Shingrix is approved for the prevention of herpes zoster (shingles) and its associated complications, including post herpetic neuralgia (PHN).

Two doses of Shingrix given two to six months apart are 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 and over; and for individuals aged from 18 years who are at increased risk of zoster, including:

• prior to planned, receiving or post immunosuppressive therapy
• 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.

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. Those with ophthalmic shingles should wait until 12 months of disease quiescence (has completely settled) before having a Shingrix dose.

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 adjuvanted vaccines together is not yet established. Shingrix, Fluad Quad (adjuvanted seasonal influenza vaccine) and Nuvaxovid (adjuvanted recombinant COVID-19 vaccine) utilise novel adjuvants to gain a good immune response. Patients should be informed of the possibility of a stronger post-vaccination response, where two or more of these are administered together.

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

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.

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.

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