Hepatitis B vaccine

Hepatitis B vaccine
Hepatitis B pre-filled syringe
Vaccine description
Target diseaseHepatitis B virus
TypeSubunit
Names
Trade namesRecombivax HB, Engerix-B, Heplisav-B, others
Clinical data
Main usesPrevent hepatitis B[1]
Side effectsPain at the site of injection[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
  • AU: B2[2]
  • US: C (Risk not ruled out)[2]
    Routes of
    use    		Intramuscular (IM)
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa607014
    Legal
    License data
    Legal status

    Hepatitis B vaccine is a vaccine that prevents hepatitis B.[1] It is given by injection, usually into muscle, but can be given under the skin in people with bleeding disorders.[6] In healthy people routine immunization results in more than 95% of people being protected.[1] Blood testing to verify that the vaccine has worked is recommended in those at high risk.[1]

    The first dose is recommended within 24 hours of birth with either two or three more doses given after that.[1] This includes in those with poor immune function such as from HIV/AIDS and those born premature.[1] It is also recommended that health-care workers be vaccinated.[7] Additional doses may be needed in people with poor immune function but are not necessary for most people.[1] In those who have been exposed to the hepatitis B virus (HBV) but not immunized, hepatitis B immune globulin should be given in addition to the vaccine.[1]

    Serious side effects from the hepatitis B vaccine are very uncommon.[1] Pain may occur at the site of injection.[1] It is safe for use during pregnancy or while breastfeeding.[1] It has not been linked to Guillain–Barré syndrome.[1] The hepatitis B vaccines are produced with recombinant DNA techniques.[1] They are available both by themselves and in combination with other vaccines.[1]

    The first hepatitis B vaccine was approved in the United States in 1981.[8] It has been available since 1982.[9] A recombinant version came to market in 1986.[1] It is on the World Health Organization's List of Essential Medicines.[10] As of 2014, the wholesale cost in the developing world is US$0.58–13.20 per dose.[11] In the United States it costs US$50–100.[12]

    Medical uses

    Hepatitis B vaccination, hepatitis B immunoglobulin, and the combination of hepatitis B vaccine plus hepatitis B immunoglobulin, all are considered as preventive for babies born to mothers infected with hepatitis B virus (HBV).[13] The combination is superior for protecting these infants.[13] The vaccine during pregnancy is not considered to be valuable in protecting babies of the infected mothers.[14] Hepatitis B immunoglobulin before birth has not been well studied.[15]

    In the United States vaccination is recommended for nearly all babies at birth.[16] Many countries now routinely vaccinate infants against hepatitis B. In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to a marked reduction in liver cancer. This was reported in Taiwan where the implementation of a nationwide hepatitis B vaccination program in 1984 was associated with a decline in the incidence of childhood hepatocellular carcinoma.[17]

    In the UK, the vaccine is offered to men who have sex with men (MSM), usually as part of a sexual health check-up. A similar situation is in operation in Ireland.[18]

    In many areas, vaccination against hepatitis B is also required for all health-care and laboratory staff.[19] Both types of the vaccine, the plasma-derived vaccine (PDV) and recombinant vaccine (RV), seems to be able to elicit similar protective anti-HBs levels.[7]

    The Centers for Disease Control and Prevention (CDC) issued recommendations for vaccination against hepatitis B among patients with diabetes mellitus.[20] The World Health Organization (WHO) recommends a pentavalent vaccine, combining vaccines against diphtheria, tetanus, pertussis and Haemophilus influenzae type B with the vaccine against hepatitis B. There is not yet sufficient evidence on how effective this pentavalent vaccine is in relation to the individual vaccines.[21] A pentavalent vaccine combining vaccines against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis is approved in the U.S. and is recommended by the Advisory Committee on Immunization Practices (ACIP).[22][23][24]

    Effectiveness

    Following the primary course of three vaccinations, a blood test may be taken after an interval of 1–4 months to establish if there has been an adequate response, which is defined as an anti-hepatitis B surface antigen (anti-Hbs) antibody level above 100 mIU/ml. Such a full response occurs in about 85–90% of individuals.[25]

    An antibody level between 10 and 100 mIU/ml is considered a poor response, and these people should receive a single booster vaccination at this time, but do not need further retesting.[25]

    People who fail to respond (anti-Hbs antibody level below 10 mIU/ml) should be tested to exclude current or past Hepatitis B infection, and given a repeat course of three vaccinations, followed by further retesting 1–4 months after the second course. Those who still do not respond to a second course of vaccination may respond to intradermal administration[26] or to a high dose vaccine[27] or to a double dose of a combined hepatitis A and B vaccine.[28] Those who still fail to respond will require hepatitis B immunoglobulin (HBIG) if later exposed to the hepatitis B virus.[25]

    Poor responses are mostly associated with being over the age of 40 years, obesity, celiac disease, and tobacco smoking,[26][29] and also in alcoholics, especially if with advanced liver disease.[30] People who are immunosuppressed or on dialysis may not respond as well and require larger or more frequent doses of vaccine.[25] At least one study suggests that hepatitis B vaccination is less effective in patients with HIV.[31]

    Duration

    It is believed that the hepatitis B vaccine provides indefinite protection. However, it was previously believed and suggested that the vaccination would only provide effective coverage of between five and seven years,[32][33] but subsequently it has been appreciated that long-term immunity derives from immunological memory which outlasts the loss of antibody levels and hence subsequent testing and administration of booster doses is not required in successfully vaccinated immunocompetent individuals.[34][35] Hence with the passage of time and longer experience, protection has been shown for at least 25 years in those who showed an adequate initial response to the primary course of vaccinations,[36] and UK guidelines now suggest that people who respond to the vaccine and are at risk of occupational exposure, such as for healthcare workers, a single booster is recommended five years after initial immunization.[25]

    Dosage

    The defined daily dose is not established[37]

    Side effects

    Serious side effects from the hepatitis B vaccine are very rare.[1] Pain may occur at the site of injection.[1] It is generally considered safe for use, during pregnancy or while breastfeeding.[1][38] It has not been linked to Guillain–Barré syndrome.[1]

    Multiple sclerosis

    Several studies have looked for an association between recombinant hepatitis B vaccine and multiple sclerosis (MS) in adults.[39] Most studies do not support a causal relationship between hepatitis B vaccination and demyelinating diseases such as MS.[39][40][41] A 2004 study reported a significant increase in risk within three years of vaccination. Some of these studies were criticized for methodological problems.[42] This controversy created public misgivings about HB vaccination, and hepatitis B vaccination in children remained low in several countries. A 2006 study concluded that evidence did not support an association between HB vaccination and sudden infant death syndrome, chronic fatigue syndrome, or multiple sclerosis.[43] A 2007 study found that the vaccination does not seem to increase the risk of a first episode of MS in childhood.[44] Hepatitis B vaccination has not been linked to onset of autoimmune diseases in adulthood.[45]

    Usage

    The following is a list of countries by the percentage of infants receiving three doses of hepatitis B vaccine as published by the World Health Organization (WHO) in 2017.[46]

    Hepatitis B (HepB3) immunization coverage
    among one-year-olds worldwide
    Country Coverage %
    Afghanistan65
    Albania99
    Algeria91
    Andorra98
    Angola52
    Antigua and Barbuda95
    Argentina86
    Armenia94
    Australia95
    Austria90
    Azerbaijan95
    Bahamas94
    Bahrain98
    Bangladesh97
    Barbados90
    Belarus98
    Belgium97
    Belize88
    Benin82
    Bhutan98
    Bolivia (Plurinational State of)83
    Bosnia and Herzegovina77
    Botswana95
    Brazil93
    Brunei Darussalam99
    Bulgaria92
    Burkina Faso91
    Burundi91
    Côte d'Ivoire84
    Cabo Verde86
    Cambodia93
    Cameroon86
    Canada69
    Central African Republic47
    Chad41
    Chile93
    China99
    Colombia92
    Comoros91
    Congo69
    Cook Islands99
    Costa Rica97
    Croatia94
    Cuba99
    Cyprus97
    Czech Republic94
    Democratic People's Republic of Korea97
    Democratic Republic of the Congo81
    Djibouti68
    Dominica91
    Dominican Republic81
    Ecuador84
    Egypt94
    El Salvador85
    Equatorial Guinea25
    Eritrea95
    Estonia92
    Eswatini90
    Ethiopia73
    Fiji99
    France90
    Gabon75
    Gambia92
    Georgia91
    Germany87
    Ghana99
    Greece96
    Grenada96
    Guatemala82
    Guinea45
    Guinea-Bissau87
    Guyana97
    Haiti58
    Honduras97
    India88
    Indonesia79
    Iran (Islamic Republic of)99
    Iraq63
    Ireland95
    Israel97
    Italy94
    Jamaica93
    Jordan99
    Kazakhstan99
    Kenya82
    Kiribati90
    Kuwait99
    Kyrgyzstan92
    Lao People's Democratic Republic85
    Latvia98
    Lebanon78
    Lesotho93
    Liberia86
    Libya94
    Lithuania94
    Luxembourg94
    Madagascar74
    Malawi88
    Malaysia98
    Maldives99
    Mali66
    Malta88
    Marshall Islands82
    Mauritania81
    Mauritius96
    Mexico93
    Micronesia (Federated States of)80
    Monaco99
    Mongolia99
    Montenegro73
    Morocco99
    Mozambique80
    Myanmar89
    Namibia88
    Nauru87
    Nepal90
    Netherlands92
    New Zealand94
    Nicaragua98
    Niger81
    Nigeria42
    Niue99
    Oman99
    Pakistan75
    Palau98
    Panama81
    Papua New Guinea56
    Paraguay91
    Peru83
    Philippines88
    Poland95
    Portugal98
    Qatar97
    Republic of Korea98
    Republic of Moldova89
    Romania92
    Russian Federation97
    Rwanda98
    Saint Kitts and Nevis98
    Saint Lucia80
    Saint Vincent and the Grenadines99
    Samoa73
    San Marino86
    São Tomé and Príncipe95
    Saudi Arabia98
    Senegal91
    Serbia93
    Seychelles98
    Sierra Leone90
    Singapore96
    Slovakia96
    Solomon Islands99
    Somalia42
    South Africa66
    Spain93
    Sri Lanka99
    Sudan95
    Suriname81
    Swaziland98
    Sweden76
    Syrian Arab Republic52
    Tajikistan96
    Thailand99
    The former Yugoslav republic of Macedonia91
    Timor-Leste76
    Togo90
    Tonga81
    Trinidad and Tobago89
    Tunisia98
    Turkey96
    Turkmenistan99
    Tuvalu96
    Uganda85
    Ukraine52
    United Arab Emirates98
    United Republic of Tanzania97
    United States of America93
    Uruguay95
    Uzbekistan99
    Vanuatu85
    Venezuela (Bolivarian Republic of)84
    Viet Nam94
    Yemen68
    Zambia94
    Zimbabwe89

    History

    In 1963, the American physician/geneticist Baruch Blumberg discovered what he called the "Australia Antigen" (now called HBsAg) in the serum of an Australian Aboriginal person.[47] In 1968, this protein was found to be part of the virus that causes "serum hepatitis" (hepatitis B) by virologist Alfred Prince.[48] The American microbiologist/vaccinologist Maurice Hilleman at Merck used three treatments (pepsin, urea and formaldehyde) of blood serum together with rigorous filtration to yield a product that could be used as a safe vaccine. Hilleman hypothesized that he could make an HBV vaccine by injecting patients with hepatitis B surface protein. In theory, this would be very safe, as these excess surface proteins lacked infectious viral DNA. The immune system, recognizing the surface proteins as foreign, would manufacture specially shaped antibodies, custom-made to bind to, and destroy, these proteins. Then, in the future, if the patient were infected with HBV, the immune system could promptly deploy protective antibodies, destroying the viruses before they could do any harm.[49]

    Hilleman collected blood from gay men and intravenous drug users—groups known to be at risk for viral hepatitis. This was in the late 1970s, when HIV was yet unknown to medicine. In addition to the sought-after hepatitis B surface proteins, the blood samples likely contained HIV. Hilleman devised a multistep process to purify this blood so that only the hepatitis B surface proteins remained. Every known virus was killed by this process, and Hilleman was confident that the vaccine was safe.[49]

    The first large-scale trials for the blood-derived vaccine were performed on gay men, in accordance with their high-risk status. Later, Hilleman's vaccine was falsely blamed for igniting the AIDS epidemic. (See Wolf Szmuness) But, although the purified blood vaccine seemed questionable, it was determined to have indeed been free of HIV. The purification process had destroyed all viruses—including HIV.[49] The vaccine was approved in 1981.

    The blood-derived hepatitis B vaccine was withdrawn from the marketplace in 1986, when Pablo DT Valenzuela, Research Director of Chiron Corporation, succeeded in making the antigen in yeast and invented the world's first recombinant vaccine.[50] The recombinant vaccine was developed by inserting the HBV gene that codes for the surface protein into the yeast Saccharomyces cerevisiae. This allows the yeast to produce only the noninfectious surface protein, without any danger of introducing actual viral DNA into the final product.[49] This is the vaccine still in use today.

    In 1976, Blumberg won the Nobel Prize in Physiology or Medicine for his work on hepatitis B (sharing it with Daniel Carleton Gajdusek for his work on kuru). In 2002, Blumberg published a book, Hepatitis B: The Hunt for a Killer Virus.[51] In the book, according to Paul A. Offit—Hilleman's biographer and an accomplished vaccinologist himself—Blumberg...

    ... claimed that the hepatitis B vaccine was his invention. Maurice Hilleman's name is mentioned once.... Blumberg failed to mention that it was Hilleman who had figured out how to inactivate hepatitis B virus, how to kill all other possible contaminating viruses, how to completely remove every other protein found in human blood, and how to do all of this while retaining the structural integrity of the surface protein. Blumberg had identified Australia antigen, an important first step. But all of the other steps—the ones critical to making a vaccine—belonged to Hilleman. Later, Hilleman recalled, "I think that [Blumberg] deserves a lot of credit, but he doesn't want to give credit to the other guy."[52]

    Robert Purcell, a virologist, has emphasized the importance of the hepatitis B vaccine; in figuring out the hepatitis viruses, generally.[53][54]

    In 2017, a two-dose HBV vaccine for adults, Heplisav-B gained U.S. Food and Drug Administration (FDA) approval.[55] It uses recombinant HB surface antigen, similar to previous vaccines, but includes a novel CpG 1018 adjuvant, a 22-mer phosphorothioate-linked oligodeoxynucleotide. It was non-inferior with respect to immunogenicity.[56]

    Manufacture

    The vaccine contains one of the viral envelope proteins, hepatitis B surface antigen (HBsAg). It is produced by yeast cells, into which the gene for HBsAg has been inserted.[57] Afterward an immune system antibody to HBsAg is established in the bloodstream. The antibody is known as anti-HBs. This antibody and immune system memory then provide immunity to HBV infection.[58]

    Brand names

    The common brands available are Recombivax HB (Merck),[59] Engerix-B (GSK),[60] Elovac B (Human Biologicals Institute, a division of Indian Immunologicals Limited), Genevac B (Serum Institute), Shanvac B, Heplisav-B,[55] etc. These vaccines are given by the intramuscular route.

    Twinrix (GSK) is a vaccine against hepatitis A and hepatitis B.[61][62]

    Pediarix is a vaccine against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis.[63]

    Vaxelis is a vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B (Meningococcal Protein Conjugate), and hepatitis B.[64][65]

    References

    1. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 World Health Organization (July 2017). "Hepatitis B vaccines: WHO position paper – July 2017". Wkly. Epidemiol. Rec. 92 (27): 369–92. hdl:10665/255873. PMID 28685564.
    2. 1 2 "Hepatitis b adult vaccine Use During Pregnancy". Drugs.com. 27 April 2020. Archived from the original on 27 October 2020. Retrieved 7 May 2020.
    3. ↑ "Engerix B SmPC". Datapharm. 24 April 2017. Archived from the original on 22 September 2019. Retrieved 22 September 2019.
    4. ↑ "HBVaxPro SmPC". Datapharm. 12 March 2019. Archived from the original on 22 September 2019. Retrieved 22 September 2019.
    5. ↑ "Hepatitis B Vaccine Monograph for Professionals". Drugs.com. 1 September 2019. Archived from the original on 21 October 2019. Retrieved 19 December 2019.
    6. ↑ Lampiris, Harry W.; maddix, Daniel S. (2020). "Appendix: Vaccines, immune globulins, and other complex biologic products". In Katzung, Bertram G.; Trevor, Anthony J. (eds.). Basic and Clinical Pharmacology (15th ed.). New York: McGraw-Hill. p. 1228. ISBN 978-1-260-45231-0. Archived from the original on 10 October 2021. Retrieved 27 December 2021.
    7. 1 2 Chen W, Gluud C (October 2005). "Vaccines for preventing hepatitis B in health-care workers". The Cochrane Database of Systematic Reviews (4): CD000100. doi:10.1002/14651858.CD000100.pub3. PMID 16235273.
    8. ↑ Moticka, Edward (25 November 2015). A Historical Perspective on Evidence-Based Immunology. p. 336. ISBN 9780123983756.
    9. ↑ Van Damme, Pierre; Ward, John W.; Shovel, Daniel; Zanetti, Alessandro (2018). "25. Hepatitis B vaccines". In Plotkin, Stanley A.; Orenstein, Walter; Offit, Paul A.; Edwards, Kathryn M. (eds.). Vaccines (Seventh ed.). Philadelphia: Elsevier. p. 342-362. ISBN 978-0-323-35761-6. Archived from the original on 11 January 2022. Retrieved 3 January 2022.
    10. ↑ 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.
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    12. ↑ Hamilton, Richart (2015). Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. Jones & Bartlett Learning. p. 314. ISBN 9781284057560.
    13. 1 2 Lee C, Gong Y, Brok J, Boxall EH, Gluud C (April 2006). "Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers". The Cochrane Database of Systematic Reviews (2): CD004790. doi:10.1002/14651858.CD004790.pub2. PMID 16625613.
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    15. ↑ Eke AC, Eleje GU, Eke UA, Xia Y, Liu J (February 2017). "Hepatitis B immunoglobulin during pregnancy for prevention of mother-to-child transmission of hepatitis B virus". The Cochrane Database of Systematic Reviews. 2: CD008545. doi:10.1002/14651858.CD008545.pub2. PMC 6464495. PMID 28188612.
    16. ↑ Committee On Infectious Diseases; Committee On Fetus And Newborn (September 2017). "Elimination of Perinatal Hepatitis B: Providing the First Vaccine Dose Within 24 Hours of Birth". Pediatrics. 140 (3): e20171870. doi:10.1542/peds.2017-1870. PMID 28847980.{{cite journal}}: CS1 maint: multiple names: authors list (link)
    17. ↑ Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, Liang DC, Shau WY, Chen DS (June 1997). "Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group". The New England Journal of Medicine. 336 (26): 1855–9. doi:10.1056/NEJM199706263362602. PMID 9197213.
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    20. ↑ Centers for Disease Control Prevention (CDC) (December 2011). "Use of hepatitis B vaccination for adults with diabetes mellitus: recommendations of the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR Morb. Mortal. Wkly. Rep. 60 (50): 1709–11. PMID 22189894. Archived (PDF) from the original on 17 October 2020. Retrieved 7 May 2020.
    21. ↑ Bar-On ES, Goldberg E, Hellmann S, Leibovici L (April 2012). "Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB)". The Cochrane Database of Systematic Reviews. 4 (4): CD005530. doi:10.1002/14651858.CD005530.pub3. PMID 22513932.
    22. ↑ Centers for Disease Control Prevention (CDC) (March 2003). "FDA licensure of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant), and poliovirus vaccine combined, (PEDIARIX) for use in infants". MMWR Morb. Mortal. Wkly. Rep. 52 (10): 203–4. PMID 12653460.
    23. ↑ Centers for Disease Control Prevention (CDC) (October 2008). "Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine and guidance for use as a booster dose" (PDF). MMWR Morb. Mortal. Wkly. Rep. 57 (39): 1078–9. PMID 18830212. Archived (PDF) from the original on 7 May 2020. Retrieved 7 May 2020.
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    25. 1 2 3 4 5 Joint Committee on Vaccination and Immunisation (2006). "Chapter 18: Hepatitis B". Immunisation Against Infectious Disease 2006 ("The Green Book") (3rd edition (Chapter 18 revised 10 October 2007) ed.). Edinburgh: Stationery Office. p. 468. ISBN 978-0-11-322528-6. Archived from the original (PDF) on 7 January 2013.
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    28. ↑ Cardell K, Akerlind B, Sällberg M, Frydén A (August 2008). "Excellent response rate to a double dose of the combined hepatitis A and B vaccine in previous nonresponders to hepatitis B vaccine". The Journal of Infectious Diseases. 198 (3): 299–304. doi:10.1086/589722. PMID 18544037.
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    32. ↑ Krugman S, Davidson M (1987). "Hepatitis B vaccine: prospects for duration of immunity". The Yale Journal of Biology and Medicine. 60 (4): 333–9. PMC 2590237. PMID 3660859.
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    35. ↑ "Are booster immunisations needed for lifelong hepatitis B immunity? European Consensus Group on Hepatitis B Immunity". Lancet. 355 (9203): 561–5. February 2000. doi:10.1016/S0140-6736(99)07239-6. PMID 10683019.
    36. ↑ Van Damme P, Van Herck K (March 2007). "A review of the long-term protection after hepatitis A and B vaccination". Travel Medicine and Infectious Disease. 5 (2): 79–84. doi:10.1016/j.tmaid.2006.04.004. PMID 17298912.
    37. ↑ "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 1 July 2021. Retrieved 22 September 2020.
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    39. 1 2 Martínez-Sernández V, Figueiras A (August 2013). "Central nervous system demyelinating diseases and recombinant hepatitis B vaccination: a critical systematic review of scientific production". Journal of Neurology. 260 (8): 1951–9. doi:10.1007/s00415-012-6716-y. PMID 23086181.
    40. ↑ "FAQs about Hepatitis B Vaccine (Hep B) and Multiple Sclerosis". Centers for Disease Control and Prevention (CDC). 9 October 2009. Archived from the original on 10 November 2009.
    41. ↑ Mouchet J, Salvo F, Raschi E, Poluzzi E, Antonazzo IC, De Ponti F, Bégaud B (March 2018). "Hepatitis B vaccination and the putative risk of central demyelinating diseases - A systematic review and meta-analysis". Vaccine. 36 (12): 1548–55. doi:10.1016/j.vaccine.2018.02.036. PMID 29454521.
    42. ↑ Hernán MA, Jick SS, Olek MJ, Jick H (September 2004). "Recombinant hepatitis B vaccine and the risk of multiple sclerosis: a prospective study". Neurology. 63 (5): 838–42. doi:10.1212/01.WNL.0000138433.61870.82. PMID 15365133.
    43. ↑ Zuckerman JN (February 2006). "Protective efficacy, immunotherapeutic potential, and safety of hepatitis B vaccines". Journal of Medical Virology. 78 (2): 169–77. doi:10.1002/jmv.20524. PMID 16372285.
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