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.
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:
Other conditions that can increase risk of zoster in older adults, include:
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.
Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light.
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.
Shingrix should not be given to:
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.