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]

Hepatitis A and B vaccine

Combined hepatitis A and B vaccine (Twinrix)
Combination of
Hepatitis A vaccine	Vaccine
Hepatitis B vaccine	Vaccine
Clinical data
Trade names	Twinrix, Ambirix, others
AHFS/Drugs.com	FDA Professional Drug Information
License data	US DailyMed: Hepatitis A and hepatitis A
Pregnancy category	AU: B2
Routes of administration	Intramuscular
ATC code	J07BC20 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) UK: POM (Prescription only)^[1]^[2] US: ℞-only^[3] EU: Rx-only^[4]^[5]^[6]
Identifiers
CAS Number	467420-42-4^Y
ChemSpider	none
UNII	5BFC8LZ6LQ

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. "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. 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. "Hepatitis A and B vaccine Uses, Side Effects & Warnings". Drugs.com. Retrieved 27 December 2021.
9. 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.  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. "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.