PreHevbri®
Hepatitis B vaccine (recombinant, adsorbed) PreHevbri® is the first 3-antigen hepatitis B vaccine available in Great Britain (GB). Help protect your adult travellers, higher-risk professionals and individuals against hepatitis B.
Key facts
- PreHevbri® is licensed for immunisation against all known subtypes of the Hepatitis B virus in adults (≥ 18 years)1
- Up to 10% of adults don’t respond to yeast-derived single-antigen hepatitis B vaccines2,3
- PreHevbri® is designed to improve immunogenicity and is the only 3-antigen vaccine for hepatitis B currently available in Great Britain3
- It has demonstrated a seroprotection rate >90%4,5
- PROTECT study (n = 1607) Seroprotection rate was 91.4% for PreHevbri® vs 76.5% with a single antigen vaccine, 4 weeks after the third vaccination (Day 196) in ≥18-year-old participants4
- CONSTANT study (n = 2838) Seroprotection rate was 99.3% for PreHevbri® vs 94.8% for a single antigen vaccine, 4 weeks after the third vaccination (Day 196) in 18 – 45-year-old participants5
- PreHevbri® shows favourable seroprotection rates regardless of age, BMI or diabetes4
- It is administered as a three-dose schedule (1 mL each)1
- First dose on day 0, second dose one month after the first dose, and third dose 6 months after the first dose
- PreHevbri® is generally well-tolerated3
- The most common adversere actions(≥1/10) include injection site pain and tenderness, fatigue, headache and myalgia1
- PreHevbri® is contraindicated in individuals who have had an anaphylactic or other severe allergic reaction to any hepatitis B vaccine or have any hypersensitivity to the active substance or any excipients of PreHevbri®.1 Vaccination is only recommended during pregnancy if the benefits outweighs the possible risks for the foetus.1
How you should administer PreHevbri®
PreHevbri® is an injectable suspension, supplied in a single-dose vial. A series of three injections are given over six months. PreHevbri® should only be injected intramuscularly into the deltoid region.1
View Prescribing Information for PREHEVBRI®– For HCPs in Great Britain (GB) only.Further information on SMPC Further information on PIL
References
- PreHevbri suspension for injection. Summary of Product Characteristics. March 2023. Available online: medicines.org.uk. Accessed June 2023.
- Centers for Disease Control and Prevention. Prevention of Hepatitis B virus infection in the United States: Recommendation of the advisory committee on immunization practices. MMWR 2018:67(1):1–31. Available online: cdc.gov. Accessed March 2023.
- European Medicines Agency. PreHevbri: EPAR – Public Assessment Report. March 2023. Available online: ema.europa.eu. Accessed June 2023.
- Vesikari T, Langley JM, Segall N, et al. Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase 3 trial. Lancet Infect Dis. 2021;21(9):1271-81.
- Vesikari T, Finn A, van Damme P, et al. CONSTANT study group. Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2021;4(10):e212865.
Adverse events should be reported.
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to the Valneva UK Ltd Medical Information department on Tel: +43 1 20620 1400 or via email: vaccinesafety@valneva.com
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to the Valneva UK Ltd Medical Information department on Tel: +43 1 20620 1400 or via email: vaccinesafety@valneva.com