SE, SG, SI, SK, SV, TH)
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REFERENCES

  1. Dooling KL, Guo A, Patel M, Lee GM, et al. Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMWR Morb Mortal Wkly Rep. 2018;67(3):103-108. doi: 10.15585/mmwr.mm6703a5. [PubMed 29370152]10.15585/mmwr.mm6703a5
  2. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP); Centers for Disease Control and prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30. http://www.cdc.gov/mmwr/PDF/rr/rr5705.pdf. [PubMed 18528318]
  3. Kim DK, Riley LE, Harriman KH, et al; Advisory Committee on Immunization Practices (ACIP), ACIP Adult Immunization Work Group. Advisory Committee on Immunization Practices recommended immunization schedule for adults aged 19 years or older—United States, 2017. MMWR Morb Mortal Wkly Rep. 2017; 66(5):136-138. doi: 10.15585/mmwr.mm6605e2. [PubMed 28182599]
  4. Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed April 4, 2017.
  5. Marin M, Willis ED, Marko A, Rasmussen SA, Bialek SR, Dana A; Centers for Disease Control and Prevention (CDC). Closure of varicella-zoster virus-containing vaccines pregnancy registry - United States, 2013. MMWR Morb Mortal Wkly Rep. 2014;63(33):732-733. [PubMed 25144545]
  6. Oxman MN, Levin MJ, Johnson GR, et al, “A Vaccine to Prevent Herpes Zoster and Postherpetic Neuralgia in Older Adults,” N Engl J Med, 2005, 352(22):2271-84. [PubMed 15930418]
  7. Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):e44-e100. [PubMed 24311479]
  8. Zostavax (zoster vaccine live) [prescribing information]. Whitehouse Station, NJ: Merck & Co; September 2017.
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