SHINGRIX

What it is

SHINGRIX is a recombinant Varicella Zoster Virus glycoprotein E antigen (AS01B adjuvanted vaccine) supplied as powder and suspension for suspension for injection. After reconstitution, one dose (0.5 mL) contains 50 micrograms of gE antigen adjuvanted with AS01B. SHINGRIX is for intramuscular injection only, preferably in the deltoid muscle.

Approved indications

SHINGRIX is indicated for the prevention of herpes zoster (HZ) and post-herpetic neuralgia in: — Adults 50 years of age or older. — Adults 18 years of age or older at increased risk of HZ.

Dosing overview

The primary vaccination schedule consists of two doses of 0.5 mL each; an initial dose followed by a second dose 2 to 6 months later. For subjects who are immunodeficient, immunosuppressed or likely to become immunosuppressed due to known disease or therapy, and who would benefit from a shorter vaccination schedule, the second dose can be given 1 to 2 months after the initial dose. The need for booster doses has not been established.

Key safety warnings

An increased risk of Guillain-Barré syndrome has been observed following vaccination with SHINGRIX. In post-marketing observational studies in individuals aged 65 years or older, an increased risk of Guillain-Barré syndrome (estimated 3 to 7 excess cases per million doses administered) was observed during the 42 days following any dose of SHINGRIX, with the increased risk observed following the first dose (estimated 6 to 12 excess cases per million doses administered), but no increased risk observed following the second dose. SHINGRIX should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection, and it is important that procedures are in place to prevent injury from faints and to manage syncopal reactions.

Contraindications

SHINGRIX is contraindicated in patients with hypersensitivity to the active substances or to any component of the vaccine.

Regulatory history

SHINGRIX was first listed on the Australian Register of Therapeutic Goods on 2 July 2018. The Pharmaceutical Benefits Scheme Advisory Committee recommended against listing in November 2017 due to uncertain cost-effectiveness and clinical benefit in the proposed population. In March 2023, the Committee recommended against listing for prevention of herpes zoster and post-herpetic neuralgia in non-Indigenous individuals aged 65 to 69 years and individuals aged 71 years and older. In July 2023, SHINGRIX was recommended for listing for prevention of herpes zoster and post-herpetic neuralgia. In November 2023, SHINGRIX was recommended for listing as a designated vaccine for prevention of herpes zoster and post-herpetic neuralgia for individuals aged 18–64 years at moderate to high risk of infection, being cost-effective at the requested cost per dose.