Zoster Vaccine, Recombinant

What it is and how it works

Contains recombinant varicella-zoster virus glycoprotein E combined with the AS01B adjuvant system. It induces strong gE-specific CD4+ T-cell and antibody responses, boosting immunity against reactivation of latent varicella-zoster virus; it contains no live virus and can be given to immunocompromised individuals.

Indications

Prevention of herpes zoster (shingles) and post-herpetic neuralgia in adults aged 50 years and over, and in adults aged 18 years and over at increased risk of herpes zoster.

Dosage and administration (summary)

Two doses of 0.5 mL by intramuscular injection, the second given 2–6 months after the first (1–2 months in individuals who are or will be immunosuppressed).

Contraindications

Hypersensitivity to the active substance or any component.

Warnings and precautions

Not indicated for the treatment of herpes zoster or post-herpetic neuralgia, or for prevention of primary varicella. Local and systemic reactogenicity (pain, myalgia, fatigue, fever) is common for 2–3 days. Give with caution to patients with thrombocytopenia or coagulation disorders; syncope may occur; a small increased risk of Guillain–Barré syndrome has been reported.

Pregnancy

Avoid in pregnancy as a precaution owing to lack of data.

Storage and supply

Store refrigerated at 2–8 °C, protected from light; do not freeze.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.