Combined hepatitis A and B vaccine

Combined hepatitis A and B vaccine
Combination hepatitis A and B vaccine (Twinrix) for children
Combination of
Hepatitis A vaccineVaccine
Hepatitis B vaccineVaccine
Names
Trade namesTwinrix, Ambirix, Twinrix paediatric,[1] Bilive[2]
Clinical data
Main usesPrevent hepatitis A and B[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
  • AU: B2
    Routes of
    use
    Intramuscular injection
    External links
    AHFS/Drugs.comFDA Professional Drug Information
    Legal
    License data
    Legal status

    Combined hepatitis A and B vaccine, prevents both hepatitis A and hepatitis B.[1] It is given by injection into muscle.[3] Depending on the brand, either two or three doses are used.[1]

    It is useful where risk factors overlap; in areas where hepatitis A and B are common, for travellers, people with hepatitis C or chronic liver disease, and those at high risk of sexually transmitted infections.[1] If there has previously been a severe allergic reaction to a hepatitis A or B vaccine, yeast or neomycin, then the combined vaccine is not recommended.[3]

    The combined is as safe and protective as if given as separate hepatitis A and B vaccines.[1] It is generally well-tolerated.[2] Common side effects include redness and pain at the injection site, where a small lump may appear.[3] Feeling faint or tired, or a headache may occur.[3] Other side effects may include numbness, tingling, rash, bruising, abnormal bleeding such as from the nose or gums, weak muscle, or pain.[3] Severe side effects are rare and include an allergic reaction and seizures.[3]

    The combination was approved for medical use in the United States in 2001.[4] It is widely available.[1] By being a combination it may reduce administrative costs and achieve a better uptake of the vaccine.[5] In the UK, both Twinrix and Ambrix cost the NHS around £31 per dose.[6]

    Medical uses

    Efficacy

    The U.S. Centers for Disease Control and Prevention (CDC) reports that clinical trials found the following levels of protection against Hepatitis A and Hepatitis B one month after each dose:[7]

    A: 93.8%, 98.8%, 99.9%
    B: 30.8%, 78.2%, 98.5%

    GlaxoSmithKline claims that its studies found 70% of subjects had antibodies against hepatitis B a month after just the first dose, however.[8]

    Twinrix should not be used for postexposure prophylaxis, because no data are available on the efficacy of combination vaccine for prophylaxis after exposure to HAV.[9]

    Schedule

    Routine Twinrix vaccination is administered by intramuscular injection in the deltoid area using a schedule of three separate doses at 0, 1, and 6 months ([minimum intervals: 4 weeks between doses 1 and 2, 5 months between doses 2 and 3]).[10][11] In some circumstances, an accelerated dosing schedule of 0, 7 and 21 to 30 days followed by a booster at 12 months can be used and was shown to have similar efficacy as the traditional schedule.[12]

    Society and culture

    Availability

    In the United States, Twinrix is approved by the Food and Drug Administration (FDA) for those aged 18 and older.[7] In some countries outside the United States, notably Canada and Europe, Twinrix is known as Twinrix Adult or Ambirix and a pediatric formulation, called Twinrix Junior or Twinrix Paediatric, is available.[8][13][14][15][16][17]

    Naming

    The name Twinrix was created because it is a mixture of two earlier vaccines — Havrix, an inactivated-virus Hepatitis A vaccine, and Engerix-B, a recombinant Hepatitis B vaccine. Twinrix first entered the market in early 1997.[18]

    References

    1. 1 2 3 4 5 6 7 Damme, Pierre Van; Hendricks, Greet (2021). "12. Hepatitis A vaccines". In Vesikari, Timo; Damme, Pierre Van (eds.). Pediatric Vaccines and Vaccinations: A European Textbook (Second ed.). Switzerland: Springer. pp. 115–126. ISBN 978-3-030-77172-0. Archived from the original on 11 January 2022. Retrieved 30 December 2021.
    2. 1 2 Zhang, Li (2 July 2020). "Hepatitis A vaccination". Human Vaccines & Immunotherapeutics. 16 (7): 1565–1573. doi:10.1080/21645515.2020.1769389. ISSN 2164-5515. PMID 32649265. Archived from the original on 28 December 2021. Retrieved 27 December 2021.
    3. 1 2 3 4 5 6 "Hepatitis A and B vaccine Uses, Side Effects & Warnings". Drugs.com. Archived from the original on 28 December 2021. Retrieved 27 December 2021.
    4. "DailyMed - TWINRIX (hepatitis a and hepatitis b- recombinant vaccine injection, suspension". dailymed.nlm.nih.gov. Archived from the original on 17 April 2021. Retrieved 28 December 2021.
    5. Bakker, Marina; Bunge, Eveline M.; Marano, Cinzia; de Ridder, Marc; De Moerlooze, Laurence (July 2016). "Immunogenicity, effectiveness and safety of combined hepatitis A and B vaccine: a systematic literature review". Expert Review of Vaccines. 15 (7): 829–851. doi:10.1586/14760584.2016.1150182. ISSN 1744-8395. PMID 26840060. Archived from the original on 2021-12-28. Retrieved 2021-12-27.
    6. "14. Vaccines". British National Formulary (BNF) (82 ed.). London: BMJ Group and the Pharmaceutical Press. September 2021 – March 2022. pp. 1383–1384. ISBN 978-0-85711-413-6.{{cite book}}: CS1 maint: date format (link)
    7. 1 2 "FDA approval for a combined hepatitis A and B vaccine" (PDF). MMWR. Morbidity and Mortality Weekly Report. 50 (37): 806–7. September 2001. PMID 11785573. Archived (PDF) from the original on 2021-11-05. Retrieved 2021-12-26.
    8. 1 2 "Twinrix Adult Vaccine SmPC". Datapharm. 8 October 2018. Archived from the original on 27 December 2021. Retrieved 26 December 2021.
    9. "Hepatitis A - Chapter 4 - 2020 Yellow Book - Travelers' Health". Centers for Disease Control and Prevention (CDC). 1 July 2019. Archived from the original on 23 September 2019. Retrieved 22 September 2019.Public Domain This article incorporates text from this source, which is in the public domain.
    10. "Package Insert - TWINRIX" (PDF). Food and Drug Administration (FDA). Archived from the original on 6 December 2019. Retrieved 22 September 2019.
    11. "Recommended Adult Immunization Schedule for ages 19 years or older, United States, 2019". Centers for Disease Control and Prevention (CDC). 5 February 2019. Archived from the original on 21 July 2020. Retrieved 22 September 2019.Public Domain This article incorporates text from this source, which is in the public domain.
    12. "Notice to Readers: FDA Approval of an Alternate Dosing Schedule for a Combined Hepatitis A and B Vaccine (Twinrix)" (PDF). Centers for Disease Control and Prevention (CDC). 12 October 2007. Archived (PDF) from the original on 17 October 2020. Retrieved 22 September 2019.
    13. "Twinrix Paediatric Vaccine SmPC". Datapharm. 8 October 2018. Archived from the original on 7 May 2021. Retrieved 26 December 2021.
    14. "Ambirix SmPC". Datapharm. 5 November 2018. Archived from the original on 3 March 2020. Retrieved 26 December 2021.
    15. "Hepatitis A Vaccine: Canadian Immunization Guide". Public Health Agency of Canada. 2018-03-13. Archived from the original on 2019-09-23. Retrieved 22 September 2019.
    16. "Twinrix (720/20)". The Australian Immunisation Handbook. 4 June 2018. Archived from the original on 25 March 2020. Retrieved 22 September 2019.
    17. "Twinrix Junior (360/10)". The Australian Immunisation Handbook. 4 June 2018. Archived from the original on 25 March 2020. Retrieved 22 September 2019.
    18. "SB's Twinrix Launched In Its First Market". thepharmaletter.com. 20 January 1997. Archived from the original on 23 December 2019. Retrieved 23 December 2019.
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