Hepatitis B vaccine - wikipedia Hepatitis B vaccine 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 ( what is this ? ) ( verify ) Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV / AIDS and those born premature. It is also recommended for health - care workers to be vaccinated. In healthy people routine immunization results in more than 95 % of people being protected. Blood testing to verify that the vaccine has worked is recommended in those at high risk. Additional doses may be needed in people with poor immune function but are not necessary for most people. 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. The vaccine is given by injection into a muscle. 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. It has not been linked to Guillain -- Barré syndrome. The current vaccines are produced with recombinant DNA techniques. They are available both by themselves and in combination with other vaccines. The first hepatitis B vaccine was approved in the United States in 1981. A recombinant version came to market in 1986. It is on the World Health Organization 's List of Essential Medicines, the most effective and safe medicines needed in a health system. As of 2014, the wholesale cost in the developing world is US $ 0.58 -- 13.20 per dose. In the United States it costs US $50 -- 100. Contents 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 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. The combination is superior for protecting these infants. The vaccine during pregnancy is not considered to be valuable in protecting babies of the infected mothers. Hepatitis B immunoglobulin before birth has not been well studied. In the United States vaccination is recommended for nearly all babies at birth. 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. 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. In many areas, vaccination against hepatitis B is also required for all health - care and laboratory staff. 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. The Centers for Disease Control and Prevention have issued recommendations for vaccination against hepatitis B among patients with diabetes mellitus. 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. Effectiveness 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. 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. 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 or to a high dose vaccine or to a double dose of a combined hepatitis A and B vaccine. Those who still fail to respond will require hepatitis B immunoglobulin ( HBIG ) if later exposed to the hepatitis B virus. Poor responses are mostly associated with being over the age of 40 years, obesity and smoking, and also in alcoholics, especially if with advanced liver disease. Patients who are immunosuppressed or on renal dialysis may respond less well and require larger or more frequent doses of vaccine. At least one study suggests that hepatitis B vaccination is less effective in patients with HIV. Duration of protection 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 coverage of between five and seven years, 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. 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, 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. Side effects 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. It has not been linked to Guillain -- Barré syndrome. Multiple sclerosis Several studies have looked for an association between recombinant hepatitis B vaccine ( HBV ) and multiple sclerosis ( MS ) in adults. Most studies do not support a causal relationship between hepatitis B vaccination and demyelinating diseases such as MS. A 2004 study reported a significant increase in risk within 3 years of vaccination. Some of these studies were criticized for methodological problems. 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. A 2007 study found that the vaccination does not seem to increase the risk of a first episode of MS in childhood. 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 in 2014. show Hepatitis 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 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. In 1968, this protein was found to be part of the virus that causes `` serum hepatitis '' ( hepatitis B) by virologist Alfred Prince. 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. 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. 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. 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. 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. 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. 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 does n't want to give credit to the other guy. '' Manufacture 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. 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. Brand names 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. Twinrix is a vaccine against hepatitis A and hepatitis B. Research This section does not cite any sources. Please help improve this section by adding citations to reliable sources. Unsourced material may be challenged and removed. ( August 2017 ) 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. 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Jump up ^ Mikaeloff, Y. ; Caridade, G. ; Rossier, M. ; Suissa, S. ; Tardieu, M. ( 2007 ). `` Hepatitis B Vaccination and the Risk of Childhood - Onset Multiple Sclerosis ''. Archives of Pediatrics & Adolescent Medicine. 161 ( 12 ) : 1176 -- 1182. doi : 10.1001 / archpedi. 161.12. 1176. PMID 18056563. Jump up ^ `` Hepatitis B ( HepB3 ) Data by country ''. WHO. Archived from the original on 24 June 2016. Retrieved 8 June 2016. Jump up ^ Blumberg B, Alter H ( 1965 ). `` A `` new '' antigen in leukemia sera ``. JAMA. 191 : 101 -- 106. doi : 10.1001 / jama. 1965.03080070025007. PMID 14239025. Jump up ^ Howard, Colin ; Zuckerman, Arie J. ( 1979 ). Hepatitis viruses of man. Boston : Academic Press. pp. 16 -- 18. ISBN 0 - 12 - 782150 - 3. ^ Jump up to : `` World Hepatitis Day : The History of the Hepatitis B Vaccine Planned Parenthood Advocates of Arizona ''. Blog.advocatesaz.org. 2012 - 07 - 26. Archived from the original on 2016 - 04 - 05. Retrieved 2017 - 04 - 27. Jump up ^ Fisher, Lawrence M. ( October 13, 1986 ). `` Biotechnology Spotlight Now Shines On Chiron ''. New York Times. Archived from the original on August 26, 2017. Jump up ^ Blumberg, Baruch ( 2002 ), Hepatitis B : The Hunt for a Killer Virus, Princeton : Princeton University Press. Jump up ^ Offit, Paul A. ( 2007 ). Vaccinated : One Man 's Quest to Defeat the World 's Deadliest Diseases. New York : Smithsonian Books / Collins, pp 135 -- 136. Jump up ^ `` Hepatitis B Vaccine from Merck ''. Archived from the original on 2010 - 04 - 21. Retrieved 2010 - 05 - 09. Jump up ^ `` CDC Viral Hepatitis ''. Atlanta, Georgia : Centers for Disease Control and Prevention. 2009 - 07 - 24. Archived from the original on 2009 - 10 - 20. Retrieved 2009 - 10 - 22. Jump up ^ https://www.reuters.com/article/us-dynavax-techs-fda/dynavaxs-hepatitis-b-vaccine-gets-fda-nod-on-third-try-shares-up-idUSKBN1D93AN External links Artificial induction of immunity / Immunization : Vaccines, Vaccination, Infection, Inoculation ( J07 ) Development Adjuvants List of vaccine ingredients Mathematical modelling Timeline Trials Classes Conjugate vaccine DNA vaccination Inactivated vaccine Live vector vaccine Attenuated vaccine Heterologous vaccine Subunit / component / Peptide / Virus - like particle Toxoid Administration Global : GAVI Alliance Policy Schedule Vaccine injury USA : ACIP Vaccine court Vaccines for Children Program VAERS VSD Vaccines Bacterial Anthrax Brucellosis Cholera Diphtheria Hib Leptospirosis Lyme disease Meningococcus MeNZB NmVac4 - A / C / Y / W - 135 Pertussis Plague Pneumococcal PCV PPSV Q fever Tetanus Tuberculosis BCG Typhoid Ty21a ViCPS Typhus combination : DTwP / DTaP Viral Adenovirus Flu H1N1 ( Pandemrix ) LAIV Hantavirus Hepatitis A Hepatitis B Hepatitis E HPV Cervarix Gardasil Japanese encephalitis Measles Mumps Mumpsvax Polio Sabin Salk Rabies Rotavirus Rubella Smallpox Dryvax Tick - borne encephalitis Varicella zoster chicken pox Zoster vaccine Yellow fever combination : MMR MMRV research : Chikungunya Cytomegalovirus Dengue Ebola Epstein -- Barr virus Hepatitis C HIV Protozoan Malaria RTS, S research : Trypanosomiasis Helminthiasis research : Hookworm Schistosomiasis Other Androvax ( androstenedione albumin ) Cancer vaccines ALVAC - CEA BCG Hepatitis B HPV Cervarix Gardasil PROSTVAC NicVAX Ovandrotone albumin ( Fecundin ) TA - CD TA - NIC combination DTaP - IPV / Hib DTaP - IPV - HepB Hexavalent vaccine Pentavalent vaccine Controversy General MMR NCVIA Pox party Thiomersal Andrew Wakefield Cedillo v. 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Question: when did the hepatitis b vaccine come out
Answer: 1981