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Hepatitis B vaccine
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Hepatitis B vaccine
Vaccine description
Target disease
Hepatitis B
Type
Subunit
Clinical data
Trade names
Recombivax HB
AHFS/Drugs.com
Monograph
MedlinePlus
a607014
ATC code
J07BC01 (WHO)
Identifiers
ChemSpider
none
Y (what is this?) (verify)
Hepatitis B vaccine is a vaccine that prevents hepatitis B.[1] The first dose is recommended within 24 hours of birth with either two or three more doses given after that.[1] This includes those with poor immune function such as from HIV/AIDS and those born premature.[1] It is also recommended for health-care workers to be vaccinated.[2] 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] 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 but not immunized, hepatitis B immune globulin should be given in addition to the vaccine.[1] The vaccine is given by injection into a muscle.[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 current 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.[3] A recombinant version came to market in 1986.[1] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[4] As of 2014, the wholesale cost in the developing world is US$0.58–13.20 per dose.[5] In the United States it costs US$50–100.[6]
Contents
[hide]
1 Medical uses
1.1 Effectiveness
1.2 Duration of protection
2 Side effects
2.1 Multiple sclerosis
3 Usage
4 History
5 Manufacture
6 Brand names
7 Research
8 References
9 External links
Medical uses[edit]
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 HBV.[7] The combination is superior for protecting these infants.[7] The vaccine during pregnancy is not considered to be valuable in protecting babies of the infected mothers.[8] Hepatitis B immunoglobulin before birth has not been well studied.[9]
In the United States vaccination is recommended for nearly all babies at birth.[10] 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 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.[11]
In the UK, the vaccine is offered to MSM, usually as part of a sexual health check-up. A similar situation is in operation in Ireland.[12]
In many areas, vaccination against hepatitis B is also required for all health-care and laboratory staff.[13] 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.[2]
The Centers for Disease Control and Prevention have issued recommendations for vaccination against hepatitis B among patients with diabetes mellitus.[14] The World Health Organization 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.[15]
Effectiveness[edit]
Following the primary course of 3 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.[16]
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.[16]
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 3 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[17] or to a high dose vaccine[18] or to a double dose of a combined hepatitis A and B vaccine.[19] Those who still fail to respond will require hepatitis B immunoglobulin (HBIG) if later exposed to the hepatitis B virus.[16]
Poor responses are mostly associated with being over the age of 40 years, obesity and smoking,[20] and also in alcoholics, especially if with advanced liver disease.[21] Patients who are immunosuppressed or on renal dialysis may respond less well and require larger or more frequent doses of vaccine.[16] At least one study suggests that hepatitis B vaccination is less effective in patients with HIV.[22]
Duration of protection[edit]
It is now believed that the hepatitis B vaccine provides indefinite protection. However, it was previously believed and suggested that the vaccination would only provide effective cover of between five and seven years,[23][24] 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.[25][26] 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,[27] and UK guidelines now suggest that for initial responders who require ongoing protection, such as for healthcare workers, only a single booster is advocated at 5 years.[16]
Side effects[edit]
Serious side effects from the hepatitis B vaccine are very uncommon. Pain may occur at the site of injection. It is safe for use during pregnancy or while breastfeeding.[citation needed] It has not been linked to Guillain–Barré syndrome.[1]
Multiple sclerosis[edit]
Several studies have looked for an association between recombinant hepatitis B vaccine (HBV) and multiple sclerosis (MS) in adults.[28] Most studies do not support a causal relationship between hepatitis B vaccination and demyelinating diseases such as MS.[29][28] A 2004 study reported a significant increase in risk within 3 years of vaccination. Some of these studies were criticized for methodological problems.[30] 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.[31] A 2007 study found that the vaccination does not seem to increase the risk of a first episode of MS in childhood.[32]
Usage[edit]
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 in 2014.[33]
showHepatitis B (HepB3) immunization coverage among 1-year-olds worldwide
Country
Coverage %
Afghanistan 75
Albania 98
Algeria 95
Andorra 96
Angola 80
Antigua and Barbuda 99
Argentina 94
Armenia 93
Australia 91
Austria 83
Azerbaijan 94
Bahamas 96
Bahrain 99
Bangladesh 95
Barbados 94
Belarus 97
Belgium 98
Belize 95
Benin 70
Bhutan 99
Bolivia (Plurinational State of) 94
Bosnia and Herzegovina 89
Botswana 95
Brazil 96
Brunei Darussalam 99
Bulgaria 95
Burkina Faso 91
Burundi 95
Côte d'Ivoire 67
Cabo Verde 95
Cambodia 97
Cameroon 87
Canada 75
Central African Republic 47
Chad 46
Chile 92
China 99
Colombia 90
Comoros 80
Congo 90
Cook Islands 99
Costa Rica 91
Croatia 95
Cuba 96
Cyprus 96
Czech Republic 99
Democratic People's Republic of Korea 93
Democratic Republic of the Congo 80
Djibouti 78
Dominica 97
Dominican Republic 89
Ecuador 83
Egypt 94
El Salvador 93
Equatorial Guinea 24
Eritrea 94
Estonia 93
Ethiopia 77
Fiji 99
France 82
Gabon 70
Gambia 96
Georgia 91
Germany 87
Ghana 98
Greece 96
Grenada 97
Guatemala 73
Guinea 51
Guinea-Bissau 80
Guyana 98
Haiti 48
Honduras 85
India 70
Indonesia 78
Iran (Islamic Republic of) 99
Iraq 62
Ireland 95
Israel 97
Italy 94
Jamaica 92
Jordan 98
Kazakhstan 95
Kenya 81
Kiribati 75
Kuwait 96
Kyrgyzstan 96
Lao People's Democratic Republic 88
Latvia 92
Lebanon 81
Lesotho 96
Liberia 50
Libya 94
Lithuania 94
Luxembourg 94
Madagascar 73
Malawi 91
Malaysia 96
Maldives 99
Mali 77
Malta 90
Marshall Islands 79
Mauritania 84
Mauritius 97
Mexico 84
Micronesia (Federated States of) 83
Monaco 99
Mongolia 99
Montenegro 87
Morocco 99
Mozambique 78
Myanmar 75
Namibia 88
Nauru 95
Nepal 92
Netherlands 95
New Zealand 93
Nicaragua 98
Niger 68
Nigeria 66
Niue 99
Oman 98
Pakistan 73
Palau 99
Panama 80
Papua New Guinea 62
Paraguay 87
Peru 88
Philippines 79
Poland 96
Portugal 98
Qatar 99
Republic of Korea 99
Republic of Moldova 92
Romania 94
Russian Federation 97
Rwanda 99
Saint Kitts and Nevis 98
Saint Lucia 99
Saint Vincent and the Grenadines 98
Samoa 91
San Marino 80
São Tomé and Príncipe 95
Saudi Arabia 98
Senegal 89
Serbia 92
Seychelles 99
Sierra Leone 83
Singapore 97
Slovakia 97
Solomon Islands 88
Somalia 42
South Africa 74
Spain 96
Sri Lanka 99
Sudan 94
Suriname 85
Swaziland 98
Sweden 42
Syrian Arab Republic 71
Tajikistan 97
Thailand 99
The former Yugoslav republic of Macedonia 97
Timor-Leste 77
Togo 87
Tonga 82
Trinidad and Tobago 92
Tunisia 98
Turkey 96
Turkmenistan 97
Tuvalu 90
Uganda 78
Ukraine 46
United Arab Emirates 94
United Republic of Tanzania 97
United States of America 90
Uruguay 95
Uzbekistan 99
Vanuatu 64
Venezuela (Bolivarian Republic of) 78
Viet Nam 95
Yemen 88
Zambia 86
Zimbabwe 91
History[edit]
The road to the hepatitis B vaccine began in 1963 when American physician/geneticist Baruch Blumberg discovered what he called the "Australia Antigen" (now called HBsAg) in the serum of an Australian Aboriginal person.[34] In 1968, this protein was found to be part of the virus that causes "serum hepatitis" (hepatitis B) by virologist Alfred Prince.[35] 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.[36]
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.[36]
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.[36] 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.[37] 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.[36] This is the vaccine still in use today.
In 1976, Blumberg had 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.[38] 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."[39]
Manufacture[edit]
The vaccine contains one of the viral envelope proteins, hepatitis B surface antigen (HBsAg). It is now produced by yeast cells, into which the genetic code for HBsAg has been inserted.[40] 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.[41]
Brand names[edit]
The common brands available are Recombivax HB (Merck), Engerix-B (GSK), Elovac B (Human Biologicals Institute, a division of Indian Immunologicals Limited), Genevac B (Serum Institute), Shanvac B, etc. These vaccines are given by the intramuscular route. In late 2017 the FDA approved a new vaccine called Heplisav-B from Dynavax Technologies Corps. This two-dose vaccine will compete with Engerix-B's three-dose vaccine.[42]
Twinrix is a vaccine against hepatitis A and hepatitis B.
Research[edit]
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Injectable Hepatitis B vaccines require expensive production processes and refrigeration, which can make them difficult to access in developing countries. As a result, researchers have been working to engineer plants capable of producing the ingredients necessary to make vaccines so that people can eat these plants to receive the vaccine. Potatoes, bananas, lettuce, carrots, tobacco are some of the plants being genetically engineered to produce the Hepatitis B vaccine ingredients.
The process of genetically engineering plants to produce the vaccine includes extracting the gene that codes for Hepatitis B surface antigens from the Hepatitis B genome, and placing it in a bacterial plasmid. The bacteria then infect a plant, which will produce the surface antigens. When a human eats the plant, their body is stimulated to produce an antibody response to the surface antigens. Although concerns remain in improving the efficacy of edible vaccines, controlling the dosage of vaccine in each plant, and managing land allocation for this process, scientists consider this a promising avenue for vaccinating underprivileged areas of the world.
References[edit]
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Retrieved from "https://en.wikipedia.org/w/index.php?title=Hepatitis_B_vaccine&oldid=845431247"
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