Hepatitis A and B vaccine

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:

  • 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.[12] 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. Twinrix first entered the market in early 1997.[13]

In the United States, Twinrix is approved by the Food and Drug Administration (FDA) for those aged 18 and older.[3][14] 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]

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. 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. Pediatric Vaccines and Vaccinations: A European Textbook Springer, 2017^
  8. Hepatitis A and B vaccine Uses, Side Effects & Warnings Drugs.com, retrieved 27 December 2021^
  9. Hepatitis A vaccination Human Vaccines & Immunotherapeutics, July 2020^
  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^
  11. Notice to Readers: FDA Approval of an Alternate Dosing Schedule for a Combined Hepatitis A and B Vaccine (Twinrix) Centers for Disease Control and Prevention (CDC), 12 October 2007, retrieved 22 September 2019^
  12. Twinrix Food and Drug Administration (FDA), 24 April 2019, retrieved 22 September 2019^
  13. SB's Twinrix Launched In Its First Market thepharmaletter.com, 20 January 1997, retrieved 23 December 2019^
  14. FDA approval for a combined hepatitis A and B vaccine MMWR. Morbidity and Mortality Weekly Report, September 2001^
  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. Immunogenicity, effectiveness and safety of combined hepatitis A and B vaccine: a systematic literature review Expert Review of Vaccines, July 2016^