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Visit our COVID-19 website for more information

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Visit our influenza website for more information

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Overview

Shingrix® is approved for use for the prevention of herpes zoster (shingles) and herpes zoster complications such as post herpetic neuralgia (PHN) in adults aged over 50 years. PHN is a debilitating and painful condition, particularly in older people. Two doses are funded at age 65 years. It is recommended, but not funded, for all individuals aged from 50 years. It is particularly recommended for individuals have an increased risk of zoster and zoster complications and for those who have contraindications to the live zoster vaccine (Zostavax). The effectiveness of this vaccine does not decrease when given to older age groups (with an efficacy of around 90% against zoster and PHN), so those aged over 70 years will also be protected and a high level of protection (over 80%) has been shown to be maintained for more than seven years, so far.

Shingrix is an adjuvanted subunit vaccine that contains recombinant VZV glycoprotein E (gE). Unlike the live attenuated zoster vaccine, Zostavax, it is a non-live vaccine that is recommended for adults from the age of 18 years and above who are at increased risk of shingles. The proprietary adjuvant (AS01B) enhances the neutralising antibody and specific T cells responses against VZV.

Responses to vaccine

Shingrix
Common reponses
  • Injection-site pain and swelling
  • Myalgia
  • Fatigue
  • Headache
  • Shivering
  • Fever
  • Gastrointestinal symptoms (nausea, vomiting, diarrhoea)
Rare responses
  • Hypersensitivity - rashes and hives, angioedema.

In Depth

Other brands: formerly available for protection against zoster is a live attenuated zoster vaccine - Zostavax. The vaccine is being discontinued.

Shingrix is approved for the prevention of herpes zoster (shingles) and its associated complications, including post herpetic neuralgia (PHN). Although a live attenuated zoster vaccine Zostavax, is funded at the age of 65 years, many adults have medical conditions that increase their risk for zoster or are, with advancing age, at higher risk of PHN and other debilitating complications associated with zoster. It can be purchased for these groups from the age of 18 years.

Two doses of Shingrix are recommended and funded at the age of 65 years.

Two doses of Shingrix are recommended but not funded for all individuals aged from 50 years, including those aged 66 years or over; and for individuals aged from 18 years who are at increased risk of zoster, including:

  • prior to planned, receiving or post immunosuppressive therapy
  • with living with HIV infection
  • with end-stage kidney disease (CKD stages 4–5)
  • prior to or post solid organ transplantation
  • prior to or post HSCT
  • with immune-mediated inflammatory disease receiving immunomodulatory agents (eg, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, Crohn’s disease, ulcerative colitis).

Other conditions that can increase risk of zoster in older adults, include:

  • diabetes
  • chronic obstructive pulmonary disease
  • chronic inflammatory skin diseases
  • splenectomy
  • chronic pancreatitis
  • psychiatric disorders, including depression and anxiety
  • sleep disorders.

Two doses are given two to six months apart.

Shingrix may be offered to individuals who previously had Zostavax (live zoster vaccine) and/or has a history of zoster episodes. Allow 12 months between Zostavax or after an episode of zoster has resolved before giving Shingrix. There are no safety concerns around giving it sooner but since the immune system will have been activated against the varicella-zoster virus by these events, there is likely to be little additional short-term benefit. This may be shortened to at least three months for those who are immunocompromised with the highest risk of zoster recurrence.

Storage and preparation

Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light.

Administration

Give two doses, the second dose is given 2 to 6 months after the first. The vaccine should be administered intramuscularly, only. The preferred site is into the deltoid muscle.

Shingrix can be administered concurrently with other vaccines, including all National Immunisation Schedule vaccines, such as 23PPV and Tdap. Separate syringes and different injection sites should be used.

The safety and efficacy of administering two liposomal adjuvanted vaccines together is not yet established. Shingrix, Fluad Quad (adjuvanted seasonal influenza vaccine) and Nuvaxovid (adjuvanted recombinant COVID-19 vaccine) may be given on the same day, at different injection-sites, if necessary, but it is preferable to allow 3 days between them or once any potential reactions have resolved.

There are currently no recommendations around giving further doses or booster doses.

Vaccine Safety

Shingrix should not be given to:

  • Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or a component of the vaccine
  • Administration of Shingrix should be postponed in individuals suffering from a fever over 38°C. The presence of a minor infection is not a reason to delay immunisation

Specialist advice should be sought for the following groups:

This vaccine is for intramuscular injection only.

For those with bleeding disorders, such as haemophilia or thrombocytopenia, the vaccine should be administered in accordance with the haematologist’s instructions.

The Shingrix datasheet from Medsafe can be found here.

Vaccine Effectiveness

During phase 3 clinical trials (ZOE-50 and ZOE-70), Shingrix had efficacy against both zoster and associated complications of over 90 percent efficacy in adults aged over 50 years, including those aged from 70 years and those with medical conditions that increase their risk of zoster. Pooled vaccine efficacy was 91% (95% CI 87-95) against the incidence of zoster overall and 91% (86-98% against post-herpetic neuralgia across all age groups. No decline was observed in increased age with efficacy of 91% (80-97) against zoster in those aged over 80 years.

Ongoing long-term follow-up of these trial participants found efficacy against zoster plateaued after four to six years and was sustained overall at 84 percent for at least seven years post-vaccination.

Post hoc analysis found the efficacy of Shingrix against zoster remained over 90% in participants with select medical conditions (eg. hypertension, diabetes, coronary heart disease, respiratory disorders). Other studies have investigated the use of Shingrix in participants aged from 18 years with severely immunocompromising conditions. Vaccine efficacy of 68.2% (95% CI 55.6-77.5%) was seen for HSCT recipients, 87.2% (44.3-98.6%) in patients with haematological malignancies and 90.5% (73.5-97.5%) for immune-mediated diseases (including psoriasis, rheumatoid arthritis and spondyloarthropathy). Efficacy against post herpetic neuralgia was 89% (22-100%) and against zoster-related hospitalisation was 85% (32-97%) in patients following HSCT.

Real world effectiveness of two doses of Shingrix against zoster of 70.1% (68.6-71.5) was shown in an observational study in the US in Medicare beneficiaries aged 65 years or older. Similar effectiveness was seen for those aged over 80 years, from six or more months after vaccination and for those with autoimmune conditions. Effectiveness of two doses against post-herpetic neuralgia was 76.0% (68.4-84.8). The lower effectiveness compared with clinical trials was likely due to how zoster was notified in clinical notes as ‘suspected cases’ rather than being PCR-confirmed as in clinical trials.

References

  • Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. NEJM. 2016;375(11):1019-32.
  • Oostvogels L, Heineman TC, Johnson RW, Levin MJ, McElhaney JE, Van den Steen P, et al. Medical conditions at enrolment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials. Hum Vacc Immunother. 2019;15(12):2865-72.
  • Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. NEJM. 2015;372(22):2087-96.
  • Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu CJ, Andrews C, et al. The adjuvanted recombinant zoster vaccine confers long-term protection against herpes zoster: Interim results of an extension study of the pivotal phase III clinical trials (ZOE-50 and ZOE-70). Clin Inf Dis. 2021.
  • Anderson TC, Masters NB, Guo A, Shepersky L, Leidner AJ, Lee GM, et al. Use of recombinant zoster vaccine in Immunocompromised adults aged ≥19 Years: recommendations of the Advisory Committee on Immunization Practices - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(3):80-4.
  • Racine E, Gilca V, Amini R, Tunis M, Ismail S, Sauvageau C. A systematic literature review of the recombinant subunit herpes zoster vaccine use in immunocompromised 18-49 year old patients. Vaccine. 2020;38(40):6205-14.
  • Izurieta HS, Wu X, Forshee R, et al. Recombinant Zoster Vaccine (Shingrix): Real-world effectiveness in the first 2 years post-licensure. Clin Infect Dis. 2021;73(6):941-8.
  • Ministry of Health. Immunisation handbook [Internet]. Wellington: Ministry of Health; 2020 [updated 2022 February 17; cited 2022 February 21]. Available from: https://www.health.govt.nz/publication/immunisation-handbook-2020
  • Schwarz TF, Aggarwal N, Moeckesch B, Schenkenberger I, Claeys C, Douha M, et al. Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2017;216(11):1352-61.
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