Hepatitis B vaccine
Vaccine description | |
---|---|
Target | Hepatitis B virus |
Vaccine type | Subunit |
Clinical data | |
Trade names | Recombivax HB, Engerix-B, Heplisav-B, others |
AHFS/Drugs.com | Monograph |
MedlinePlus | a607014 |
License data | |
Pregnancy category |
|
Intramuscular (IM) | |
Drug class | Antiviral |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
PubChem CID | |
DrugBank | |
ChemSpider |
|
UNII | |
KEGG | |
(what is this?) (verify) |
Hepatitis B vaccine is a
Blood testing to verify that the vaccine has worked is recommended in those at high risk.
Serious side effects from the hepatitis B vaccine are very uncommon.[13] Pain may occur at the site of injection.[13] It is safe for use during pregnancy or while breastfeeding.[13] It has not been linked to Guillain–Barré syndrome.[13] Hepatitis B vaccines are produced with recombinant DNA techniques and contain immunologic adjuvant.[13] They are available both by themselves and in combination with other vaccines.[13]
The first hepatitis B vaccine was approved in the United States in 1981.[15] A recombinant version came to market in 1986.[13] It is on the World Health Organization's List of Essential Medicines.[16][17] Both versions were developed by Maurice Hilleman and his team.[18][19][20]
Medical uses
In the United States vaccination is recommended for nearly all babies at birth.[21] 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.[22]
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.[23]
In many areas, vaccination against hepatitis B is also required for all health-care and laboratory staff.
The US
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).[30] The combination is superior for protecting these infants.[30] The effectiveness of being vaccinated during pregnancy to prevent vertical transmission of hepatitis B to infants has not been studied.[31] Hepatitis B immunoglobulin before birth has not been well studied.[32]
Effectiveness
Studies have found that that
An anti-Hbs antibody level above 100
Poor responses are mostly associated with being over the age of 40 years,
Duration of protection
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,
Side effects
Serious side effects from the hepatitis B vaccine are very rare.[13] Pain may occur at the site of injection.[13] It is generally considered safe for use, during pregnancy or while breastfeeding.[13][47] It has not been linked to Guillain–Barré syndrome.[13]
Multiple sclerosis
Several studies have looked for an association between recombinant hepatitis B vaccine and
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.[56]
Hepatitis B (HepB3) immunization coverage among one-year-olds worldwide | |
---|---|
Country | Coverage % |
Afghanistan | 65 |
Albania | 99 |
Algeria | 91 |
Andorra | 98 |
Angola | 52 |
Antigua and Barbuda | 95 |
Argentina | 86 |
Armenia | 94 |
Australia | 95 |
Austria | 90 |
Azerbaijan | 95 |
Bahamas | 94 |
Bahrain | 98 |
Bangladesh | 97 |
Barbados | 90 |
Belarus | 98 |
Belgium | 97 |
Belize | 88 |
Benin | 82 |
Bhutan | 98 |
Bolivia (Plurinational State of) | 83 |
Bosnia and Herzegovina | 77 |
Botswana | 95 |
Brazil | 93 |
Brunei Darussalam | 99 |
Bulgaria | 92 |
Burkina Faso | 91 |
Burundi | 91 |
Côte d'Ivoire | 84 |
Cabo Verde | 86 |
Cambodia | 93 |
Cameroon | 86 |
Canada | 69 |
Central African Republic | 47 |
Chad | 41 |
Chile | 93 |
China | 99 |
Colombia | 92 |
Comoros | 91 |
Congo | 69 |
Cook Islands | 99 |
Costa Rica | 97 |
Croatia | 94 |
Cuba | 99 |
Cyprus | 97 |
Czech Republic | 94 |
Democratic People's Republic of Korea | 97 |
Democratic Republic of the Congo | 81 |
Djibouti | 68 |
Dominica | 91 |
Dominican Republic | 81 |
Ecuador | 84 |
Egypt | 94 |
El Salvador | 85 |
Equatorial Guinea | 25 |
Eritrea | 95 |
Estonia | 92 |
Eswatini | 90 |
Ethiopia | 73 |
Fiji | 99 |
France | 90 |
Gabon | 75 |
Gambia | 92 |
Georgia | 91 |
Germany | 87 |
Ghana | 99 |
Greece | 96 |
Grenada | 96 |
Guatemala | 82 |
Guinea | 45 |
Guinea-Bissau | 87 |
Guyana | 97 |
Haiti | 58 |
Honduras | 97 |
India | 88 |
Indonesia | 79 |
Iran (Islamic Republic of) | 99 |
Iraq | 63 |
Ireland | 95 |
Israel | 97 |
Italy | 94 |
Jamaica | 93 |
Jordan | 99 |
Kazakhstan | 99 |
Kenya | 82 |
Kiribati | 90 |
Kuwait | 99 |
Kyrgyzstan | 92 |
Lao People's Democratic Republic | 85 |
Latvia | 98 |
Lebanon | 78 |
Lesotho | 93 |
Liberia | 86 |
Libya | 94 |
Lithuania | 94 |
Luxembourg | 94 |
Macedonia | 91 |
Madagascar | 74 |
Malawi | 88 |
Malaysia | 98 |
Maldives | 99 |
Mali | 66 |
Malta | 88 |
Marshall Islands | 82 |
Mauritania | 81 |
Mauritius | 96 |
Mexico | 93 |
Micronesia (Federated States of) | 80 |
Monaco | 99 |
Mongolia | 99 |
Montenegro | 73 |
Morocco | 99 |
Mozambique | 80 |
Myanmar | 89 |
Namibia | 88 |
Nauru | 87 |
Nepal | 90 |
Netherlands | 92 |
New Zealand | 94 |
Nicaragua | 98 |
Niger | 81 |
Nigeria | 42 |
Niue | 99 |
Oman | 99 |
Pakistan | 75 |
Palau | 98 |
Panama | 81 |
Papua New Guinea | 56 |
Paraguay | 91 |
Peru | 83 |
Philippines | 88 |
Poland | 95 |
Portugal | 98 |
Qatar | 97 |
Republic of Korea | 98 |
Republic of Moldova | 89 |
Romania | 92 |
Russian Federation | 97 |
Rwanda | 98 |
Saint Kitts and Nevis | 98 |
Saint Lucia | 80 |
Saint Vincent and the Grenadines | 99 |
Samoa | 73 |
San Marino | 86 |
São Tomé and Príncipe | 95 |
Saudi Arabia | 98 |
Senegal | 91 |
Serbia | 93 |
Seychelles | 98 |
Sierra Leone | 90 |
Singapore | 96 |
Slovakia | 96 |
Solomon Islands | 99 |
Somalia | 42 |
South Africa | 66 |
Spain | 93 |
Sri Lanka | 99 |
Sudan | 95 |
Suriname | 81 |
Swaziland | 98 |
Sweden | 76 |
Syrian Arab Republic | 52 |
Tajikistan | 96 |
Thailand | 99 |
Timor-Leste | 76 |
Togo | 90 |
Tonga | 81 |
Trinidad and Tobago | 89 |
Tunisia | 98 |
Turkey | 96 |
Turkmenistan | 99 |
Tuvalu | 96 |
Uganda | 85 |
Ukraine | 52 |
United Arab Emirates | 98 |
United Republic of Tanzania | 97 |
United States of America | 93 |
Uruguay | 95 |
Uzbekistan | 99 |
Vanuatu | 85 |
Venezuela (Bolivarian Republic of) | 84 |
Viet Nam | 94 |
Yemen | 68 |
Zambia | 94 |
Zimbabwe | 89 |
History
Preliminary work
In 1963, the American physician/geneticist
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).[59] 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 filed an application for a patent for the production of a vaccine. This patent [USP 3,636,191] 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.[60] 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 Maurice Hilleman (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, 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.[61]
Hilleman collected blood from gay men and
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.[61] The vaccine was approved in 1981.[18]
Recombinant vaccine
The blood-derived hepatitis B vaccine was withdrawn from the marketplace in 1986, replaced by
The recombinant vaccine is based on Hepatitis B surface antigen (HBsAg) gene inserted into yeast (Saccharomyces cerevisiae) cells which are free of any concerns associated with human blood products.[18][65] This allows the yeast to produce only the noninfectious surface protein, without any danger of introducing actual viral DNA into the final product.[61] The vaccine contains the adjuvant amorphous aluminum hydroxyphosphate sulfate.[65]
In 2017, a two-dose HBV vaccine for adults, Heplisav-B gained U.S. Food and Drug Administration (FDA) approval.[4] 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.[66]
In November 2021, Hepatitis B Vaccine (Recombinant) (Prehevbrio) was approved by the FDA.[7][67][68][69]
Immunization schedule
The US CDC ACIP first recommended the vaccine for all newborns in 1991.[70] Prior to 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.
Manufacture
The vaccine contains one of the viral envelope
Society and culture
Legal status
On 10 December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Heplisav B, intended for the active immunization against hepatitis B virus infection (HBV).[72] The applicant for this medicinal product is Dynavax GmbH.[72] It was approved for medical use in the European Union in February 2021.[9]
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).[73] The applicant for this medicinal product is VBI Vaccines B.V.[73] PreHevbri was approved for medical use in the European Union in April 2022.[10][12]
Brand names
The common brands available are Recombivax HB (
Fendrix (hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)) was approved for medical use in the European Union in 2005.[79]
References
- ^ "Hepatitis b adult vaccine Pregnancy and Breastfeeding Warnings". Drugs.com. 27 April 2020. Archived from the original on 27 October 2020. Retrieved 19 December 2021.
- ^ "Engerix B SmPC". Datapharm. 24 April 2017. Archived from the original on 22 September 2019. Retrieved 22 September 2019.
- ^ "HBVaxPro SmPC". Datapharm. 12 March 2019. Archived from the original on 22 September 2019. Retrieved 22 September 2019.
- ^ a b c "Heplisav-B". U.S. Food and Drug Administration (FDA). Archived from the original on 22 September 2019. Retrieved 22 September 2019.
- ^ a b "Recombivax HB". U.S. Food and Drug Administration (FDA). 24 April 2019. Archived from the original on 11 February 2020. Retrieved 6 May 2020.
- ^ a b "Engerix-B". U.S. Food and Drug Administration (FDA). 3 October 2019. Archived from the original on 11 February 2020. Retrieved 6 May 2020.
- ^ a b c "PreHevbrio". U.S. Food and Drug Administration. 13 December 2021. Archived from the original on 19 December 2021. Retrieved 19 December 2021.
- ^ "Hepatitis B Vaccine Monograph for Professionals". Drugs.com. 1 September 2019. Archived from the original on 21 October 2019. Retrieved 19 December 2019.
- ^ a b c "Heplisav B EPAR". European Medicines Agency (EMA). 9 December 2020. Archived from the original on 8 March 2021. Retrieved 1 March 2021.
- ^ a b "PreHevbri EPAR". European Medicines Agency (EMA). 22 February 2022. Retrieved 3 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Heplisav B Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ a b "PreHevbri Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ PMID 28685564.
- ^ PMID 16235273.
- ISBN 9780123983756.
- hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
- hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
- ^ PMC 7150172.
- S2CID 46630955.
- ^ a b Offit PA (2007). "Chapter 8: Blood". Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases (PDF). HarperCollins. pp. 115–126, 136–140. Archived (PDF) from the original on 5 October 2021. Retrieved 9 January 2021.
- PMID 28847980.
- PMID 9197213.
- ^ "Hepatitis B vaccine". Nhs.uk. Archived from the original on 28 June 2017. Retrieved 27 April 2017.
- ISBN 978-0-11-322528-6. Archived from the original(PDF) on 7 January 2013. Retrieved 25 March 2008.
- (PDF) from the original on 17 October 2020. Retrieved 7 May 2020.
- PMID 22513932.
- PMID 12653460.
- (PDF) from the original on 7 May 2020. Retrieved 7 May 2020.
- (PDF) from the original on 3 July 2020. Retrieved 7 May 2020.
- ^ PMID 16625613.
- PMID 25385500.
- PMID 28188612.
- ^ a b "Ask the Experts: Hepatitis B". Immunize.org. Immunization Action Coalition. 26 May 2022. Archived from the original on 16 October 2022. Retrieved 25 September 2022.
- ^ ISBN 978-0-11-322528-6. Archived from the original(PDF) on 7 January 2013.
- ^ PMID 25132754.
- PMID 7759824.
- PMID 18544037.
- PMID 8254852.
- PMID 9316554.
- PMID 16571140. 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 afterwards
- PMID 3660859.
- from the original on 5 June 2015.
- PMID 17298912.
- PMID 26802140.
- PMID 17291637.
- S2CID 32401362.
- PMID 23002336.
- ^ S2CID 20362426.
- ^ "FAQs about Hepatitis B Vaccine (Hep B) and Multiple Sclerosis". U.S. Centers for Disease Control and Prevention (CDC). 9 October 2009. Archived from the original on 10 November 2009.
- PMID 29454521.
- S2CID 25309517.
- S2CID 45526262.
- PMID 18056563.
- S2CID 51967163.
- ^ "Share of one-year-olds vaccinated against hepatitis B". Our World in Data. Archived from the original on 21 April 2020. Retrieved 22 April 2020.
- ^ "Hepatitis B (HepB3) Immunization coverage estimates by country". WHO. Archived from the original on 11 May 2016. Retrieved 8 June 2016.
- PMID 14239025.
- ISBN 978-0-12-782150-4.
- ^ "The Nobel Prize in Physiology or Medicine 1976". NobelPrize.org. Archived from the original on 23 May 2020. Retrieved 14 February 2021.
- ^ Blumberg, Baruch (2002), Hepatitis B: The Hunt for a Killer Virus, Princeton: Princeton University Press.
- ^ a b c d "World Hepatitis Day: The History of the Hepatitis B Vaccine | Planned Parenthood Advocates of Arizona". Blog.advocatesaz.org. 26 July 2012. Archived from the original on 5 April 2016. Retrieved 27 April 2017.
- ^ a b "Vaccine Development & Licensing Events". History of Vaccines. Archived from the original on 16 April 2022. Retrieved 14 February 2021.
- ^ a b "THE HEPATITIS B STORY" (PDF). National Academy of Sciences. February 2000. Archived (PDF) from the original on 28 July 2021.
- from the original on 26 August 2017. Retrieved 14 February 2021.
- ^ a b c "Hepatitis B Vaccine from Merck". Archived from the original on 21 April 2010. Retrieved 9 May 2010.
- ^ Dynavax Technologies Corp. "Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] label" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on 25 April 2018. Retrieved 27 November 2018.
- ^ "ACIP Evidence to Recommendations for use of PreHevbrio Hepatitis B (HepB) Vaccine in Adults". U.S. Centers for Disease Control and Prevention (CDC). 31 March 2022. Archived from the original on 18 August 2022. Retrieved 15 February 2023.
- ^ "Grading of Recommendations Assessment, Development and Evaluation (GRADE): PreHevbrio for Adults". U.S. Centers for Disease Control and Prevention (CDC). 31 March 2022. Archived from the original on 3 December 2022. Retrieved 15 February 2023.
- (PDF) from the original on 9 February 2023. Retrieved 16 February 2023.
- PMID 1835756. Retrieved 15 May 2023.
- ^ "CDC Viral Hepatitis". U.S. Centers for Disease Control and Prevention (CDC). 24 July 2009. Archived from the original on 20 October 2009. Retrieved 22 October 2009.
- ^ a b "Heplisav B: Pending EC decision". European Medicines Agency (EMA). 10 December 2020. Archived from the original on 11 December 2020. Retrieved 11 December 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "PreHevbri: Pending EC decision". European Medicines Agency (EMA). 25 February 2022. Archived from the original on 27 February 2022. Retrieved 27 February 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Hepatitis A & hepatitis B recombinant vaccine - Drug Summary". www.pdr.net. Prescriber's Digital Reference. Archived from the original on 4 June 2019. Retrieved 4 June 2019.
- ^ "Twinrix". U.S. Food and Drug Administration (FDA). Archived from the original on 22 September 2019. Retrieved 22 September 2019.
- ^ "Pediarix". U.S. Food and Drug Administration (FDA). Archived from the original on 22 September 2019. Retrieved 22 September 2019.
- ^ "Vaxelis EPAR". European Medicines Agency (EMA). 19 February 2019. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
- ^ "Vaxelis". U.S. Food and Drug Administration (FDA). STN 125563. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
- ^ "Fendrix EPAR". European Medicines Agency (EMA). 2 February 2005. Retrieved 27 December 2023.
Further reading
- Ramsay M, ed. (2019). "Chapter 18: Hepatitis B". Immunisation Against Infectious Disease. Public Health England.
- Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S, eds. (2021). "Chapter 10: Hepatitis B". Epidemiology and Prevention of Vaccine-Preventable Diseases (14th ed.). Washington D.C.: U.S. Centers for Disease Control and Prevention (CDC).
External links
- "Hepatitis B Vaccine Information Statement". U.S. Centers for Disease Control and Prevention (CDC). October 2021.
- Hepatitis B Vaccines at the U.S. National Library of Medicine Medical Subject Headings (MeSH)