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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