Form: Suspension for injection, 50 mcg Varicella Zoster Virus (VZV) glycoprotein E (gE)
Manufacturer: GlaxoSmithKline Inc.
Indications and Clinical Use
Indication:
Prevention of herpes zoster (HZ, or shingles) in adults 50 years of age or older.
Adults 18 years of age or older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.
Dosage and Administration
Recommended Dose: Two doses of 0.5 mL each, administered intramuscularly.
Initial dose at Month 0.
Second dose administered anytime between 2 and 6 months later.
For individuals who are immunodeficient or immunosuppressed, the second dose can be given 1 to 2 months after the initial dose.
Reconstitution:
Reconstitute with the accompanying adjuvant suspension.
Shake gently until completely dissolved.
Inspect for any foreign particulate matter or variation in appearance.
Use promptly; store in a refrigerator if not used immediately.
Contraindications
Known hypersensitivity to any component of the vaccine.
Warnings and Precautions
General: Review medical history and conduct a clinical examination before vaccination. Be prepared for anaphylactic events.
Special Populations:
Pregnant Women: No data available.
Breastfeeding: Effects on breast-fed infants not studied.
Pediatrics: Safety and efficacy not established for individuals under 18 years.
Geriatrics: Safety and efficacy assessed in clinical trials for individuals 60 years and older.
Adverse Reactions
Very Common: Injection site pain, redness, and swelling; myalgia; fatigue; headache; shivering; fever; gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain).
Serious: Rare cases of anaphylaxis and Guillain-Barré syndrome have been observed post-market.
Drug Interactions
Can be administered concomitantly with unadjuvanted seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23), or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (Tdap), at different injection sites.
Storage and Stability
Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light.
Use reconstituted vaccine promptly or store in a refrigerator and use within 6 hours.
Clinical Trials and Efficacy
Efficacy Studies: ZOE-50 and ZOE-70 studies demonstrated significant reduction in the risk of developing herpes zoster in adults 50 years and older.
Overall Efficacy: 97.2% reduction in HZ incidence in subjects aged 50 years and older.
Efficacy in Subjects 70 Years and Older: 91.3% reduction in HZ incidence.
Immunogenicity: Strong and persistent antibody response observed, with vaccine efficacy maintained through 4 years post-vaccination.
