Hepatitis B vaccine is a

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...

that prevents

hepatitis B Hepatitis B is an infectious disease caused by the '' hepatitis B virus'' (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection. Many people have no symptoms during an initial infection. ...

. 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 The HIV, human immunodeficiency virus (HIV) is a retrovirus that attacks the immune system. Without treatment, it can lead to a spectrum of conditions including acquired immunodeficiency syndrome (AIDS). It is a Preventive healthcare, pr ...

and those born

premature Premature may refer to: * ''Premature'' (2014 film), an American comedy film * ''Premature'' (2019 film), an American romantic drama film * '' PREMature'', a 2015 British television drama miniseries See also * Premature aging, of an organism * ...

. 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 Hepatitis B virus (HBV) is a partially double-stranded DNA virus, a species of the genus '' Orthohepadnavirus'' and a member of the '' Hepadnaviridae'' family of viruses. This virus causes the disease hepatitis B. Classification Hepatitis B ...

(HBV) but not immunized,

hepatitis B immune globulin Hepatitis B immunoglobulin (HBIG) is a human immunoglobulin that is used to prevent the development of hepatitis B and is used for the treatment of acute exposure to HBsAg. Medical uses HBIG is indicated as a postexposure prophylaxis for people ...

should be given in addition to the vaccine. The vaccine is given by

injection into a muscle Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles have ...

. 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 Pregnancy is the time during which one or more offspring gestation, gestates inside a woman's uterus. A multiple birth, multiple pregnancy involves more than one offspring, such as with twins. Conception (biology), Conception usually occurs ...

or while

breastfeeding Breastfeeding, also known as nursing, is the process where breast milk is fed to a child. Infants may suck the milk directly from the breast, or milk may be extracted with a Breast pump, pump and then fed to the infant. The World Health Orga ...

. It has not been linked to

Guillain–Barré syndrome Guillain–Barré syndrome (GBS) is a rapid-onset Paralysis, muscle weakness caused by the immune system damaging the peripheral nervous system. Typically, both sides of the body are involved, and the initial symptoms are changes in sensation ...

. Hepatitis B vaccines are produced with

recombinant DNA Recombinant DNA (rDNA) molecules are DNA molecules formed by laboratory methods of genetic recombination (such as molecular cloning) that bring together genetic material from multiple sources, creating sequences that would not otherwise be fo ...

techniques and contain

immunologic adjuvant In immunology, an adjuvant is a substance that increases or modulates the immune response to a vaccine. The word "adjuvant" comes from the Latin word , meaning to help or aid. "An immunologic adjuvant is defined as any substance that acts to acce ...

. 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 WHO Model List of Essential Medicines (aka Essential Medicines List or EML), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health s ...

. Both versions were developed by

Maurice Hilleman Maurice Ralph Hilleman (August 30, 1919 – April 11, 2005) was a leading American microbiologist who specialized in vaccinology and developed over 40 vaccines, an unparalleled record of productivity. According to one estimate, his vaccines ...

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 Liver cancer, also known as hepatic cancer, primary hepatic cancer, or primary hepatic malignancy, is cancer that starts in the liver. Liver cancer can be primary in which the cancer starts in the liver, or it can be liver metastasis, or secondar ...

. This was reported in

Taiwan Taiwan, officially the Republic of China (ROC), is a country in East Asia. The main geography of Taiwan, island of Taiwan, also known as ''Formosa'', lies between the East China Sea, East and South China Seas in the northwestern Pacific Ocea ...

where the implementation of a nationwide hepatitis B vaccination program in 1984 was associated with a decline in the incidence of childhood

hepatocellular carcinoma Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults and is currently the most common cause of death in people with cirrhosis. HCC is the third leading cause of cancer-related deaths worldwide. HCC most common ...

. In the UK, the vaccine is offered to

men who have sex with men Men who have sex with men (MSM) are men who engage in sexual activity with other men, regardless of their sexual orientation or sexual identity. The term was created by epidemiologists in the 1990s, to better study and communicate the spre ...

(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 Recombinant may refer to: * Recombinant organism – an organism that contains a different combination of alleles from either of its parents. * Recombinant DNA – a form of artificial DNA sequence * Recombinant protein - artificially produced (and ...

(RV), seems to be able to elicit similar protective anti-HBs levels. The US

Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the National public health institutes, national public health agency of the United States. It is a Federal agencies of the United States, United States federal agency under the United S ...

(CDC) issued recommendations for vaccination against hepatitis B among patients with

diabetes mellitus Diabetes mellitus, commonly known as diabetes, is a group of common endocrine diseases characterized by sustained hyperglycemia, high blood sugar levels. Diabetes is due to either the pancreas not producing enough of the hormone insulin, or th ...

. The

World Health Organization The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...

(WHO) recommends a

pentavalent vaccine A pentavalent vaccine combines five vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of ...

, combining vaccines against

diphtheria Diphtheria is an infection caused by the bacteria, bacterium ''Corynebacterium diphtheriae''. Most infections are asymptomatic or have a mild Course (medicine), clinical course, but in some outbreaks, the mortality rate approaches 10%. Signs a ...

tetanus Tetanus (), also known as lockjaw, is a bacterial infection caused by ''Clostridium tetani'' and characterized by muscle spasms. In the most common type, the spasms begin in the jaw and then progress to the rest of the body. Each spasm usually l ...

pertussis Whooping cough ( or ), also known as pertussis or the 100-day cough, is a highly contagious, vaccine-preventable bacterial disease. Initial symptoms are usually similar to those of the common cold with a runny nose, fever, and mild cough, bu ...

and ''Haemophilus influenzae'' type B with the vaccine against hepatitis B. There is not yet 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

polio Poliomyelitis ( ), commonly shortened to polio, is an infectious disease caused by the poliovirus. Approximately 75% of cases are asymptomatic; mild symptoms which can occur include sore throat and fever; in a proportion of cases more severe ...

myelitis is approved in the U.S. and is recommended by the

Advisory Committee on Immunization Practices The Advisory Committee on Immunization Practices (ACIP) is a National Immunization Technical Advisory Group, committee within the United States Centers for Disease Control and Prevention (CDC) that provides advice and guidance on effective control ...

(ACIP). 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 effectiveness of being vaccinated during pregnancy to prevent

vertical transmission Vertical transmission of symbionts is the transfer of a microbial symbiont from the parent directly to the offspring. Many metazoan species carry symbiotic bacteria which play a mutualistic, commensal, or parasitic role. A symbiont is acq ...

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 Immunological memory is the ability of the immune system to quickly and specifically recognize an antigen that the body has previously encountered and initiate a corresponding immune response. Generally, they are secondary, tertiary and other subse ...

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

immunocompromise Immunodeficiency, also known as immunocompromise, is a state in which the immune system's ability to fight infectious diseases and cancer is compromised or entirely absent. Most cases are acquired ("secondary") due to extrinsic factors that affec ...

d people such as

haemodialysis Hemodialysis, also spelled haemodialysis, or simply ''"'dialysis'"'', is a process of filtering the blood of a person whose kidneys are not working normally. This type of dialysis achieves the extracorporeal removal of waste products such as c ...

patients,

HIV The human immunodeficiency viruses (HIV) are two species of '' Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the im ...

patients,

haematopoietic stem cell transplant Hematopoietic stem-cell transplantation (HSCT) is the transplantation of multipotent hematopoietic stem cells, usually derived from bone marrow, peripheral blood, or umbilical cord blood, in order to replicate inside a patient and produce add ...

SCTrecipients, or people receiving

chemotherapy Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs (list of chemotherapeutic agents, chemotherapeutic agents or alkylating agents) in a standard chemotherapy re ...

; and for sexual partners of HBsAg-positive people. An anti-Hbs antibody level above 100 mIU/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 Intradermal injection (also intracutaneous or intradermic, abbreviated as ID) is a shallow or superficial injection of a substance into the dermis, which is located between the epidermis and the hypodermis. For certain substances, administration ...

or to a high dose vaccine or to a double dose of a combined

hepatitis A Hepatitis A is an infectious liver disease caused by Hepatitis A virus (HAV); it is a type of viral hepatitis. Many cases have few or no symptoms, especially in the young. The time between infection and symptoms, in those who develop them, is ...

and B vaccine. Those who still fail to respond will require hepatitis B

immunoglobulin An antibody (Ab) or immunoglobulin (Ig) is a large, Y-shaped protein belonging to the immunoglobulin superfamily which is used by the immune system to identify and neutralize antigens such as pathogenic bacteria, bacteria and viruses, includin ...

(HBIG) if later exposed to the hepatitis B virus. Poor responses are mostly associated with being over the age of 40 years,

obesity Obesity is a medical condition, considered by multiple organizations to be a disease, in which excess Adipose tissue, body fat has accumulated to such an extent that it can potentially have negative effects on health. People are classifi ...

celiac disease Coeliac disease (British English) or celiac disease (American English) is a long-term autoimmune disorder, primarily affecting the small intestine. Patients develop intolerance to gluten, which is present in foods such as wheat, rye, spel ...

, and

tobacco smoking Tobacco smoking is the practice of burning tobacco and ingesting the resulting smoke. The smoke may be inhaled, as is done with cigarettes, or released from the mouth, as is generally done with pipes and cigars. The practice is believed to hav ...

, and also in

alcoholics Alcoholism is the continued drinking of alcohol despite it causing problems. Some definitions require evidence of dependence and withdrawal. Problematic use of alcohol has been mentioned in the earliest historical records. The World Hea ...

, especially if with advanced liver disease. People who are immunosuppressed or on

dialysis Dialysis may refer to: * Dialysis (chemistry), a process of separating molecules in solution **Electrodialysis, used to transport salt ions from one solution to another through an ion-exchange membrane under the influence of an applied electric po ...

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

. The immune response to the hepatitis B vaccine can be impaired by the presence of parasitic infections such as

helminthiasis Helminthiasis, also known as worm infection, is any macroparasite, macroparasitic disease of humans and other animals in which a part of the body is infected with parasitism, parasitic worms, known as helminths. There are numerous species of the ...

. 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. And these chronic HBV infections are life-threatening, with a 15–25% risk of death from complications.

Duration of protection

The Hepatitis B vaccine is now 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 Immunological memory is the ability of the immune system to quickly and specifically recognize an antigen that the body has previously encountered and initiate a corresponding immune response. Generally, they are secondary, tertiary and other subse ...

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

or while

. It has not been linked to

Multiple sclerosis

Several studies have looked for an association between recombinant hepatitis B vaccine and

multiple sclerosis Multiple sclerosis (MS) is an autoimmune disease resulting in damage to myelinthe insulating covers of nerve cellsin the brain and spinal cord. As a demyelinating disease, MS disrupts the nervous system's ability to Action potential, transmit ...

(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 Sudden infant death syndrome (SIDS), sometimes known as cot death or crib death, is the sudden unexplained death of a child of less than one year of age. Diagnosis requires that the death remain unexplained even after a thorough autopsy and ...

chronic fatigue syndrome Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a disabling Chronic condition, chronic illness. People with ME/CFS experience profound fatigue that does not go away with rest, as well as sleep issues and problems with memory ...

, 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

Immunization-hepb3-of-one-year-old-children

The following is a list of countries by the percentage of infants receiving three doses of hepatitis B vaccine as published by the

(WHO) in 2017 compared to 2022. According to the CDC, 34.2% of all adults over the age of 18 in the United States have received at least one HepB vaccine. Vaccine uptake varies across demographics such race, age, and travel status. With 53.5% of Asian adults aged 19–49 years having had at least one HepB vaccine compared to 48.4% of White adults, 34.4% of Black adults, and 37.5% of Hispanic adults. These numbers are lower for adults aged 30–59 years; with 47.0% of Asian adults aged 30–59 having had at least one HepB vaccine, 38.4% of White adults, 31.2% of Black adults, and 31.5% of Hispanic adults. The CDC also reports higher HepB vaccine uptake for adults who travel compared to those who do not, 43.1% compared to 28.7%.

History

Preliminary work

In 1963, the American physician/geneticist

Baruch Blumberg Baruch Samuel Blumberg (July 28, 1925 April 5, 2011), known as Barry Blumberg, was an American physician, geneticist, and co-recipient of the 1976 Nobel Prize in Physiology or Medicine (with Daniel Carleton Gajdusek), for his work on the hepa ...

, working at the

Fox Chase Cancer Center Fox Chase Cancer Center is a National Cancer Institute-designated Comprehensive Cancer Center research facility and hospital located in the Fox Chase section of Philadelphia, Pennsylvania, United States. The main facilities of the center are l ...

, discovered what he called the "Australia Antigen" (

HBsAg HBsAg (also known as the Australia antigen) is the surface antigen of the hepatitis B virus (HBV). Its presence in blood indicates existing hepatitis B infection. Structure and function The viral envelope of an enveloped virus has different su ...

) in the serum of an

Australia Australia, officially the Commonwealth of Australia, is a country comprising mainland Australia, the mainland of the Australia (continent), Australian continent, the island of Tasmania and list of islands of Australia, numerous smaller isl ...

n Aboriginal person. In 1968, this protein was found to be part of the virus that causes "serum hepatitis" (hepatitis B) by

virologist Virology is the scientific study of biological viruses. It is a subfield of microbiology that focuses on their detection, structure, classification and evolution, their methods of infection and exploitation of host cells for reproduction, the ...

Alfred Prince. In 1976, Blumberg won the

Nobel Prize in Physiology or Medicine The Nobel Prize in Physiology or Medicine () is awarded yearly by the Nobel Assembly at the Karolinska Institute for outstanding discoveries in physiology or medicine. The Nobel Prize is not a single prize, but five separate prizes that, acco ...

for his work on hepatitis B (sharing it with

Daniel Carleton Gajdusek Daniel Carleton Gajdusek ( ;Holley, Joe (December 16, 2008) "D. Carleton Gajdusek; Controversial Scientist", ''The Washington Post'', p. B5. September 9, 1923 – December 12, 2008) was an American physician and medical researcher who was the co ...

for his work on kuru). Blumberg had identified Australia antigen, the important first step, and later discovered the way to make the first hepatitis B vaccine. Blumberg's vaccine was a unique approach to the production of a vaccine; that is, obtaining the immunizing antigen directly from the blood of human carriers of the virus. In October 1969, acting on behalf of the Institute for Cancer Research, they applied for a patent for the production of a vaccine. This patent

SP 3,636,191 Sp or SP may refer to: Arts and entertainment * /sp/, the sports board on the Internet forum 4chan * ''SP'' (TV series), a Japanese TV series * Game Boy Advance SP, an upgraded version of the Game Boy Advance handheld video game system, released ...

was subsequently (January 1972) granted in the United States and other countries. In 2002, Blumberg published a book, ''Hepatitis B: The Hunt for a Killer Virus''. In the book, Blumberg wrote: “It took some time before the concept was accepted by virologists and vaccine manufacturers who were more accustomed to dealing with vaccines produced by attenuation of viruses, or the use of killed viruses produced in tissue culture, or related viruses that were non-pathogenic protective (i.e., smallpox). However, by 1971, we were able to interest Merck, which had considerable experience with vaccines."

Blood-derived vaccine

During the next few years, a series of human and primate observations by scientists including

(who was responsible for vaccines at Merck), S. Krugman, R. Purcell, P. Maupas, and others provided additional support for the vaccine. In 1980, the results of the first field trial were published by W. Szmuness and his colleagues in New York City. The American microbiologist/vaccinologist Maurice Hilleman at Merck used three treatments (

pepsin Pepsin is an endopeptidase that breaks down proteins into smaller peptides and amino acids. It is one of the main digestive enzymes in the digestive systems of humans and many other animals, where it helps digest the proteins in food. Pe ...

urea Urea, also called carbamide (because it is a diamide of carbonic acid), is an organic compound with chemical formula . This amide has two Amine, amino groups (–) joined by a carbonyl functional group (–C(=O)–). It is thus the simplest am ...

and

formaldehyde Formaldehyde ( , ) (systematic name methanal) is an organic compound with the chemical formula and structure , more precisely . The compound is a pungent, colourless gas that polymerises spontaneously into paraformaldehyde. It is stored as ...

) 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, due to their high-risk status. Later, Hilleman's vaccine was falsely blamed for igniting the AIDS epidemic. (See

Wolf Szmuness Wolf Szmuness (March 12, 1919 – June 6, 1982) was a Polish-born epidemiology, epidemiologist who immigrated to and worked in the United States. He conducted research at the New York Blood Center and, from 1973, he was director of the Center's epi ...

) 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.

Recombinant vaccine

The blood-derived hepatitis B vaccine was withdrawn from the marketplace in 1986, replaced by

's improved recombinant hepatitis B vaccine which was approved by the

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

on 23 July 1986. It was the first human vaccine produced by recombinant DNA methods. For this work, scientists at Merck & Co. collaborated with

William J. Rutter William J. Rutter (born August 28, 1928) is an American biochemist who cofounded the early biotechnology company Chiron Corporation together with Edward Penhoet and Pablo DT Valenzuela. As chairman of the department of biochemistry and biophy ...

and colleagues at the

University of California at San Francisco The University of California, San Francisco (UCSF) is a public land-grant research university in San Francisco, California, United States. It is part of the University of California system and is dedicated entirely to health science and life s ...

, as well as Benjamin Hall and colleagues at the

University of Washington The University of Washington (UW and informally U-Dub or U Dub) is a public research university in Seattle, Washington, United States. Founded in 1861, the University of Washington is one of the oldest universities on the West Coast of the Uni ...

. In 1981, William J. Rutter,

Pablo DT Valenzuela Pablo Valenzuela (; born June 13, 1941) is a Chilean biochemist dedicated to biotechnology development. He is known for his genetic studies of hepatitis viruses; participated as a research and development director in the discovery of hepatitis C ...

and Edward Penhoet (

UC Berkeley The University of California, Berkeley (UC Berkeley, Berkeley, Cal, or California), is a public land-grant research university in Berkeley, California, United States. Founded in 1868 and named after the Anglo-Irish philosopher George Berkele ...

) co-founded the

Chiron Corporation Chiron Corporation ( ) was an American multinational biotechnology firm founded in 1981, based in Emeryville, California, that was acquired by Novartis on April 20, 2006. It had offices and facilities in eighteen countries on five continents. C ...

Emeryville, California Emeryville is a city located in northwest Alameda County, California, in the United States. It lies in a corridor between the cities of Berkeley, California, Berkeley and Oakland, California, Oakland, with a border on the shore of San Francisc ...

, which collaborated with Merck. The recombinant vaccine is based on a Hepatitis B surface antigen (

) gene inserted into

yeast Yeasts are eukaryotic, single-celled microorganisms classified as members of the fungus kingdom (biology), kingdom. The first yeast originated hundreds of millions of years ago, and at least 1,500 species are currently recognized. They are est ...

(''

Saccharomyces cerevisiae ''Saccharomyces cerevisiae'' () (brewer's yeast or baker's yeast) is a species of yeast (single-celled fungal microorganisms). The species has been instrumental in winemaking, baking, and brewing since ancient times. It is believed to have be ...

'') cells which are free of any concerns associated with human blood products. This allows the yeast to produce only the noninfectious surface protein, without any danger of introducing actual viral DNA into the final product. The vaccine contains the

adjuvant In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Anal ...

amorphous aluminum hydroxyphosphate sulfate. In 2017, a two-dose HBV vaccine for adults, Heplisav-B gained U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) approval. 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 concerning immunogenicity. In November 2021, Hepatitis B Vaccine (Recombinant) (Prehevbrio) was approved by the FDA.

Immunization schedule

The US CDC ACIP first recommended the vaccine for all newborns in 1991. Before this, the vaccine was only recommended for high-risk groups. As of the 1991 recommendation for universal newborn Hepatitis B vaccination, no other vaccines were routinely recommended for all newborns in the United States and remains one of the very few vaccines routinely recommended for administration at birth. The CDC has varying Hepatitis B vaccination schedule recommendations depending on the birth weight of the infant and Hepatitis B status of the birth mother. For infants born to mothers with a negative Hepatitis B antigen test, who weight at least 2000 grams, the first Hepatitis B vaccination is recommended in the first 24 hours of life, the second dose between 1 and 2 months, and the third dose between 6 and 18 months. For infants born to mothers with a negative Hepatitis B antigen test, who weight less than 2000 grams, the first Hepatitis B vaccination is recommended at 1 months of age or hospital discharge (whichever comes first). For infants born to Hepatitis B positive mothers, Hepatitis B vaccine is recommended in the first 12 hours of birth as well as administration of Hepatitis B immune globulin. For infants born to mothers with an unknown Hepatitis B status, Hepatitis B vaccination is recommended in the first 12 hours of life. For infants born to mothers with positive or unknown Hepatitis B status, a follow up screening is recommended between 9 and 12 months.

Manufacture

The vaccine contains one of the viral envelope

proteins Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, re ...

, Hepatitis B surface antigen (

). It is produced by yeast cells, into which the gene for HBsAg has been inserted. Afterward an immune system

antibody An antibody (Ab) or immunoglobulin (Ig) is a large, Y-shaped protein belonging to the immunoglobulin superfamily which is used by the immune system to identify and neutralize antigens such as pathogenic bacteria, bacteria and viruses, includin ...

to HBsAg is established in the bloodstream. The antibody is known as ''anti-HBs''. This antibody and immune system memory then provide immunity to hepatitis B virus (HBV) infection.

Society and culture

Legal status

On 10 December 2020, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

(CHMP) of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

(EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product HeplisavB, intended for the active immunization against hepatitisB virus infection (HBV). Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. The applicant for this medicinal product is Dynavax GmbH. It was approved for medical use in the European Union in February 2021. On 24 February 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product PreHevbri, intended for the active immunization against hepatitis B virus infection (HBV). The applicant for this medicinal product is VBI Vaccines B.V. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. PreHevbri was approved for medical use in the European Union in April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

Brand names

The common brands available are Recombivax HB ( Merck), Engerix-B ( GSK), Elovac B (Human Biologicals Institute, a division of

Indian Immunologicals Limited Indian Immunologicals Limited (IIL) is a subsidiary of the National Dairy Development Board. It is based in Hyderabad, Telangana, India. IIL is registered in India as a Public Limited Company under the Companies Act, 1956 (Ministry of Corporate ...

), Genevac B ( Serum Institute), Shanvac B, Heplisav-B, Prehevbrio, and Euvax B (LG Chem).

Twinrix Combined hepatitis A vaccine, hepatitis A and hepatitis B vaccine, B vaccine, is used to provide protection against hepatitis A and hepatitis B. It is given by injection intramuscular, into muscle. It is used in areas where hepatitis A and B ar ...

( GSK) is a vaccine against

and hepatitis B.

Pediarix DTaP-IPV-HepB vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated polio vaccine or DTaP- IPV- Hep B. It protects against the infecti ...

is a vaccine against

, hepatitis B, and

myelitis.

Vaxelis A hexavalent vaccine, or 6-in-1 vaccine, is a combination vaccine with six individual vaccines conjugated into one, intended to protect people from multiple diseases. The term usually refers to the children's vaccine that protects against diph ...

is a vaccine against diphtheria, tetanus, pertussis, poliomyelitis, ''Haemophilus influenzae'' type B (Meningococcal Protein Conjugate), and hepatitis B. Fendrix (hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)) was approved for medical use in the European Union in 2005.

References

External links

* * {{DEFAULTSORT:Hepatitis B Vaccine Hepatitis B Cancer vaccines Drugs developed by GSK plc Drugs developed by Merck & Co. Recombinant proteins Subunit vaccines Hepatitis vaccines World Health Organization essential medicines (vaccines) Wikipedia medicine articles ready to translate