Zoster (shingles): recombinant zoster vaccine (Shingrix)

The disease and why it matters

Herpes zoster (shingles) is caused by reactivation of varicella-zoster virus (VZV), the same virus that causes varicella (chickenpox); the virus stays dormant after chickenpox and can reactivate later in life. ^[1]

About 1 in 3 people in the United States will develop shingles in their lifetime. ^[2] CDC estimates about one million cases of herpes zoster occur each year in the United States, ^[1] and the Pink Book puts the lifetime risk at at least 32%. ^[3]

Risk of zoster and of related complications, including hospitalization, rises sharply after age 50, and rises as VZV-specific cell-mediated immunity declines with age or with disease or drugs that suppress the immune system. ^[1]

The most common complication is postherpetic neuralgia (PHN): about 10% to 18% of people with zoster develop it, and the risk rises with age. ^[2] Other complications include hearing or vision loss, encephalitis, and pneumonia. ^[1]

Approximately 1 to 4% of people with shingles are hospitalized for complications, and about 30% of people in the hospital for shingles have a weakened or suppressed immune system. ^[2] Fewer than 100 people die from shingles each year, almost all of them older adults or people with compromised immune systems. ^[2]

A person with zoster is contagious from rash onset until the lesions crust; zoster is about one-fifth as infectious as varicella, and exposure causes varicella, not zoster, in a person who has never had it. ^[3]

Antiviral treatment is most effective within 72 hours of symptom onset; CDC lists acyclovir, valacyclovir and famciclovir as the three preferred antivirals for initial treatment. ^[1]

Video and figures

Video

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Shingles - VEC Vaccine Notes | Vaccine Education Center at Children’s Hospital of Philadelphia
Channel: Vaccine Education Center at CHOP · Uploaded February 25, 2026 · Confirmed available October 12, 2026 · Open on YouTubeRxEvidence has not checked every statement in this video.

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Shingrix is the only zoster vaccine licensed and available for use in the United States according to the Pink Book; the live vaccine, Zostavax, has not been available since November 18, 2020. ^{[3] [4]}

Who should get it

FDA-approved indications are prevention of herpes zoster in adults aged 50 years and older, and in adults aged 18 years and older who are or will be at increased risk because of immunodeficiency or immunosuppression caused by known disease or therapy. Shingrix is not indicated for prevention of primary varicella infection (chickenpox). ^[6]

The FDA label begins the immunocompromised indication at age 18, while ACIP's recommendation begins at 19; ACIP voted for 19 and older to align with the age range in the adult immunization schedule. ^[8]

Older text to be aware of: the Pink Book chapter (14th edition, published August 2021) says immunocompromised people on moderate- to high-dose immunosuppressive therapy were excluded from the efficacy studies and that ACIP "has not yet made recommendations" for them, while also warning that its vaccine-specific recommendations may be outdated. ACIP subsequently recommended RZV for immunocompromised adults aged 19 years and older on October 20, 2021. ^{[3] [8]}

Evidence for the benefit comes from two randomized, placebo-controlled, observer-blind trials that the label calls Study 1 (adults 50 years and older) and Study 2 (adults 70 years and older); CDC refers to them as ZOE-50 and ZOE-70. ^{[6] [12]}

In descriptive analyses, efficacy in the fourth year after vaccination was 93.1% (95% CI 81.3, 98.2) in adults 50 years and older (Study 1) and 85.1% (95% CI 64.5, 94.8) in adults 70 years and older (Study 2). ^[6]

In an open-label long-term follow-up of Study 1 and 2 participants, from a median of 5.6 to 11.4 years after vaccination, zoster incidence was 1.0, 1.3, 2.3 and 2.5 per 1,000 person-years for people vaccinated at ages 50–59, 60–69, 70–79 and 80 years or older. The label notes these rates were higher than in the vaccinated groups during Studies 1 and 2 and lower than in the placebo groups. ^[6]

Against PHN, no cases occurred in the vaccine group versus 18 in the placebo group among Study 1 participants aged 50 and older, and pooled efficacy against PHN in adults 70 and older was 88.8% (95% CI 68.7, 97.1). ^[6]

Dosing and schedule, including catch-up

The label directs two doses (0.5 mL each) given intramuscularly; the second dose is given 2 to 6 months after the first, and for people who are or will be immunodeficient or immunosuppressed and would benefit from a shorter schedule, 1 to 2 months after the first. ^[6] CDC states the same intervals. ^[4]

The minimum interval is 4 weeks, and a second dose given sooner than 4 weeks after the first should be repeated at least 4 weeks after the dose given too early. ^{[13] [8]} Immunize.org applies the general grace period: a second dose given more than 4 days sooner than 4 weeks is repeated. ^[11]

Catch-up: if more than 6 months have passed since dose 1, give dose 2 as soon as possible and do not restart the series. ^{[4] [11]}

Two doses are recommended whether or not the person reports a prior episode of herpes zoster or a prior dose of Zostavax. ^[4] CDC advises waiting at least 8 weeks after Zostavax; the Pink Book gives not less than 2 months as expert opinion. ^{[4] [3]}

CDC notes that intervals shorter than 5 years between Zostavax and Shingrix were not studied, but that there are no theoretical or data concerns that Shingrix would be less safe or effective at shorter intervals. ^[4] The label's revaccination study enrolled adults aged 65 years and older vaccinated with Zostavax more than 5 years earlier. ^[6]

For a patient who previously had herpes zoster there is no specific waiting period, but Shingrix should not be given during an acute episode. ^[4]

CDC states there is no recommendation for booster doses of RZV at this time. ^[14]

If a dose is given in error to an immunocompetent adult aged 18 through 49 years, CDC does not recommend repeating it, and the second dose should not be given until the 50th birthday (Immunize.org summary of CDC guidance). If varicella vaccine was given in error, a Shingrix series should start at least 8 weeks later. ^[11]

Administration

Give a single 0.5 mL dose by intramuscular injection; the preferred site is the deltoid region of the upper arm. ^[6]

Vial and vial presentation: reconstitute the lyophilized gE antigen with only the supplied adjuvant suspension component, gently swirl until the powder is dissolved without shaking vigorously, and give immediately or store refrigerated at 2° to 8°C (36° to 46°F) and use within 6 hours. ^[6]

Prefilled syringe presentation: no reconstitution; attach a sterile needle and administer intramuscularly. The syringes are Luer Lock and are packaged without needles. ^[6]

The vaccine is an opalescent, colorless to pale brownish liquid; inspect for particulate matter and discoloration and do not administer if either is present. ^[6]

CDC states that recombinant and adjuvanted vaccines such as Shingrix can be given at different anatomic sites with other adult vaccines, including COVID-19 vaccines; the same page notes that coadministration with adjuvanted influenza vaccine (Fluad) and COVID-19 vaccines is being studied. ^[4]

Label trials of same-day administration in adults 50 years and older with quadrivalent influenza vaccine, PPSV23, PCV13 and Tdap (Boostrix) showed no evidence of interference with the immune responses, with one exception: the anti-pertactin response to Boostrix did not meet the non-inferiority criterion when given together. With PPSV23 given with dose 1, more subjects reported fever (16% vs. 7%) and shivering (21% vs. 7%) than with Shingrix dose 1 alone. ^[6]

Syncope can occur with injectable vaccines; procedures should be in place to avoid falling injury and to restore cerebral perfusion. ^[6]

Storage and handling

Vials (lyophilized gE antigen and adjuvant suspension): store refrigerated at 2°C to 8°C (36°F to 46°F), protect from light, do not freeze, and discard if frozen. ^[6] The Pink Book gives the same storage conditions before reconstitution. ^[3]

After reconstitution: administer immediately or store refrigerated at 2°C to 8°C for up to 6 hours, discard if not used within 6 hours, and discard if frozen. ^[6]

Prefilled syringe: store refrigerated at 2°C to 8°C, protect from light, do not freeze (discard if frozen); administer as soon as possible after removal from the refrigerator; it may be kept for up to 72 hours at 8°C to 25°C (46°F to 77°F). ^[6]

CDC's storage toolkit states that vaccines stored outside recommended temperatures should not be used unless safety and effectiveness are confirmed by public health authorities or the manufacturer. ^[15]

Contraindications and precautions

• Contraindication: a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of Shingrix. ^{[6] [8]}
• Precaution: moderate or severe acute illness with or without fever; vaccination should generally be delayed, whereas minor illness such as a cold does not preclude vaccination. ^{[8] [16]}
• Precaution: a current episode of herpes zoster; delay vaccination until the acute stage is over and symptoms abate. Shingrix is not a treatment for herpes zoster or PHN. ^[8]
• The label carries a warning for Guillain-Barré syndrome observed in the 42 days after vaccination (see Safety). ^[6]
• Shingrix is not indicated to prevent varicella and has not been evaluated in people who are seronegative to varicella. ^[4]
• Because Shingrix is not a live vaccine, it may be given while patients are taking antiviral medications. ^[8]

CDC's adult-schedule appendix lists, for RZV, a severe allergic reaction to a previous dose or a vaccine component, moderate or severe acute illness with or without fever, and a current episode of herpes zoster. ^[17]

Safety and adverse events

In two pooled placebo-controlled studies of adults 50 years and older, the proportions reporting solicited reactions within 7 days (both doses combined) were pain 78%, redness 38% and swelling 26%, and myalgia 45%, fatigue 45%, headache 38%, shivering 27%, fever 21% and gastrointestinal symptoms 17%. The reactions had a median duration of 2 to 3 days. ^[6]

Grade 3 reactions (severe enough to prevent normal activities) were reported by 9.4% of vaccine recipients for injection-site reactions and 10.8% for systemic events, compared with 0.3% and 2.4% of placebo recipients; grade 3 local reactions were equally frequent after doses 1 and 2, while grade 3 systemic reactions were reported more often after dose 2. ^[3]

Serious adverse events were reported at similar rates in vaccine and placebo recipients (2.3% and 2.2%) from the first dose up to 30 days after the last dose. ^[6]

In the label's secondary analyses the increased GBS risk was seen after the first dose (an estimated 6 excess cases per million doses, 95% CI 3.4, 9.6, in one study and 12 per million doses, 95% CI 8.9, 13.4, in the other) and no increased risk was observed after the second dose. ^[6]

Postmarketing reports include decreased mobility of the injected arm that may persist for 1 or more weeks, injection site induration, and hypersensitivity reactions including angioedema, rash and urticaria. ^[6]

Suspected adverse reactions can be reported to VAERS at 1-800-822-7967 or to GlaxoSmithKline at 1-888-825-5249. ^[6]

Special populations

Immunocompromised adults: in the label's trials, efficacy against herpes zoster was 68.2% (95% CI 55.5, 77.6) in autologous hematopoietic stem cell transplant recipients and, in a post hoc analysis, 87.2% (95% CI 44.2, 98.6) in people with hematologic malignancies. ^[6] Solicited pain in the transplant study was reported by 88% of recipients aged 18 through 49 and 83% of those 50 and older. ^[6]

• Timing for immunocompromised patients: when possible vaccinate before immunosuppression begins; if not possible, time vaccination for when the immune response is likely to be most robust. ^[14]
• Hematopoietic cell transplant: autologous, at least 3 to 12 months after transplantation, and allogeneic, at least 6 to 12 months after, depending on when prophylactic antiviral therapy is discontinued. ^[14]
• Solid organ transplant: when possible before transplantation; otherwise at least 6 to 12 months after, preferably with stable graft function on maintenance immunosuppression. ^[14]
• Anti-B cell therapy (e.g., rituximab): give a dose approximately 4 weeks before the next scheduled therapy. ^[14]
• HIV: administration of recombinant vaccines does not have to be delayed until viral suppression or higher CD4 counts are reached, and patients with advanced HIV should receive RZV because their zoster risk is further increased. ^[14]

Older adults: the label reports no clinically meaningful differences in efficacy across age groups, and solicited reactions were less frequent at ages 70 years and older than at 50 through 69 years. ^[6]

Children and adolescents: safety and effectiveness in individuals younger than 18 years have not been established. ^[6]

Varicella history: for immunocompetent adults 50 years and older there is no need to screen for varicella history or test serology before Shingrix; more than 99% of Americans born before 1980 have had varicella. For immunocompromised patients, evidence of immunity to varicella is documentation of 2 doses of varicella vaccine, laboratory evidence of immunity or confirmation of disease, or a healthcare provider diagnosis or verification of varicella or herpes zoster history; birth before 1980 does not count for them. ^{[4] [14]}

Counseling pearls for the pharmacy counter

• Before vaccination, counsel about expected local and systemic reactions, including grade 3 reactions, which are severe enough to prevent normal activities. ^[8]
• Reactions usually go away on their own in 2 to 3 days. ^[16]
• Encourage completing both doses even after a (non-anaphylactic) grade 1 to 3 reaction to dose 1. ^[8]
• Prophylactic antipyretic or analgesic medication before vaccination is generally not recommended; they may be taken to treat symptoms afterward. ^[8]
• Stress the importance of completing the 2-dose series on schedule and give the Vaccine Information Statement. ^[6]
• Tell patients that signs of a severe allergic reaction (hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness) need 9-1-1. ^[16]
• Shingrix prevents shingles; it is not a treatment for an episode of shingles or for PHN. ^[8]

Common patient questions

References

1. Centers for Disease Control and Prevention. Clinical overview of shingles (herpes zoster). Page dated June 27, 2024. Accessed October 11, 2026. https://www.cdc.gov/shingles/hcp/clinical-overview/index.html. Accessed October 11, 2026.
2. Centers for Disease Control and Prevention. Shingles facts and stats. Page dated April 12, 2024. Accessed October 11, 2026. https://www.cdc.gov/shingles/data-research/index.html. Accessed October 11, 2026.
3. Centers for Disease Control and Prevention. Zoster. In: Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book), 14th ed. (published August 2021), web chapter. Accessed October 11, 2026. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-23-zoster.html. Accessed October 11, 2026.
4. Centers for Disease Control and Prevention. Shingles vaccine recommendations: information for healthcare professionals. Page dated October 22, 2024. Accessed October 11, 2026. https://www.cdc.gov/shingles/hcp/vaccine-considerations/index.html. Accessed October 11, 2026.
5. U.S. Food and Drug Administration. SHINGRIX (STN 125614). Content current as of 02/17/2026. Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/shingrix. Accessed October 11, 2026.
6. SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), injectable suspension, for intramuscular use: prescribing information. GlaxoSmithKline Biologicals; revised 2/2026. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/108597/download?attachment. Accessed October 11, 2026.
7. U.S. Food and Drug Administration. BLA approval letter, Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX), STN BL 125614/0. October 20, 2017. Accessed October 11, 2026. https://www.fda.gov/media/108274/download?attachment. Accessed October 11, 2026.
8. Anderson TC, Masters NB, Guo A, et al. Use of recombinant zoster vaccine in immunocompromised adults aged 19 years and older: recommendations of the Advisory Committee on Immunization Practices, United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(3):80-84. Accessed October 11, 2026. https://www.cdc.gov/mmwr/volumes/71/wr/mm7103a2.htm. Accessed October 11, 2026.
9. U.S. Food and Drug Administration. Supplement approval letter, SHINGRIX, STN BL 125614/1206. February 13, 2026. Accessed October 11, 2026. https://www.fda.gov/media/191162/download?attachment. Accessed October 11, 2026.
10. American Academy of Family Physicians. Adults 19 and older immunization schedules (adopted version; page shows no version date). Accessed October 11, 2026. https://www.aafp.org/clinical-insights/immunizations-and-vaccines/immunizations-schedules-resources/adult-immunization-schedules. Accessed October 11, 2026.
11. Immunize.org. Ask the Experts: zoster (shingles), vaccine recommendations. Entries last reviewed August 25, 2025 and August 12, 2026. Accessed October 11, 2026. https://www.immunize.org/ask-experts/topic/zoster/vaccine-recommendations-zoster-shingles/. Accessed October 11, 2026.
12. Dooling KL, Guo A, Patel M, 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. Accessed October 11, 2026. https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm. Accessed October 11, 2026.
13. Centers for Disease Control and Prevention. Adult immunization schedule notes: recommendations for ages 19 years or older, United States, 2025. July 2, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-notes.html. Accessed October 11, 2026.
14. Centers for Disease Control and Prevention. Clinical considerations for use of recombinant zoster vaccine in immunocompromised adults aged 19 years and older. Page dated July 9, 2024. Accessed October 11, 2026. https://www.cdc.gov/shingles/hcp/vaccine-considerations/immunocompromised-adults.html. Accessed October 11, 2026.
15. Centers for Disease Control and Prevention. Vaccine storage and handling toolkit. Page dated July 14, 2026. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/storage-handling/index.html. Accessed October 11, 2026.
16. Centers for Disease Control and Prevention. Recombinant zoster (shingles) vaccine: what you need to know. Vaccine Information Statement, February 4, 2022. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/shingles.html. Accessed October 11, 2026.
17. Centers for Disease Control and Prevention. Adult immunization schedule appendix: guide to contraindications and precautions, United States, 2025. July 2, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-appendix.html. Accessed October 11, 2026.