DTwP-HepB-Hib vaccine
{{Short description|Combination vaccine}}
{{Use dmy dates|date=October 2023}}
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| component1 = DTP vaccine
| class1 = Vaccine
| component2 = Hepatitis B vaccine
| class2 = Vaccine
| component3 = Haemophilus vaccine
| class3 = Vaccine
| tradename = Quintavax, Pentavac, Pentacel, others
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| routes_of_administration = Intramuscular injection
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| ATC_prefix = J07
| ATC_suffix = CA11
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| index_label = Quintavax
| index2_label = Pentavac
| CAS_number = 1196465-46-9
| CAS_number2 = 1688606-53-2
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DTwP-HepB-Hib vaccine is a 5-in-1 combination vaccine with five individual vaccines conjugated into one. It protects against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type B, which is generally used in middle- and low-income countries, where polio vaccine is given separately.{{cite book | author1 = World Health Organization | author2 = World Health Organization Department of Immunization, Vaccines and Biologicals|title=Immunization in Practice: A Practical Guide for Health Staff |date=2004 |publisher=World Health Organization |isbn=9789241546515 |page=20 |url=https://books.google.com/books?id=cBBIreR5YR4C&q=DTP-HepB+vaccine&pg=PT20 |access-date=15 July 2018 |language=en}}{{cite journal|vauthors=Malhame M, Baker E, Gandhi G, Jones A, Kalpaxis P, Iqbal R, Momeni Y, Nguyen A|date=August 2019|title=Shaping markets to benefit global health - A 15-year history and lessons learned from the pentavalent vaccine market|journal=Vaccine|volume=2|pages=100033|doi=10.1016/j.jvacx.2019.100033|pmc=6668221|pmid=31384748}}
By 2013, pentavalent vaccines accounted for 100% of the DTP-containing vaccines procured by UNICEF, which supplies vaccines to a large proportion of the world's children.{{cite web|url=https://www.unicef.org/supply/files/Diphtheria_Tetanus_And_Pertussis_DTP_Vaccine_-_October_2016.pdf|title=Diphtheria Tetanus and Pertussis Vaccine Supply Update|date=October 2016|access-date=28 June 2018|website=UNICEF|archive-date=29 June 2018|archive-url=https://web.archive.org/web/20180629074353/https://www.unicef.org/supply/files/Diphtheria_Tetanus_And_Pertussis_DTP_Vaccine_-_October_2016.pdf|url-status=dead}}
Safety
During studies and tests, the conjugated liquid DTPw-HepB-Hib vaccine was found to have positive safety when given as a booster to young children who have been given a vaccination course with another pentavalent booster that requires a change in constitution and was also found to be adequately immunogenic.{{cite journal | vauthors = Suárez E, Asturias EJ, Hilbert AK, Herzog C, Aeberhard U, Spyr C | title = A fully liquid DTPw-HepB-Hib combination vaccine for booster vaccination of toddlers in El Salvador | journal = Revista Panamericana de Salud Pública | volume = 27 | issue = 2 | pages = 117–24 | date = February 2010 | pmid = 20339615 | doi = 10.1590/S1020-49892010000200005 | doi-broken-date = 14 November 2024 | doi-access = free }}
History
In October 2004, the European Medicines Agency granted marketing approval to the pentavalent vaccine Quintanrix, manufactured by GlaxoSmithKline.{{cite web|url=http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000556/WC500057286.pdf|title=Quintanrix : EPAR - Summary for the public|publisher=European Medicines Agency|access-date=15 July 2018|archive-date=15 July 2018|archive-url=https://web.archive.org/web/20180715210803/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000556/WC500057286.pdf|url-status=dead}} Quintanrix was voluntarily withdrawn by the manufacturer in 2008.{{cite web|url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000556/human_med_001006.jsp&mid=WC0b01ac058001d124|title=Public statement on Quintanrix: Withdrawal of the marketing authorisation in the European Union|publisher=European Medicines Agency|date=29 August 2008|access-date=15 July 2018|archive-date=15 July 2018|archive-url=https://web.archive.org/web/20180715210610/http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Fhuman%2Fmedicines%2F000556%2Fhuman_med_001006.jsp&mid=WC0b01ac058001d124|url-status=dead}}{{cite web | title=Quintanrix EPAR | website=European Medicines Agency | date=25 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/quintanrix | access-date=13 October 2023}}
In September 2006, the first pentavalent vaccine formulation received pre-qualification approval from the World Health Organization.
In 2012, UNICEF and the World Health Organization issued and recommended a joint statement to the Immunization Division, Ministry of Health and Family Welfare, Government of India and other developing nations in separate documents about the use of pentavalent vaccines to protect against five of the leading causes of vaccine-preventable death in children.{{cite web |url=http://www.searo.who.int/india/topics/routine_immunization/Pentavalent_vaccine_Guide_for_HWs_with_answers_to_FAQs.pdf |title=Pentavalent Vaccine |work=World Health Organization }}
By 2013, pentavalent vaccines accounted for 100% of the DTP-containing vaccines procured by UNICEF, which supplies vaccines to a large proportion of the world's children.
In 2014, South Sudan became the last of the 73 GAVI-supported countries to introduce the five-in-one vaccine.{{cite web |url=http://www.gavialliance.org/support/nvs/pentavalent/ |title=With GAVI support, pentavalent vaccine is available in the 73 poorest countries |work=GAVI Alliance |access-date=2015-12-07 |archive-date=2014-07-18 |archive-url=https://web.archive.org/web/20140718215103/http://www.gavialliance.org/support/nvs/pentavalent/ |url-status=dead }}
Society and culture
In May 2010, Crucell N.V. announced a US$110 million award from UNICEF to supply its pentavalent pediatric vaccine Quinvaxem to the developing world.{{cite press release |url=http://www.prnewswire.com/news-releases/crucell-announces-new-award-of-110-million-for-paediatric-vaccine-quinvaxemr-by-unicef-to-support-vaccination-programs-in-the-developing-world-92964189.html |title=Crucell Announces New Award of $110 Million... |work=PRNewswire }}
In November 2010, the public-private consortium GAVI announced that the cost of the pentavalent vaccine for emerging-market countries had dropped below US$3.00 per dose.{{cite web|url=https://www.gavi.org/library/news/press-releases/2010/price-of-life-saving-vaccine-expected-to-drop-significantly-in-2011/|website=GAVI|access-date=3 July 2018|title=Price of life-saving vaccine expected to drop significantly in 2011|date=26 November 2010}}
High-income countries tend to use alternative formulations using acellular pertussis (Pa), which has a more favourable profile of side-effects, rather than whole-cell pertussis components.{{cite web|url=https://www.who.int/immunization/programmes_systems/procurement/market/individual_vaccine/en/|archive-url=https://web.archive.org/web/20150211210026/http://www.who.int/immunization/programmes_systems/procurement/market/individual_vaccine/en/|url-status=dead|archive-date=February 11, 2015|access-date=28 June 2018|website=World Health Organization|title=Vaccine Market}}{{cite web|url=http://vk.ovg.ox.ac.uk/5-1-dtapipvhib-vaccine|access-date=3 July 2018|title=5-in-1 Vaccine (also called Pentavalent Vaccine)|website=Vaccine Knowledge Project|date=22 March 2018}} In Europe, hexavalent vaccines that also contain inactivated polio vaccine (IPV) are in wide use.{{cite journal | vauthors = Obando-Pacheco P, Rivero-Calle I, Gómez-Rial J, Rodríguez-Tenreiro Sánchez C, Martinón-Torres F | title = New perspectives for hexavalent vaccines | journal = Vaccine | volume = 36 | issue = 36 | pages = 5485–5494 | date = August 2018 | pmid = 28676382 | doi = 10.1016/j.vaccine.2017.06.063 | s2cid = 4384043 }}
File:Prequalified pentavalent and years of sales to UNICEF. Figure 5.jpg|alt=The number of manufacturers making certified pentavalent vaccine.|The number of manufacturers making certified pentavalent vaccine{{cite journal | vauthors = Malhame M, Baker E, Gandhi G, Jones A, Kalpaxis P, Iqbal R, Momeni Y, Nguyen A | title = Shaping markets to benefit global health - A 15-year history and lessons learned from the pentavalent vaccine market | journal = Vaccine | volume = 2 | pages = 100033 | date = August 2019 | pmid = 31384748 | pmc = 6668221 | doi = 10.1016/j.jvacx.2019.100033 }}
File:Pentavalent per-dose price ranges, to UNICEF, 2005–2019. Figure 7.jpg|alt=All pentavalent vaccine prices fell and price discrimination almost vanished. Graph by GAVI; non-UNICEF prices not shown|All pentavalent vaccine prices fell and price discrimination almost vanished. Graph by GAVI; non-UNICEF prices not shown.
=India=
In 2013, it was found that Pentavac PFS vaccines were being supplied with two different sets of packaging: One set with manufacturing and expiry dates was being provided to private hospitals, whereas the other set without manufacturing and expiry dates was being distributed to government hospitals.{{cite news |url=http://timesofindia.indiatimes.com/city/thiruvananthapuram/Pentavalent-vaccine-maker-claims-Unicef-exemption-on-manufacturing-dates/articleshow/27510731.cms |title=Pentavalent vaccine maker claims Unicef exemption on manufacturing dates |work=Times Of India | vauthors = Rajiv G |date=13 December 2013|access-date=3 July 2018}} It was later clarified that the undated vaccines were supplied by UNICEF and complied with Indian Law.{{cn|date=February 2023}}
=Sri Lanka=
Sri Lanka introduced Quinvaxem in January 2008. Within three months, four reports of deaths and 24 reports of suspected hypotonic-hyporesponsive episodes prompted regulatory attention and precautionary suspension of the initial vaccine lot. A subsequent death that occurred with the next lot in April 2009 led the authorities to suspend pentavalent vaccine use and resume DTwP and hepatitis B vaccination. Following an investigation by independent national and international experts, the vaccine was reintroduced in 2010.
=Bhutan=
Bhutan introduced Easyfive-TT in September 2009. The identification of five cases with encephalopathy and/or meningoencephalitis shortly after pentavalent vaccination prompted the authorities to suspend vaccination on 23 October 2009. Subsequently, four additional serious cases related to vaccine administered prior to suspension were identified and investigated. After a comprehensive review by independent national and international experts, the vaccine was reintroduced in 2011.
=Vietnam=
Between December 2012 and March 2013 nine deaths were reported in Viet Nam of children who had recently received injections of the pentavalent vaccine Quinvaxem.{{cite web|url=http://www.wpro.who.int/vietnam/mediacentre/releases/2013/who_unicef_qanda_quinvaxem_en.pdf|title=Frequently Asked Questions (FAQs) Quinvaxem vaccine|website=World Health Organization|access-date=30 June 2018}}
On 4 May 2013, the Ministry of Health of Viet Nam announced that use of Quinvaxem was suspended.{{cite web | url=https://www.who.int/immunization_standards/vaccine_quality/quinvaxem_pqnote_may2013/en/| archive-url=https://web.archive.org/web/20131111075243/http://www.who.int/immunization_standards/vaccine_quality/quinvaxem_pqnote_may2013/en/| url-status=dead| archive-date=November 11, 2013|title=Safety of Quinvaxem (DTwP-HepB-Hib) pentavalent vaccine.|website=World Health Organization|access-date=30 June 2018|date=10 May 2013}}
After a review of the cases conducted by national experts together with staff from WHO and UNICEF and an independent clinician, no link with vaccination could be identified. The fatalities reported in Viet Nam were attributed to coincidental health problems related in time but not related to the use of Quinvaxem, or cases for which the information available did not allow for a definite conclusion but there were no clinical signs that were consistent with the use of the vaccine. The WHO report emphasized that more than 400 million doses of Quinvaxem had been administered and that no fatal adverse event had ever been associated with Quinvaxem or similar vaccines.
Following additional reports from India, Sri Lanka, and Bhutan of a small number of serious adverse events following immunization with pentavalent vaccines, the WHO asked a global panel of independent experts to review the safety of the vaccine. This review took place 12–13 June 2013 and concluded that no unusual reaction could be attributed to pentavalent vaccines.{{cite web|url=https://www.who.int/vaccine_safety/committee/reports/Jun_2013/en/|archive-url=https://web.archive.org/web/20131222035219/http://www.who.int/vaccine_safety/committee/reports/Jun_2013/en/|url-status=dead|archive-date=December 22, 2013|title=Global Advisory Committee on Vaccine Safety, report of meeting held 12-13 June 2013|date=19 July 2013|access-date=3 July 2018|website=World Health Organization}} On 20 June 2013, the Ministry of Health announced that Viet Nam would resume use of Quinvaxem.{{cite web|url=https://www.who.int/immunization_standards/vaccine_quality/quinvaxem_pqnote_june2013/en/|archive-url=https://web.archive.org/web/20140830015036/http://www.who.int/immunization_standards/vaccine_quality/quinvaxem_pqnote_june2013/en/|url-status=dead|archive-date=August 30, 2014|access-date=3 July 2018|date=5 July 2013|website=World Health Organization|title=Update on quality and safety of Quinvaxem (DTwP-HepB-Hib) pentavalent vaccine.}}
The reported events in these Asian nations caused public uncertainty regarding the use of pentavalent vaccines to spread to other developing nations.{{cite news |url=http://www.thehindubusinessline.com/economy/infant-deaths-cast-shadow-on-scaleup-of-pentavalent-vaccine-use/article5157256.ece |title=Infant deaths cast shadow on scale-up of pentavalent vaccine use |work=The Hindu Business Line|date=22 September 2013|access-date=3 July 2018 | vauthors = Datta PT }} In response to this, and a corresponding spread of inaccurate information about vaccine safety, the Indian Academy of Pediatrics released a statement in support of pentavalent vaccines.{{cite news |url= http://indianexpress.com/article/cities/pune/pentavalent-vaccine-is-safe-assures-iap/ |title=Pentavalent vaccine is safe, assures IAP |work=The Indian Express|access-date=3 July 2018|date=13 September 2013| publisher = Express News Service }}
=Formulations=
Common versions of pentavalent vaccines include Quinvaxem, Pentavac PFS, Easyfive TT, ComBE Five, Shan5, and Pentabio.{{cite web |url=http://www.vaccineworldiso.com/products.php |title=Products |work=Vaccine World |access-date=2014-09-17 |archive-date=2016-04-06 |archive-url=https://web.archive.org/web/20160406235707/http://www.vaccineworldiso.com/products.php |url-status=dead }}{{cite news|url = http://www.business-standard.com/article/companies/shan5-vaccine-gets-who-nod-114050500553_1.html|title = 'Shan5' vaccine gets WHO nod|work=Business Standard|date = 2014-05-05}}
Notes
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References
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Further reading
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- {{cite journal | vauthors = Dodoo AN, Renner L, van Grootheest AC, Labadie J, Antwi-Agyei KO, Hayibor S, Addison J, Pappoe V, Appiah-Danquah A | title = Safety monitoring of a new pentavalent vaccine in the expanded programme on immunisation in Ghana | journal = Drug Safety | volume = 30 | issue = 4 | pages = 347–56 | year = 2007 | pmid = 17408311 | doi = 10.2165/00002018-200730040-00007 | s2cid = 37633844 | doi-access = free }}
- {{cite journal | vauthors = Verma R, Khanna P, Chawla S | title = Pentavalent DTP vaccine: need to be incorporated in the vaccination program of India | journal = Human Vaccines & Immunotherapeutics | volume = 9 | issue = 7 | pages = 1497–9 | date = July 2013 | pmid = 23571225 | doi = 10.4161/hv.24382 | doi-access = free }}
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External links
- {{cite web | vauthors = Quinn B | date = 6 June 2011 | url = https://www.theguardian.com/global-development/2011/jun/06/immunisation-developing-world-drugs-companies | title = Drugs companies to lower price of vaccines in developing countries | work = The Guardian }}
- {{cite news | vauthors = Dhar A | url = http://www.thehindu.com/sci-tech/health/medicine-and-research/pentavalent-vaccine-gets-clean-chit-set-for-national-scaleup/article5222381.ece | title = Pentavalent vaccine gets clean chit, set for national scale-up | newspaper = The Hindu | date = 2013-10-11 }}
- {{cite web | vauthors = Sinha V | date = 10 June 2011 | url = https://www.voanews.com/a/health-organization-gates-foundation-promote-greater-use-of-vaccines-123683009/140616.html | archive-url = https://web.archive.org/web/20160305022451/http://www.voanews.com/content/health-organization-gates-foundation-promote-greater-use-of-vaccines-123683009/140616.html | archive-date = 5 March 2016 | title = Health Organization, Gates Foundation Promote Greater Use of Vaccines | url-status = live | work = Voice of America }}
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