DTwP-HepB-Hib vaccine is a 5-in-1 combination vaccine with five individual

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 ...

s conjugated into one. It protects 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 ...

whooping cough Whooping cough ( or ), also known as pertussis or the 100-day cough, is a highly contagious, Vaccine-preventable diseases, vaccine-preventable Pathogenic bacteria, bacterial disease. Initial symptoms are usually similar to those of the common c ...

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. ...

and ''

Haemophilus influenzae ''Haemophilus influenzae'' (formerly called Pfeiffer's bacillus or ''Bacillus influenzae'') is a Gram-negative, Motility, non-motile, Coccobacillus, coccobacillary, facultative anaerobic organism, facultatively anaerobic, Capnophile, capnophili ...

'' type B, which is generally used in middle- and low-income countries, where polio vaccine is given separately. By 2013, pentavalent vaccines accounted for 100% of the DTP-containing vaccines procured by

UNICEF UNICEF ( ), originally the United Nations International Children's Emergency Fund, officially United Nations Children's Fund since 1953, is an agency of the United Nations responsible for providing Humanitarianism, humanitarian and Development a ...

, which supplies vaccines to a large proportion of the world's children.

Safety

During studies and tests, the conjugated liquid DTPw- HepB- Hib vaccine was found to have positive safety when given as a

booster Booster may refer to: Amusement rides * Booster (Fabbri ride), a pendulum ride * Booster (HUSS ride), an evolution of the Breakdance ride * Booster (KMG ride), a pendulum ride Arts, entertainment, and media Fictional characters * Booster, a cha ...

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 Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted: * Wanted immunogenicity typically relates to vaccines, where the injectio ...

History

In October 2004, 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 ...

granted marketing approval to the pentavalent vaccine Quintanrix, manufactured by

GlaxoSmithKline GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers an ...

. Quintanrix was voluntarily withdrawn by the manufacturer in 2008. In September 2006, the first pentavalent vaccine formulation received pre-qualification approval from 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 ...

. 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 The Government of India (ISO 15919, ISO: Bhārata Sarakāra, legally the Union Government or Union of India or the Central Government) is the national authority of the Republic of India, located in South Asia, consisting of States and union t ...

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. 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 GAVI, officially Gavi, the Vaccine Alliance (previously the GAVI Alliance, and before that the Global Alliance for Vaccines and Immunization) is a Public–private partnership, public–private global health partnership with the goal of incr ...

-supported countries to introduce the five-in-one vaccine.

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. In November 2010, the public-private consortium

announced that the cost of the pentavalent vaccine for emerging-market countries had dropped below US$3.00 per dose. 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. In Europe, hexavalent vaccines that also contain inactivated polio vaccine ( IPV) are in wide use. 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 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 Price discrimination (differential pricing, equity pricing, preferential pricing, dual pricing, tiered pricing, and surveillance pricing) is a Microeconomics, microeconomic Pricing strategies, pricing strategy where identical or largely similar g ...

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 hospital A private hospital is a hospital not owned by the government, including for-profit and non-profit hospitals. Funding is by patients themselves ("self-pay"), by insurers, or by foreign embassies. Private hospitals are commonly part, albeit in var ...

s, whereas the other set without manufacturing and expiry dates was being distributed to government hospitals. It was later clarified that the undated vaccines were supplied by UNICEF and complied with Indian Law.

Sri Lanka

Sri Lanka Sri Lanka, officially the Democratic Socialist Republic of Sri Lanka, also known historically as Ceylon, is an island country in South Asia. It lies in the Indian Ocean, southwest of the Bay of Bengal, separated from the Indian subcontinent, ...

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

vaccination. Following an investigation by independent national and international experts, the vaccine was reintroduced in 2010.

Bhutan

Bhutan Bhutan, officially the Kingdom of Bhutan, is a landlocked country in South Asia, in the Eastern Himalayas between China to the north and northwest and India to the south and southeast. With a population of over 727,145 and a territory of , ...

introduced Easyfive-TT in September 2009. The identification of five cases with

encephalopathy Encephalopathy (; ) means any disorder or disease of the brain, especially chronic degenerative conditions. In modern usage, encephalopathy does not refer to a single disease, but rather to a syndrome of overall brain dysfunction; this syndrome ...

and/or

meningoencephalitis Meningoencephalitis (; from ; ; and the medical suffix ''-itis'', "inflammation"), also known as herpes meningoencephalitis, is a medical condition that simultaneously resembles both meningitis, which is an infection or inflammation of the mening ...

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. On 4 May 2013, the Ministry of Health of Viet Nam announced that use of Quinvaxem was suspended. 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 India, officially the Republic of India, is a country in South Asia. It is the List of countries and dependencies by area, seventh-largest country by area; the List of countries by population (United Nations), most populous country since ...

, Sri Lanka, and Bhutan of a small number of serious

adverse event In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medicati ...

s 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. On 20 June 2013, the Ministry of Health announced that Viet Nam would resume use of Quinvaxem. The reported events in these Asian nations caused public uncertainty regarding the use of pentavalent vaccines to spread to other developing nations. 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.

Formulations

Common versions of pentavalent vaccines include Quinvaxem, Pentavac PFS, Easyfive TT, ComBE Five, Shan5, and Pentabio.

Notes

References

External links

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