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. The vaccine is also recommended to premature infants and people with poor immune function such as from HIV/AIDS. It is also recommended that health-care workers 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. Hepatitis B vaccines are produced with recombinant DNA techniques and contain immunologic adjuvant. They are available both by themselves and in combination with other vaccines.
The first hepatitis B vaccine (Merck's Heptavax-B) was approved in the United States in 1981. A recombinant version (Merck's Recombivax-HB) came to market in 1986. It is on the World Health Organization's List of Essential Medicines. Both versions were developed by Maurice Hilleman and his team.
Medical uses In the United States vaccination is recommended for nearly all babies at birth. Many countries 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.
In the United Kingdom, the vaccine is given to all babies at birth and is also offered to people in various categories at higher risk, including men who have sex with men.
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 and the recombinant vaccine, seem to be able to elicit similar protective anti-HBs levels.
The US Centers for Disease Control and Prevention (CDC) issued recommendations for vaccination against hepatitis B among people with diabetes. 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 sufficient evidence on how effective this pentavalent vaccine is compared to the individual vaccines. A pentavalent vaccine combining vaccines against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis is approved in the US and is recommended by the Advisory Committee on Immunization Practices.
Hepatitis B vaccination, hepatitis B immunoglobulin, and the combination of hepatitis B vaccine plus hepatitis B immunoglobulin, are all considered as preventive for babies born to mothers infected with hepatitis B virus. The combination is superior for protecting these infants. The effectiveness of being vaccinated during pregnancy to prevent vertical transmission of hepatitis B to infants has not been studied. Hepatitis B immunoglobulin before birth has not been well studied.
Effectiveness Studies have found that that immune memory against HepB is sustained for at least 30 years after vaccination, and protects against clinical disease and chronic HepB infection, even in cases where anti-hepatitis B surface antigen (anti-Hbs) levels decline below detectable levels. Testing to confirm successful immunization or sustained immunity is not necessary or recommended for most people, but is recommended for infants born to a mother who tests positive for HBsAg or whose HBsAg status is not known; for healthcare and public safety workers; for immunocompromised people such as haemodialysis patients, HIV patients, haematopoietic stem cell transplant [HSCT] recipients, or people receiving chemotherapy; and for sexual partners of HBsAg-positive people.
An anti-Hbs antibody level above 100mIU/ml is deemed adequate and occurs in about 85–90% of individuals. An antibody level between 10 and 100mIU/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 10mIU/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 injection 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, celiac disease, and tobacco smoking, and also in alcoholics, especially if with advanced liver disease. People who are immunosuppressed or on dialysis may not respond as 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. Cold or Flu-like symptoms can develop after receiving the vaccine, but these are short-lived. As with any injection, the muscle can become tender around the injection point for some time afterward The immune response to the hepatitis B vaccine can be impaired by the presence of parasitic infections such as helminthiasis.
The HepB vaccine is vital for use for infants who contract HepB. 90% of infants who contract HepB and do not receive the vaccination will develop chronic infection. These chronic hepatitis B virus infections are life-threatening, with a 15–25% risk of death from complications.
Duration of protection The hepatitis B vaccine is believed to provide indefinite protection. Older literature assumed that immunity would wane with antibody titers and only effectively last five to seven years, but immune-challenge studies show that even after 30 years, the immune system maintains the ability to produce an anamnestic response, i.e. to rapidly bump up antibody levels when the previously seen antigen is detected. This shows that the immunological memory is not affected by the loss of antibody levels. As a result, subsequent antibody testing and administration of booster doses is not required in successfully vaccinated immunocompetent individuals. UK guidelines 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.
Side effects Serious side effects from the hepatitis B vaccine are very rare. Pain may occur at the site of injection. It is generally considered 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 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 three years of vaccination. Some of these studies were criticized for methodological problems. This controversy created public misgivings about hepatitis B vaccination, and hepatitis B vaccination in children remained low in several countries. A 2006 study concluded that evidence did not support an association between hepatitis B 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. Hepatitis B vaccination has not been linked to onset of autoimmune diseases in adulthood.
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 compared to 2022.
Hepatitis B (HepB3) immunization coverageamong one-year-olds worldwide Country 2017 Coverage2022 CoverageAfghanistan 6669Albania 9997Algeria 9177Andorra 9896Angola 5642Antigua and Barbuda 9599Argentina 8681Armenia 9496Australia 9594Austria 9084Azerbaijan 9583Bahamas 9487Bahrain 9897Bangladesh 9898Barbados 9086Belarus 9898Belgium 9797Belize 8884Benin 7676Bhutan 9898Bolivia (Plurinational State of) 8469Bosnia and Herzegovina 7778Botswana 9586Brazil 8277Brunei Darussalam 9999Bulgaria 9291Burkina Faso 9191Burundi 9191Côte d'Ivoire 8376Cabo Verde 9794Cambodia 9085Cameroon 7468Canada 7183Central African Republic 4242Chad 4160Chile 9396China 9999Colombia 9287Comoros 9188Congo 6978Cook Islands 9972Costa Rica 9794Croatia 9290Cuba 9999Cyprus 9794Czechia 9494Democratic People's Republic of Korea 970Democratic Republic of the Congo 7165Djibouti 7659Dominica 9192Dominican Republic 8187Ecuador 8570Egypt 9497El Salvador 9275Equatorial Guinea 5353Eritrea 9595Estonia 9285Eswatini 9097Ethiopia 6865Fiji 9199France 9095Gabon 7560Gambia 9279Georgia 9185Germany 8887Ghana 9999Greece 9696Grenada 9677Guatemala 9179Guinea 4747Guinea-Bissau 7974Guyana 9798Haiti 6451Honduras 9078India 8993Indonesia 8586Iran (Islamic Republic of) 9999Iraq 8193Ireland 9593Israel 9796Italy 9495Jamaica 9398Japanno data96Jordan 9977Kazakhstan 9999Kenya 8290Kiribati 9091Kuwait 9996Kyrgyzstan 9290Lao People's Democratic Republic 8480Latvia 9895Lebanon 8067Lesotho 8787Liberia 8078Libya 9673Lithuania 9490Luxembourg 9496Madagascar 6557Malawi 8886Malaysia 9896Maldives 9999Mali 7777Malta 8898Marshall Islands 8287Mauritania 7676Mauritius 9695Mexico 5883Micronesia (Federated States of) 8075Monaco 9999Mongolia 9995Montenegro 7345Morocco 9999Mozambique 8861Myanmar 8971Namibia 8884Nauru 8798Nepal 9090Netherlands 9288New Zealand 9489Nicaragua 9892Niger 8584Nigeria 5562Niue 9999North Macedonia 9184Norwayno data96Occupied Palestinian Territory, including east Jerusalem9999Oman 9999Pakistan 7585Palau 9887Panama 8187Papua New Guinea 3636Paraguay 9169Peru 8982Philippines 8072Poland 9390Portugal 9899Qatar 9798Republic of Korea 9897Republic of Moldova 8990Romania 9285Russian Federation 9797Rwanda 9898Saint Kitts and Nevis 9896Saint Lucia 8081Saint Vincent and the Grenadines 9999Samoa 6776San Marino 8291São Tomé and Príncipe 9597Saudi Arabia 9898Senegal 9388Serbia 9392Seychelles 9797Sierra Leone 9091Singapore 9696Slovakia 9697Sloveniano data89Solomon Islands 8389Somalia 4242South Africa 8485Spain 9493Sri Lanka 9998Sudan 9584Suriname 6777Sweden 7694Switzerland6976Syrian Arab Republic 4846Tajikistan 9697Thailand 9997Timor-Leste 8386Togo 8382Tonga 9999Trinidad and Tobago 8993Tunisia 9897Turkiye 9699Turkmenistan 9998Tuvalu 9691Uganda 9489Ukraine 5262United Arab Emirates 9895United Republic of Tanzania 9088United Kingdom of Great Britain and Northern Irelandno data92United States of America 9193Uruguay 9394Uzbekistan 9999Vanuatu 8568Venezuela (Bolivarian Republic of) 6656Viet Nam 9491Yemen 6874Zambia 9482Zimbabwe 8990