Hepatitis A vaccine
Havrix junior monodose (hepatitis A) for children
Vaccine description
TargetHepatitis A virus
Vaccine typeInactivated or attenuated
Clinical data
Trade namesBiovac A, Havrix, Vaqta, others
AHFS/Drugs.comMonograph
MedlinePlusa695003
Pregnancy
category
  • AU: B2
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
Identifiers
DrugBank
ChemSpider
  • none
UNII
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Hepatitis A vaccine is a vaccine that prevents hepatitis A.[1][2] It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life.[3] If given, two doses are recommended beginning after the age of one.[1] It is given by injection into a muscle.[1] The first hepatitis A vaccine was approved in Europe in 1991, and the United States in 1995.[4] It is on the World Health Organization's List of Essential Medicines.[5][6]

The World Health Organization (WHO) recommends universal vaccination in areas where the disease is moderately common.[1] Where the disease is very common, widespread vaccination is not recommended as all people typically develop immunity through infection during childhood.[1] The Centers for Disease Control and Prevention (CDC) recommends vaccinating:

  • All children aged 12–23 months
  • Unvaccinated children and adolescents aged 2–18 years
  • International travelers
  • People who use injection or non-injection drugs
  • People who have occupational risk for infection
  • People who anticipate close contact with an international adoptee
  • People experiencing homelessness
  • People with HIV
  • People with chronic liver disease
  • Any person wishing to obtain immunity[7]

In addition, a person who has not previously received hepatitis A vaccine and who has direct contact with someone with hepatitis A should get hepatitis A vaccine within two weeks after exposure.[7]

Severe side effects are very rare.[1] Pain at the site of injection occurs in about 15% of children and half of adults.[1] Most hepatitis A vaccines contain inactivated virus while a few contain weakened virus.[1] The ones with weakened virus are not recommended during pregnancy or in those with poor immune function.[1] A few formulations combine hepatitis A with either hepatitis B or typhoid vaccine.[1]

Soreness or redness where the shot is given, fever, headache, tiredness, or loss of appetite can happen after hepatitis A vaccine. As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.[7]


Medical uses

Within the U.S., the vaccine "Vaqta" developed by Maurice Hilleman and his team at Merck & Co. was licensed in 1995.[8][9][10] The vaccine was phased in, around 1996, for children living in high-risk areas. In 1999, its usage was spread to areas with elevating levels of infection. In the U.S. as of 2007, the vaccine is strongly recommended for all children 12 to 23 months of age in an attempt to eradicate the virus nationwide. Although the original Food and Drug Administration (FDA) license for Havrix by GlaxoSmithKline is dated in 1995,[11] it had been approved in Europe in 1991.[4][12]

The U.S. Centers for Disease Control and Prevention (CDC), recommends vaccination of all children over one year of age, people whose sexual activity puts them at risk, people with chronic liver disease, people who are being treated with clotting factor concentrates, people working in close proximity to the virus, and people who are living in communities where an outbreak is present.[13] Hepatitis A is the most common vaccine-preventable virus acquired during travel,[14] so people traveling to places where the virus is common like the Indian subcontinent, Africa, Central America, South America, Asia, and Eastern Europe should be vaccinated.[13][15]

The vaccine is given in the muscle of the upper arm, in two doses for the best protection. The initial dose of the vaccine should be followed up by a booster six to twelve months later.[13] Protection against hepatitis A begins approximately two to four weeks after the initial vaccination.[13][15] Protection lasts at least 15 years and is estimated to last at least 25 years if the booster is administered.[16]

A Cochrane review found that both types of vaccines offer significant protection, for at least two years using the inactivated vaccine and at least five years with the attenuated vaccine. The review concluded that the inactivated vaccine is safe, but required more high quality evidence to assess the safety of the attenuated vaccine.[17]

Commercial vaccines

Havrix vaccine

Several commercial hepatitis A vaccines are available. The definition of (U)nits varies among manufacturers depending on how hepatitis A antigen is measured in their products.

  • Avaxim: made by Sanofi Pasteur. Inactivated hepatitis A virus produced in MRC-5 cells. Each dose contains 160 U of antigen adsorbed on aluminium hydroxide (0.3 mg Al).[18]
  • Epaxal: made by Crucell. Also sold under the brand names HAVpur and VIROHEP-A. This vaccine consists of virosomes, artificial particles composed of synthetic lipids and influenza proteins in addition to the hepatitis A antigen. It does not contain aluminium.[19]
  • Havrix: made by GlaxoSmithKline. Inactivated hepatitis A virus produced in MRC-5 cells. Each adult dose contains 1440 ELISA units of viral antigen adsorbed on aluminium hydroxide (0.5 mg Al). The pediatric (child) doses contain half the amount of viral antigen and aluminium.[20]
  • Healive: made by Sinovac. Inactivated hepatitis A virus cultured in human diploid cell, followed by harvest, purification, inactivation, and aluminium adsorption. Each adult dose contains 500 U of viral antigen. The pediatric dose contains 250 U of viral antigen.
  • Vaqta: made by Merck. Inactivated hepatitis A virus produced in MRC-5 cells. An adult dose contains 50 U of antigen adsorbed onto 0.45 mg of aluminium (as aluminium hydroxyphosphate sulfate); a child dose contains half the amounts of antigen and aluminium.[21]
  • Biovac-A: made by Pukang, sold under the brand name Biovac-A in India and under the brand names Mevac-A in Guatemala, Philippines, Bangladesh, Nepal, Uzbekistan and Chile etc. It is a freeze-dried live attenuated hepatitis A vaccine. Hepatitis A virus H2 strain is produced in human diploid cells. A pack of 0.5ml vial of Biovac-A and 0.5ml ampoule of SWFI (sterile water for injection), contains not be less than 6.5 Lg CCID50. Only a single dose is needed. It is recommended by the WHO. Long term persistence research data predicated that sero-conversion remained and antibody titre was not less than 128 IU/ml, 15 years after vaccination.

Combination vaccines

References

  1. 1 2 3 4 5 6 7 8 9 10 World Health Organization (2012). "WHO position paper on hepatitis A vaccines – June 2012". Weekly Epidemiological Record. 87 (28/29): 261–76. hdl:10665/241938. PMID 22905367.
  2. ↑ World Health Organization (2022). "WHO position paper on hepatitis A vaccines – October 2022". Weekly Epidemiological Record. 97 (40): 493–512. hdl:10665/363397.
  3. ↑ "Hepatitis a Q&As for Health Professionals | CDC". 19 January 2022.
  4. 1 2 Patravale V, Dandekar P, Jain R (2012). Nanoparticulate drug delivery perspectives on the transition from laboratory to market (1. publ. ed.). Oxford: Woodhead Pub. p. 212. ISBN 9781908818195.
  5. ↑ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  6. ↑ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
  7. 1 2 3 "Hepatitis A Vaccine Information Statement". Centers for Disease Control and Prevention (CDC). October 2021. Retrieved 13 July 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ↑ "Hepatitis A: Vaccine Licensed | History of Vaccines". historyofvaccines.org. Retrieved 6 February 2021.
  9. ↑ Tulchinsky TH (2018). "Maurice Hilleman: Creator of Vaccines That Changed the World". Case Studies in Public Health: 443–470. doi:10.1016/B978-0-12-804571-8.00003-2. ISBN 9780128045718. PMC 7150172.
  10. ↑ "Materials Documenting the Contribution of Dr. Maurice Hilleman to the Millennium Time Capsule Ceremony". National Museum of American History. Retrieved 14 February 2021.
  11. ↑ "Hepatitis A Vaccine Information". Vaccine Information. ImmunizationInfo. Archived from the original on 30 June 2007. Retrieved 19 June 2008.
  12. ↑ "Hepatitis A Vaccine - an overview | ScienceDirect Topics". sciencedirect.com. Retrieved 14 February 2021.
  13. 1 2 3 4 "Hepatitis A Vaccine: What you need to know" (PDF). Vaccine Information Statement. Centers for Disease Control and Prevention (CDC). 21 March 2006. Archived (PDF) from the original on 20 November 2007. Retrieved 12 March 2007.
  14. ↑ "Hepatitis, Viral, Type A". Travelers' Health: Yellow Book (CDC). Archived from the original on 28 March 2007. Retrieved 12 March 2007.
  15. 1 2 "Hepatitis A: Introduction". NHS Direct. 10 October 2006. Archived from the original on 10 March 2007. Retrieved 12 March 2007.
  16. ↑ Ott JJ, Irving G, Wiersma ST (December 2012). "Long-term protective effects of hepatitis A vaccines. A systematic review". Vaccine. 31 (1): 3–11. doi:10.1016/j.vaccine.2012.04.104. PMID 22609026.
  17. ↑ Irving GJ, Holden J, Yang R, Pope D (2012). "Hepatitis A immunisation in persons not previously exposed to hepatitis A". Cochrane Database Syst Rev. 7 (7): CD009051. doi:10.1002/14651858.CD009051.pub2. PMC 6823267. PMID 22786522.
  18. ↑ Patient Information Leaflet Archived 20 July 2011 at the Wayback Machine, sanofi pasteur, July 2010. Archived on the electronic Medicines Compendium of the UK. Accessed 30 November 2010.
  19. ↑ Epaxal Archived 19 January 2011 at the Wayback Machine, Crucell website. Accessed 30 November 2010.
  20. ↑ Full Prescribing Information Archived 18 August 2011 at the Wayback Machine, GlaxoSmithKline, July 2010. Archived on FDA website. Accessed 30 November 2010.
  21. ↑ "VAQTA (Hepatitis A Vaccine, Inactivated)" (PDF). U.S. Food and Drug Administration (FDA). p. 11. Archived (PDF) from the original on 21 February 2015. Retrieved 7 February 2014.
  22. ↑ "Twinrix". U.S. Food and Drug Administration (FDA). 3 October 2019. Retrieved 18 October 2020.
  23. ↑ "Australian Product Information – Vivaxim (Salmonella typhi Vi polysaccharide and hepatitis A virus antigen) Vaccine". Retrieved 18 October 2020.
  24. ↑ "Vivaxim Salmonella typhi vaccine; Hepatitis A vaccine". 6 March 2020. Retrieved 18 October 2020.
  25. ↑ "Vivaxim 1mL injection syringe composite pack". Therapeutic Goods Administration (TGA). Archived from the original on 19 October 2020. Retrieved 18 October 2020.
  26. ↑ "Summary for ARTG Entry: 82745 Vivaxim 1mL injection syringe composite pack". Therapeutic Goods Administration (TGA). Retrieved 18 October 2020.

Further reading

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