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Hepatitis A and B vaccine

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Hepatitis A and B vaccine
Combined hepatitis A and B vaccine (Twinrix)
Combination of
Hepatitis A vaccineVaccine
Hepatitis B vaccineVaccine
Clinical data
Trade namesTwinrix, Ambirix, others
AHFS/Drugs.comFDA Professional Drug Information
License data
Pregnancy
category
  • AU: B2
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
UNII

Combined hepatitis A and B vaccine, is used to provide protection against hepatitis A and hepatitis B.[3][7] It is given by injection into muscle.[8]

It is used in areas where hepatitis A and B are endemic, for travelers, people with hepatitis C or chronic liver disease, and those at high risk of sexually transmitted diseases.[7]

The combined vaccine is as safe and protective as if given as separate hepatitis A and B vaccines.[7] It is generally well-tolerated.[9] Common side effects are mild and include redness and pain at the injection site, where a small lump may appear.[8] Feeling faint or tired, or a headache may occur.[8] Other side effects include numbness, tingling, rash, bruising, abnormal bleeding such as from the nose or gums, weak muscle or pain.[8] Severe side effects are rare and include an allergic reaction and seizures.[8]

It is widely available.[7]

Administration 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]).[3][10] 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.[11]

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:[12]

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

Availability

Twinrix is a brand manufactured by GlaxoSmithKline Biologicals. The full generic name is hepatitis A inactivated & hepatitis B (recombinant) vaccine.[13] Twinrix is administered over three doses. The name 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.[citation needed] Twinrix first entered the market in early 1997.[14]

In the United States, Twinrix is approved by the Food and Drug Administration (FDA) for those aged 18 and older.[3][12] In some countries outside the United States, notably Canada and in the European Union, Twinrix is known as Twinrix Adult or Ambirix and a pediatric formulation, called Twinrix Junior or Twinrix Paediatric, is available.[15][16][17][18][19][20][21][22][excessive citations]

Society and culture

Economics

By being a combination it may reduce administrative costs and achieve a better uptake of the vaccine.[23]

Brand names

Brand names include Twinrix, Twinrix Junior, Twinrix paediatric, Ambirix,[7] and Bilive.[9]

References

  1. ^ "Twinrix Adult Vaccine, suspension for injection - Summary of Product Characteristics (SmPC)". (emc). 30 March 2021. Retrieved 12 January 2022.
  2. ^ "Twinrix Paediatric, suspension for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 20 April 2021. Retrieved 12 January 2022.
  3. ^ a b c d "Twinrix (hepatitis a and hepatitis b- recombinant vaccine injection, suspension". DailyMed. Retrieved 12 January 2022.
  4. ^ "Ambirix". European Medicines Agency. 17 September 2018. Retrieved 12 January 2022.
  5. ^ "Twinrix Adult". European Medicines Agency. 17 September 2018. Retrieved 12 January 2022.
  6. ^ "Twinrix Paediatric". European Medicines Agency. 17 September 2018. Retrieved 12 January 2022.
  7. ^ a b c d e van Damme P (2017). "12. Hepatitis A vaccines". In Vesikari T, van Damme P (eds.). Pediatric Vaccines and Vaccinations: A European Textbook. Switzerland: Springer. p. 107. ISBN 978-3-319-59950-2.
  8. ^ a b c d e "Hepatitis A and B vaccine Uses, Side Effects & Warnings". Drugs.com. Retrieved 27 December 2021.
  9. ^ a b Zhang L (July 2020). "Hepatitis A vaccination". Human Vaccines & Immunotherapeutics. 16 (7): 1565–1573. doi:10.1080/21645515.2020.1769389. PMC 7482852. PMID 32649265.
  10. ^ "Recommended Adult Immunization Schedule for ages 19 years or older, United States, 2019". Centers for Disease Control and Prevention (CDC). 5 February 2019. Retrieved 22 September 2019.Public Domain This article incorporates text from this source, which is in the public domain.
  11. ^ "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. Retrieved 22 September 2019.
  12. ^ a b "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.
  13. ^ "Twinrix". Food and Drug Administration (FDA). 24 April 2019. Retrieved 22 September 2019.
  14. ^ "SB's Twinrix Launched In Its First Market". thepharmaletter.com. 20 January 1997. Retrieved 23 December 2019.
  15. ^ "Twinrix Adult Vaccine SmPC". Datapharm. 8 October 2018.
  16. ^ "Twinrix Paediatric Vaccine SmPC". Datapharm. 8 October 2018.
  17. ^ "Ambirix SmPC". Datapharm. 5 November 2018.
  18. ^ "Hepatitis A Vaccine: Canadian Immunization Guide". Public Health Agency of Canada. 2018-03-13. Retrieved 22 September 2019.
  19. ^ "Twinrix (720/20)". The Australian Immunisation Handbook. 4 June 2018. Retrieved 22 September 2019.
  20. ^ "Twinrix (720/20)". The Australian Immunisation Handbook. August 3, 2021. Retrieved 22 September 2019.
  21. ^ "Twinrix Junior (360/10)". The Australian Immunisation Handbook. 4 June 2018. Retrieved 22 September 2019.
  22. ^ "Twinrix Junior (360/10)". The Australian Immunisation Handbook. August 3, 2021. Retrieved 22 September 2019.
  23. ^ Bakker M, Bunge EM, Marano C, de Ridder M, De Moerlooze L (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. PMID 26840060. S2CID 3349582.
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