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Shingrix

Common name:

adjuvanted recombinant zoster vaccine (rZV)

Protects against herpes zoster (shingles) and associated complications like post herpetic neuralgia.

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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. 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 can be given to people who are immunocompromised or receiving immunosuppressive treatments. The proprietary adjuvant (AS01B) enhances the neutralising antibody and specific T cells responses against VZV.

Please see the below links for more information.

  • Shingrix datasheet from Medsafe here
  • Medsafe alphabetical listing of datasheets here

Responses to vaccine

Shingrix
Common responses
  • Injection-site pain and swelling
  • Myalgia
  • Fatigue
  • Headache
  • Shivering
  • Fever
  • Gastrointestinal symptoms (nausea, vomiting, diarrhoea)
Rare responses
  • Hypersensitivity - rashes and hives, angioedema.
As with any medicine, very rarely a severe allergic reaction (anaphylaxis) can occur following immunisation.

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.
In Depth

Other brands: also available for protection against zoster is a live attenuated zoster vaccine - Zostavax

Vaccine type: adjuvanted subunit protein vaccine

Schedule and administration

Shingrix is approved for the prevention of herpes zoster (shingles) and its associated complications, including post herpetic neuralgia (PHN). It may be purchased by adults aged from 50 years. 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.

Two doses of recombinant ZV are recommended but not funded for individuals aged from 50 years:

  • who are at increased risk of zoster
  • who may benefit from being vaccinated earlier than the routine schedule or have contraindications to live ZV:
    • prior to planned, receiving or post immunosuppressive therapy
    • 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(eg, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, Crohn’s disease, ulcerative colitis)
    • a first-degree relative with a history of zoster
    • with depression
    • with diabetes
    • with psychiatric disorders
    • with chronic obstructive pulmonary disease
  • Personal preference for those aged from 65 years

Older adults over the age of 65 years are also recommended two doses of Shingrix to provide longer lasting protection.

Shingrix may be offered to individuals who previously had Zostavax 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 for most people. Shingrix can be given sooner, from 3 months after a zoster episode has resolved or prior Zostavax dose, for individuals who are immunocompromised and at increased risk of zoster recurrence.

Although Shingrix is not approved for use in under the age of 50 years in New Zealand, in situations where a specialist has recommended an adult aged 18 to 50 years to receive Shingrix, an authorised prescriber / general practitioner can provide a prescription for off-label use.

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 preferrable 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:

Those with bleeding disorders, such as haemophilia or thrombocytopenia. The vaccine should be administered in accordance with the haematologist’s instructions. This vaccine is for intramuscular injection only.

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. (Note, Shingrix is not yet approved for use in New Zealand under the age of 50 years).

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.

Last updated: Aug 2022