A pentavalent vaccine, also known as a 5-in-1 vaccine, is a combination vaccine with five individual

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

s conjugated into one. Pentavalent vaccine frequently refers to the 5-in-1 vaccine protecting against

diphtheria Diphtheria is an infection caused by the bacterium '' Corynebacterium diphtheriae''. Most infections are asymptomatic or have a mild clinical course, but in some outbreaks more than 10% of those diagnosed with the disease may die. Signs and s ...

tetanus Tetanus, also known as lockjaw, is a bacterial infection caused by ''Clostridium tetani'', and is 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 ...

whooping cough Whooping cough, also known as pertussis or the 100-day cough, is a highly contagious bacterial disease. Initial symptoms are usually similar to those of the common cold with a runny nose, fever, and mild cough, but these are followed by two or t ...

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 type B ''Haemophilus influenzae'' (formerly called Pfeiffer's bacillus or ''Bacillus influenzae'') is a Gram-negative, non-motile, coccobacillary, facultatively anaerobic, capnophilic pathogenic bacterium of the family Pasteurellaceae. The bacter ...

'', which is generally used in middle- and low-income countries, where polio vaccine is given separately. Another pentavalent vaccine is the 5-in-1 vaccine that protects against diphtheria, tetanus, whooping cough,

polio Poliomyelitis, commonly shortened to polio, is an infectious disease caused by the poliovirus. Approximately 70% of cases are asymptomatic; mild symptoms which can occur include sore throat and fever; in a proportion of cases more severe s ...

, and ''Haemophilus influenza type B'', which was used in the UK until 2017, following which a 6-in-1 vaccine became available containing the additional protection against hepatitis B. By 2013, pentavalent vaccines accounted for 100% of the DTP-containing vaccines procured by

UNICEF UNICEF (), originally called the United Nations International Children's Emergency Fund in full, now officially United Nations Children's Fund, is an agency of the United Nations responsible for providing humanitarian and developmental aid to ...

, 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 granted marketing approval within the EU to the pentavalent vaccine Quintanrix, manufactured by GlaxoSmithKline. 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 specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...

. In 2012,

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: ; often abbreviated as GoI), known as the Union Government or Central Government but often simply as the Centre, is the national government of the Republic of India, a federal democracy located in South Asia, ...

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 global health partnership with the goal of increasing access to immunization ...

-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

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 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 dipht ...

that also contain inactivated polio vaccine ( IPV) are in wide use. In the US, the two pentavalent vaccines that have received marketing approval contain IPV rather than hepatitis B vaccine (

DTaP-IPV/Hib vaccine DTaP-IPV/Hib vaccine is a 5-in-1 combination vaccine that protects against diphtheria, tetanus, whooping cough, polio, and ''Haemophilus influenzae type B''. Its generic name is 'diphtheria and tetanus toxoids and acellular pertussis adsorbed, ...

) or Hib vaccine (

DTaP-IPV-HepB vaccine 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 ...

). File:Prequalified pentavalent and years of sales to UNICEF. Figure 5.jpg, The number of manufacturers making certified pentavalent vaccine. File:Pentavalent per-dose price ranges, to UNICEF, 2005–2019. Figure 7.jpg, All pentavalent vaccine prices fell and

price discrimination Price discrimination is a microeconomic pricing strategy where identical or largely similar goods or services are sold at different prices by the same provider in different markets. Price discrimination is distinguished from product differe ...

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-profits and non-profits. Funding is by patients themselves ("self-pay"), by insurers, or by foreign embassies. Private hospitals are commonly part, albeit in varying deg ...

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

and complied with

Indian Law The legal system of India consists of civil, common law and customary, Islamic ethics, or religious law within the legal framework inherited from the colonial era and various legislation first introduced by the British are still in effect i ...

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

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

Bhutan

Bhutan Bhutan (; dz, འབྲུག་ཡུལ་, Druk Yul ), officially the Kingdom of Bhutan,), is a landlocked country in South Asia. It is situated in the Eastern Himalayas, between China in the north and India in the south. A mountainou ...

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

encephalopathy Encephalopathy (; from grc, ἐνκέφαλος "brain" + πάθος "suffering") means any disorder or disease of the brain, especially chronic degenerative conditions. In modern usage, encephalopathy does not refer to a single disease, but r ...

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 menin ...

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 Vietnam or Viet Nam ( vi, Việt Nam, ), officially the Socialist Republic of Vietnam,., group="n" is a country in Southeast Asia, at the eastern edge of mainland Southeast Asia, with an area of and population of 96 million, making it ...

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 (Hindi: ), is a country in South Asia. It is the seventh-largest country by area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the so ...

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

adverse event An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...

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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