Hepatitis A vaccine

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Hepatitis A vaccine
Vaccine description
Target diseaseHepatitis A
TypeAttenuated, inactivated
Clinical data
Trade namesBiovac A, Havrix, others
AHFS/Drugs.comConsumer Drug Information
  • Safety undetermined, risk likely low
Routes of
ATC code
Legal status
Legal status
  • none
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Hepatitis A vaccine is a vaccine that prevents hepatitis A.[1] It is effective in around 95% of cases and lasts for at least fifteen years and possibly a person's entire life.[1][2] If given, two doses are recommended beginning after the age of one.[1] It is given by injection into a muscle.[1]

The World Health Organization (WHO) recommends universal vaccination in areas where the diseases is moderately common.[1] Where the disease is very common, widespread vaccination is not recommended as all people typically develop immunity through infection when a child.[1] The Centers for Disease Control and Prevention (CDC) recommends vaccinating adults who are at high risk and all children.[3]

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]

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, the most effective and safe medicines needed in a health system.[5] In the United States it costs US$50–100.[6]

Medical uses[edit]

Within the US, the vaccine was phased in around 1996 for children living in high-risk areas. In 1999, it was spread to areas with elevating levels of infection. In the US 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 FDA license for Havrix by GlaxoSmithKline is dated in 1995,[7] it has been in use in Europe since 1993.

The US Centers for Disease Control and Prevention, 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 within close proximity to the virus, and people who are living in communities where an outbreak is present.[8] Hepatitis A is the most common vaccine-preventable virus acquired during travel,[9] so people travelling to places where the virus is common like the Indian subcontinent, Africa, Central America, South America, the far East, and Eastern Europe should be vaccinated.[8][10]

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.[8] Protection against hepatitis A begins approximately two to four weeks after the initial vaccination.[8][10] Protection lasts at least 15 years and is estimated to last at least 25 years if the booster is administered.[2]

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.[11]

Commercial vaccines[edit]

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).[12]
  • 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.[13]
  • 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.[14]
  • 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.[15]
  • 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[edit]


  1. ^ a b c d e f g h i j k "WHO position paper on hepatitis A vaccines – June 2012" (PDF). Wkly Epidemiol Rec. 87 (28/29): 261–76. 13 July 2012. PMID 22905367. Archived (PDF) from the original on 16 December 2015.
  2. ^ a b 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.
  3. ^ "Hepatitis A In-Short". CDC. 25 July 2014. Archived from the original on 10 December 2015. Retrieved 7 December 2015.
  4. ^ Patravale, Vandana; Dandekar, Prajakta; Jain, Ratnesh (2012). Nanoparticulate drug delivery perspectives on the transition from laboratory to market (1. publ. ed.). Oxford: Woodhead Pub. p. 212. ISBN 9781908818195.
  5. ^ "WHO Model List of Essential Medicines (19th List)" (PDF). World Health Organization. April 2015. Archived (PDF) from the original on 13 December 2016. Retrieved 8 December 2016.
  6. ^ Hamilton, Richart (2015). Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. Jones & Bartlett Learning. p. 314. ISBN 9781284057560.
  7. ^ "Hepatitis A Vaccine Information". Vaccine Information. ImmunizationInfo. Archived from the original on 30 June 2007. Retrieved 19 June 2008.
  8. ^ a b c d "Hepatitis A Vaccine: What you need to know" (PDF). Vaccine Information Statement. CDC. 21 March 2006. Archived (PDF) from the original on 20 November 2007. Retrieved 12 March 2007.
  9. ^ "Hepatitis, Viral, Type A". Travelers' Health: Yellow Book (CDC). Archived from the original on 28 March 2007. Retrieved 12 March 2007.
  10. ^ a b "Hepatitis A: Introduction". NHS Direct. 10 October 2006. Archived from the original on 10 March 2007. Retrieved 12 March 2007.
  11. ^ 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: CD009051. doi:10.1002/14651858.CD009051.pub2. PMID 22786522.
  12. ^ 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.
  13. ^ Epaxal Archived 19 January 2011 at the Wayback Machine, Crucell website. Accessed 30 November 2010.
  14. ^ Full Prescribing Information Archived 18 August 2011 at the Wayback Machine, GlaxoSmithKline, July 2010. Archived on FDA website. Accessed 30 November 2010.
  15. ^ "VAQTA® (Hepatitis A Vaccine, Inactivated)" (PDF). FDA.gov: Merck & CO., INC. p. 11. Archived (PDF) from the original on 21 February 2015. Retrieved 7 February 2014.
  16. ^ "Archived copy" (PDF). Archived (PDF) from the original on 4 March 2016. Retrieved 1 October 2015.CS1 maint: Archived copy as title (link)
  17. ^ "Archived copy". Archived from the original on 1 October 2015. Retrieved 10 April 2017.CS1 maint: Archived copy as title (link)