Shingles Vaccine: FAQs

(Updated March 2022)

The FAQ below addresses common clinical questions about the herpes zoster or shingles vaccines (Shingrix, Zostavax II [Canada]).

Question

Answer/Pertinent Information

What information should you know about the recombinant zoster vaccine (RZV; Shingrix)?

Vaccine type:13,14 RECOMBINANT, non-live, adjuvantedc (to boost immunity) vaccine.

Dosing:13,14 two IM doses 0.5 mL each. Second dose given two to six months AFTER the first dose.

  • If giving to a patient who is or will be immunocompromised and the patient would benefit from a shorter immunization schedule, the second dose can be given 4 weeks (one two month) AFTER the first dose.13,14,17
  • Series does NOT need to be restarted if more than six months have elapsed between the first and second dose.
  • The second dose should be repeated if given less than four weeks after the first dose.17
  • It is NOT necessary to re-administer Shingrix if accidentally given subcutaneously instead of IM.17

Adverse Reactions:

  • Incidence of injection site pain:13,14,b 69% to 88%
  • Systemic reactions occurring more commonly than with placebo:13,14 myalgia, fatigue, headache, fever/chills, GI
  • Adverse reactions with the first dose are not strongly predictive of adverse reactions to the second dose.17 However, headache and chills may be more common with the second dose compared to the first.13

Storage:13,14 36°F to 46°F (2°C to 8°C) (lyophilized antigen [vaccine] and adjuvant suspension [diluent])

Reconstitution and stability:13,14 Reconstitute with the diluent provided and use immediately or refrigerate between 36°F and 46°F (2°C and 8°C) and use within six hours.

What information should you know about the live-attenuated zoster vaccine (ZVL; Zostavax II [Canada])?

Vaccine type:3 LIVE-ATTENUATED vaccine

Dosing:3 single subcutaneous dose 0.65 mL

Adverse Reactions:

  • Incidence of injection site pain:3,a,b 54%
  • Systemic reaction occurring more commonly than with placebo:3,a headache

Storage:3 2°C to 8°C or colder (vaccine); 2°C to 8°C or 20°C to 25°C (diluent)

Reconstitution and Stability:3 reconstitute with the diluent provided and use within 30 minutes of reconstitution.

At what age should the shingles vaccine be given?

Risk of getting zoster or prolonged PHN pain rises with age, primarily after 60 years of age.5,8

Shingrix is the preferred shingles vaccine.2,27,28 Vaccination with Shingrix is recommended:

  • for people ≥50 years old.2,13,14,28  
  • for adults ≥19 years old (≥18 years [Canada]) considered at risk for shingles and who are or will be immunocompromised due to disease or therapy.14,34,35
  • even in patients who have previously been vaccinated with Zostavax (previously available in the U.S. until November 18, 2020) or Zostavax II (Canada).2,28
    • Give Shingrix (full series) as early as one year after Zostavax II (Canada) [Evidence Level C], but especially if it has been >5 years since Zostavax (not available in U.S. since November 18, 2020) or Zostavax II was given (most of the protection is lost by then).2,9,27,28

Zostavax II is Health Canada-approved and guideline recommended for people 50 years of age and older.2,3

  • It is NOT known if vaccination between the ages of 50 to 59 provides ongoing protection at older ages when zoster incidence and risk of complications is higher.2 (See duration of Zostavax II immunity below.)

Should patients who’ve had shingles receive the vaccine?

For immunocompetent patients with an indication for Shingrix, vaccination is recommended regardless of shingles or chickenpox history.2,28

  • More than 99% of adults ≥50 years old have been exposed to the varicella-zoster virus.28

Yes, immunocompromised patients ≥19 years old (≥18 years old [Canada]) who’ve previously been diagnosed with shingles by a healthcare provider should receive Shingrix.35

Different safety concerns are not expected in persons with a history of shingles.2,12

How long after a shingles episode can the vaccine be given?

Re-occurrence risk is low for up to 18 months after shingles due to residual immunity in immunocompetent patients.10

CDC: Wait until the acute stage shingles illness is over (i.e., symptoms subsided) to be vaccinated with Shingrix.28

NACI: Wait until one year has elapsed between the last shingles episode and zoster vaccination.2

  • Herpes ophthalmicus has recurred following shingles vaccination (Zostavax II).Causality has NOT been established, but inform patients that the risk/benefit is unknown.2

Can the shingles vaccine be administered with other vaccines or medications?

Shingrix can be given concomitantly (at separate sites) with live or inactivated vaccines, including the pneumococcal vaccine and Tdap [Evidence Level B-1].2,16,17,27

  • There are theoretical concerns about more side effects when giving two adjuvanted vaccines at the same time.15
    • Co-administration with adjuvanted flu vaccines (e.g., Fluad) has not been studied. However, don’t delay vaccination if only an adjuvanted flu vaccine is available.15 If an adjuvanted flu vaccine needs to be given with Shingrix, administer at separate sites.15

Zostavax II can be given concomitantly (at separate sites) with other live and inactivated vaccines.2

  • If Zostavax II is not given simultaneously (at separate injection sites) with another live injectable vaccine, separate the vaccines by ≥4 weeks.Four-week separation does NOT apply to live oral or intranasal vaccines.2
  • When possible, administer Zostavax II ≥24 hours after discontinuation of an antiviral agent active against herpes viruses (acyclovir, famciclovir, etc). Avoid restarting the antiviral for at least 14 days after vaccination.2
    • This is NOT a concern with Shingrix, as it is a recombinant vaccine (e.g., does not contain live virus).17

How long does immunity last?

Shingrix

  • Immune response appears to be maintained at least nine years after vaccination based on cellular response.20,21
    • It is unclear if this correlates to continued protection against shingles and PHN.20,21
  • Maintains >90% efficacy regardless of age at least four years after vaccination.19
    • Maintains about 88% efficacy four years after vaccination in patients vaccinated at 70 years of age or older.7

Zostavax II

  • Protection against zoster seems to last up to three years. Efficacy five years after vaccination is not known.2
  • Though studies are ongoing, there is no current recommendation for a booster or revaccination.2

How effective is the shingles vaccine?

Shingles

  • Shingrix: NNT ~37 patients to prevent one case of shingles over about three years in patients ≥50 years old.11
    • Clinical trials have NOT been conducted to evaluate the efficacy of Shingrix if just one dose is received.26
    • There is insufficient data available from post-hoc analyses to accurately predict the efficacy of Shingrix in patients that have only received one dose.26
  • Zostavax II NNT: ~59 patients to prevent one case of shingles over about three years in patients >60 years old.3,a

Postherpetic neuralgia (PHN)

  • All available vaccines have an NNT ~350 to prevent one case of PHN over about three years.7,25

What are considerations for immunocompromised patients and the shingles vaccine?

Shingrix (Canada: generally preferred over the live shingles vaccines in immunocompromised patients.22)

  • Data are growing about the safety and efficacy in immunocompromised patients, specifically in patients with HIV, hematologic cancers, post-transplant (renal and hematologic), and during chemotherapy.13,14,29-32
    • Shingrix is approved for use in adults ≥19 years old (≥18 years old [Canada]) who are considered at risk for shingles and are or will be immunocompromised due to disease or therapy.13,14,34
      • patients ≥50 years old (age group has a higher baseline risk of PHN37): recommend vaccination in patients with low- or high-level immunosuppression.13,14,34,38,e
      • patients 19 to 49 years old (Canada: 18 to 49 years old) (age group has a lower baseline risk of PHN37):
        • recommend vaccination in patients with high-level immunosuppression.38,e
        • consider use (weighing possible benefits and risks) in patients with low-level immunosuppression (e.g., taking prednisone chronically at doses <20 mg/day).38,e
    • Assess and document the need for Shingrix vaccination (varicella immunity) using one of the following: previously received two doses of a varicella vaccine, lab evidence of immunity or confirmation of disease, or diagnosis or verification of a history of chicken pox or shingles by a healthcare provider.35,f
    • If giving Shingrix as a part of a standing order, consider involving the medical director or the patient’s prescriber for the immunocompromising condition.36
    • Optimal timing of Shingrix vaccination may vary based on the patient’s immunocompromising condition. CDC provides guidance on timing at https://www.cdc.gov/shingles/vaccination/immunocompromised-adults.html.35 

Zostavax II (Canada)

  • Contraindicated (expert consultation is advised in complex cases) in patients with:2,3,22
    • primary immune deficiency (e.g., disorders of T-cell function)
    • acquired immune deficiency (e.g., blood dyscrasia, chemotherapy, radiation therapy, organ or stem cell transplant, cancer affecting the bone marrow or lymphatics, HIV if CD4 count is <200 106 cells/L).
    • leukocyte adhesion defect, Chediak-Higashi syndrome and other defects in cytotoxic granule release, and in undefined phagocytic cell defects.
  • When indicated (though Shingrix is preferred) can give to patients:22
    • with complement deficiency, neutropenia, or certain phagocytic defects (e.g., chronic granulomatous disease), or HIV with CD4 counts ≥200 x 106/L.22
    • taking antitumor necrosis factor biologics (TNF inhibitors), or on low-level immunosuppressive therapy (e.g., less than 14 days’ corticosteroid use, prednisone <20 mg daily or its equivalent, topical or inhaled corticosteroid, corticosteroid joint injection, methotrexate ≤0.4 mg/kg/week, azathioprine ≤3 mg/kg/day, or 6-mercaptopurine ≤1.5 mg/kg/day).18,22
    • at least four weeks before immunosuppressive therapy, four weeks after high-dose corticosteroids, or three months after other immunosuppressive drugs (e.g., cyclosporine, chemo).

What are considerations for pregnant and lactating patients and the shingles vaccine?

  • It is generally not necessary to avoid being around pregnant patients or young children after receiving either shingles vaccine, as there are not any documented cases of transmission from vaccinated adults.33
    • If a patient develops a rash after receiving a live zoster vaccine (Zostavax II), recommend covering the rash until the bumps crust over as a precaution against possible transmission.33

Shingrix

  • There are not enough data available to establish if there is risk with use in pregnant or breastfeeding patients.13,14

Zostavax II

  • Contraindicated during pregnancy.2,3
  • Patients should not become pregnant until at least three months after getting the vaccine.2,3

What are COVID-19 pandemic-related considerations with the shingles vaccine?

In the U.S.:23 Continue to give due or overdue shingles vaccine doses during the pandemic.

  • Vaccine series does NOT need to be restarted if more than six months have elapsed since the first dose before the second dose is given.17

In Canada:24 When possible, combine the shingles vaccination visit with another medical visit, to limit possible COVID-19 exposure risk. Consider deferring the second dose of Shingrix up to six months (12 months between the first and second dose). Base the timing of the second vaccination on local COVID-19 community transmission risk.

See our chart, FAQs: Immunizations During COVID-19, for answers to common questions, including guidance on counseling patients about systemic side effects that might mimic COVID-19 symptoms.

In the U.S., what are cost considerations with the shingles vaccine?

Shingrix costs about $340 total for the two-dose series and is covered by:1,4,d

  • Medicare Part D or Medicare Advantage Plan Part C
  • most private insurance plans (i.e., for patients between the ages of 50 and 65)

In Canada, what are cost considerations with the shingles vaccine?

In Ontario, patients 65 to 70 years of age can receive Shingrix free of charge from their primary care provider (transitioned from providing Zostavax II to Shingrix in October 2020).Patients who:6

  • received publicly funded Zostavax II are NOT eligible to receive publicly funded Shingrix.
  • paid out-of-pocket for Zostavax II ARE eligible to receive publicly funded Shingrix.
  • were born in 1949 or 1950 but missed the chance to receive the publicly funded shingles vaccine due to the COVID-19 pandemic are eligible to receive Shingrix through this program.
  • are from other provinces or who do NOT meet the age criteria can pay about $280 for the two-dose Shingrix series (preferred over Zostavax II2) or about $200 for Zostavax II.d
  1. Zostavax II product monograph references U.S. efficacy and adverse reaction trial data from Zostavax (no longer available in the U.S. as of November 18, 2020).3
  2. Shingrix causes more injection site pain; however, Zostavax II causes more redness and swelling (indirect comparisons).3,13,a
  3. Quillaja saponaria Molina, fraction 21 (QS-21), and 3-0-desacyl-4-monophosphoryl lipid A (MPL) act as adjuvants to boost immune response.13,14
  4. Pricing based on wholesale acquisition cost (WAC). U.S. medication pricing by Elsevier, accessed March 2021.
  5. In general, patients with higher levels of immunosuppression (e.g., hematopoietic stem cell transplant recipients) have a higher risk of developing shingles than patients with lower levels of immunosuppression (e.g., people living with HIV, autoimmune or inflammatory conditions).37
  6. When there is no available documentation of varicella immunity, consider other factors to weigh risks and benefits for Shingrix vaccination (e.g., does patient recall having the chicken pox, is it highly likely that the patient previously had the chicken pox [e.g., born before 1980]).35 Patients without varicella immunity would be at risk of chicken pox, not shingles.

Abbreviations: CDC = Centers for Disease Control and Prevention; FDA = U.S. Food and Drug Administration; GI = gastrointestinal (e.g., nausea, vomiting, diarrhea, abdominal pain); HIV = human immunodeficiency syndrome; NACI = National Advisory Committee on Immunization; NNT = number needed to treat; PHN = postherpetic neuralgia.

Levels of Evidence

In accordance with our goal of providing Evidence-Based information, we are citing the LEVEL OF EVIDENCE for the clinical recommendations we publish.

Level

Definition

Study Quality

A

Good-quality patient-oriented evidence.*

  1. High-quality RCT
  2. SR/Meta-analysis of RCTs with consistent findings
  3. All-or-none study

B

Inconsistent or limited-quality patient-oriented evidence.*

  1. Lower-quality RCT
  2. SR/Meta-analysis with low-quality clinical trials or of studies with inconsistent findings
  3. Cohort study
  4. Case control study

C

Consensus; usual practice; expert opinion; disease-oriented evidence (e.g., physiologic or surrogate endpoints); case series for studies of diagnosis, treatment, prevention, or screening.

*Outcomes that matter to patients (e.g., morbidity, mortality, symptom improvement, quality of life).

RCT = randomized controlled trial; SR = systematic review [Adapted from Ebell MH, Siwek J, Weiss BD, et al. Strength of Recommendation Taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician 2004;69:548-56. http://www.aafp.org/afp/2004/0201/p548.pdf.]

References

  1. CDC. Protect your patients with the new shingles vaccine. https://www.cdc.gov/shingles/downloads/shingles-factsheet-hcp.pdf. (Accessed March 3, 2021).
  2. Herpes zoster (shingles) vaccine: Canadian immunization guide: part 4-active vaccines. Complete revision August 2018. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-8-herpes-zoster-(shingles)-vaccine.html. (Accessed March 4, 2021).
  3. Product monograph for Zostavax II. Merck Canada. Kirkland, QC H9H 4M7. November 2018.
  4. CDC. Vaccine information for adults: how to pay for vaccines. March 31, 2017. https://www.cdc.gov/vaccines/adults/pay-for-vaccines.html. (Accessed March 4, 2021).
  5. CDC. Shingles (herpes zoster): shingles burden and trends. August 14, 2019. https://www.cdc.gov/shingles/surveillance.html. (Accessed March 4, 2021).
  6. Ministry of Health. Ontario publicly funded shingles (herpes zoster) immunization program: Shingrix vaccine information for patients. http://www.health.gov.on.ca/en/public/programs/immunization/docs/shingles_patient_fact_sheet_en.pdf. (Accessed March 4, 2021).
  7. Cunningham AL, Lal H, Kovac M, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med 2016;375:1019-32.
  8. Mayo Clinic. Postherpetic neuralgia. https://www.mayoclinic.org/diseases-conditions/postherpetic-neuralgia/symptoms-causes/syc-20376588#. (Accessed March 4, 2021).
  9. CDC. Vaccines and preventable diseases: what everyone should know about Zostavax. October 5, 2020. https://www.cdc.gov/vaccines/vpd/shingles/public/zostavax/index.html. (Accessed March 4, 2021).
  10. Tseng HF, Chi M, Smith N, et al. Herpes zoster vaccine and the incidence of recurrent herpes zoster in an immunocompetent elderly population. J Infect Dis 2012;206:190-6.
  11. Lal H, Cunningham AL, Godeaux O, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 2015;372:2087-96.
  12. Mills R, Tyring SK, Levin MJ, et al. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine 2010;28:4204-9.
  13. Product information for Shingrix. GlaxoSmithKline Biologicals. Research Triangle Park, NC 27709. July 2021.
  14. Product monograph for Shingrix. GlaxoSmithKline. Mississauga, Ontario L5N 6L4. November 2021.
  15. CDC. Prevention and control of seasonal influenza with vaccines: recommendations of the advisory committee on immunization practices-United States, 2020-21 influenza season. August 21, 2020. https://www.cdc.gov/mmwr/volumes/69/rr/rr6908a1.htm. (Accessed March 4, 2021).
  16. Strezova A, Lal H, Enweonye I, et al. The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults ≥50 years: a randomized trial. Vaccine 2019;37:5877-85.
  17. Immunize Action Coalition. Ask the experts: zoster (shingles). Updated March 9, 2022. https://www.immunize.org/askexperts/experts_zos.asp. (Accessed March 15, 2021).
  18. American College of Rheumatology. Press release: live zoster vaccine safe and effective for people taking TNF inhibitors. November 9, 2019. https://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/1056. (Accessed March 4, 2021).
  19. CDC. Advisory Committee on Immunization Practices (ACIP): summary report. October 25-26, 2017. https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2017-10-508.pdf. (Accessed April 14, 2021).
  20. CDC. ACIP summary report February 2017. https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2017-02.pdf. (Accessed April 14, 2021).
  21. Pauksens K, Volpe S, Schwarz TF, et al. Persistence of immune response to an adjuvanted varicella-zoster virus subunit candidate vaccine for up to year 9 in older adults. Poster presentation 1343. October 6, 2017. ID Week 2017. https://idsa.confex.com/idsa/2017/webprogram/Paper66091.html. (Accessed March 4, 2021).
  22. Immunization of immunocompromised persons. Page 8: Canadian immunization guide: part 3 – vaccination of specific populations. Updated May 2018. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-3-vaccination-specific-populations/page-8-immunization-immunocompromised-persons.html#doa. (Accessed April 14, 2021).
  23. CDC. Pandemic guidance: interim guidance for routine and influenza immunization services during the COVID-19 pandemic. October 20, 2020. https://www.cdc.gov/vaccines/pandemic-guidance/index.html. (Accessed March 4, 2021).
  24. Health Canada. Interim guidance on continuity of immunization programs during the COVID-19 pandemic. May 13, 2020. https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/interim-guidance-immunization-programs-during-covid-19-pandemic.html. (Accessed March 4, 2021).
  25. 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;352:2271-84.
  26. Public Health Madison & Dane County. Vaccine efficacy after one dose of Shingrix in adults ≥50 years of age. https://publichealthmdc.com/documents/Efficacy%20After%20One%20Dose%20i.pdf. (Accessed March 4, 2021).
  27. CDC. Morbidity and mortality weekly report (MMWR). Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. January 26, 2018. https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm. (Accessed March 3, 2021).
  28. CDC. Vaccines and preventable diseases. Shingrix recommendations. October 5, 2020. https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/recommendations.html. (Accessed March 4, 2021).
  29. Berkowitz EM, Moyle G, Stellbrink HJ. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo controlled study. J Infect Dis 2015;211:1279-87.
  30. Poster presentation (1349). Infectious Diseases Society of America Conference. October 2017. Immunogenicity and safety of a candidate subunit adjuvanted herpes zoster vaccine in adults with solid tumors vaccinated before or during immunosuppressive chemotherapy treatment: a phase II/III, randomized clinical trial. https://idsa.confex.com/idsa/2017/webprogram/Paper62593.html. (Accessed March 4, 2021).
  31. Poster presentation (1348). Infectious Diseases Society of America Conference. October 2017. Immunogenicity and safety of a candidate subunit adjuvanted herpes zoster vaccine (HZ/su) in adults post renal transplant: a phase III randomized clinical trial. https://idsa.confex.com/idsa/2017/webprogram/Paper65338.html. (Accessed March 4, 2021).
  32. Poster presentation (1344). Infectious Diseases Society of America Conference. October 2017. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults with hematologic malignancies: a phase III, randomized clinical trial. https://idsa.confex.com/idsa/2017/webprogram/Paper66049.html. (Accessed March 4, 2021).
  33. Mayo Clinic. Shingles vaccine: can I transmit the vaccine virus to others? July 14, 2020. https://www.mayoclinic.org/diseases-conditions/shingles/expert-answers/shingles-vaccine/faq-20058137. (Accessed March 8, 2021).
  34. CDC. Advisory Committee on Immunization Practices (ACIP).  ACIP recommendations:  October 2021.  https://www.cdc.gov/vaccines/acip/recommendations.html.  (Accessed November 16, 2021).
  35. CDC. Clinical considerations for use of recombinant zoster vaccine (RZV, Shingrix) in immunocompromised adults aged ≥19 years. January 20, 2022. https://www.cdc.gov/shingles/vaccination/immunocompromised-adults.html. (Accessed March 15, 2022).
  36. Immunize Action Coalition. Standing orders for administering recombinant zoster vaccine to adults. March 2022. https://www.immunize.org/catg.d/p3092.pdf. (Accessed March 16, 2022).
  37. CDC. Economics of vaccinating immunocompromised 19-49-years-old adults against herpes zoster in the US. September 29, 2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-09-29/02-ZosterVaccines-OrtegaSanchez-508.pdf. (Accessed March 18, 2022).
  38. Personal communication (written). Sarah: Immunization Services Division. CDC. March 16, 2022.

Cite this document as follows: Clinical Resource, Shingles Vaccine: FAQs. Pharmacist’s Letter/Prescriber’s Letter. April 2021. [370435]

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